DailyMed - ATOMOXETINE capsule

NDC Code(s): 65841-605-02, 65841-605-06, 65841-605-10, 65841-605-14, view more
65841-605-16, 65841-605-30, 65841-605-77, 65841-606-02, 65841-606-06, 65841-606-10, 65841-606-14, 65841-606-16, 65841-607-02, 65841-607-06, 65841-607-10, 65841-607-14, 65841-607-16, 65841-607-30, 65841-607-77, 65841-608-02, 65841-608-06, 65841-608-10, 65841-608-14, 65841-608-16, 65841-608-30, 65841-608-77, 65841-609-02, 65841-609-06, 65841-609-10, 65841-609-14, 65841-609-16, 65841-609-30, 65841-609-77, 65841-610-02, 65841-610-06, 65841-610-10, 65841-610-14, 65841-610-16, 65841-610-30, 65841-610-77, 65841-611-02, 65841-611-06, 65841-611-10, 65841-611-14, 65841-611-16
Packager: Zydus Lifesciences Limited

Category: HUMAN PRESCRIPTION DRUG LABEL
DEA Schedule: None
Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated December 16, 2023

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SPL UNCLASSIFIED SECTION
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 65841-606-16 in bottle of 90 Capsules

Atomoxetine Capsules, 18 mg

90 Capsules

NDC 65841-607-16 in bottle of 90 Capsules

Atomoxetine Capsules, 25 mg

90 Capsules

NDC 65841-608-16 in bottle of 90 Capsules

Atomoxetine Capsules, 40 mg

90 Capsules

NDC 65841-609-16 in bottle of 90 Capsules

Atomoxetine Capsules, 60 mg

90 Capsules

NDC 65841-610-16 in bottle of 90 Capsules

Atomoxetine Capsules, 80 mg

90 Capsules

NDC 65841-611-16 in bottle of 90 Capsules

Atomoxetine Capsules, 100 mg

90 Capsules

NDC 65841-605-16 in bottle of 90 Capsules

Atomoxetine Capsules, 10 mg

90 Capsules

INGREDIENTS AND APPEARANCE

ATOMOXETINE
atomoxetine capsule

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:65841-606
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ATOMOXETINE HYDROCHLORIDE (UNII: 57WVB6I2W0) (ATOMOXETINE - UNII:ASW034S0B8)	ATOMOXETINE	18 mg

Ingredient Name	Strength
Inactive Ingredients
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
GELATIN (UNII: 2G86QN327L)
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SHELLAC (UNII: 46N107B71O)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
STARCH, CORN (UNII: O8232NY3SJ)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	YELLOW (GOLDEN) , WHITE (WHITE)	Score	no score
Shape	CAPSULE (CAPSULE)	Size	14mm
Flavor		Imprint Code	ZA;68
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:65841-606-06	30 in 1 BOTTLE; Type 0: Not a Combination Product	12/06/2017
2	NDC:65841-606-14	60 in 1 BOTTLE; Type 0: Not a Combination Product	12/06/2017
3	NDC:65841-606-16	90 in 1 BOTTLE; Type 0: Not a Combination Product	12/06/2017
4	NDC:65841-606-10	1000 in 1 BOTTLE; Type 0: Not a Combination Product	12/06/2017
5	NDC:65841-606-02	2000 in 1 BOTTLE; Type 0: Not a Combination Product	12/06/2017

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA079017	12/06/2017

ATOMOXETINE
atomoxetine capsule

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:65841-607
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ATOMOXETINE HYDROCHLORIDE (UNII: 57WVB6I2W0) (ATOMOXETINE - UNII:ASW034S0B8)	ATOMOXETINE	25 mg

Ingredient Name	Strength
Inactive Ingredients
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
GELATIN (UNII: 2G86QN327L)
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SHELLAC (UNII: 46N107B71O)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
STARCH, CORN (UNII: O8232NY3SJ)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	BLUE (OPAQUE BLUE) , WHITE (OPAQUE WHITE)	Score	no score
Shape	CAPSULE (CAPSULE)	Size	18mm
Flavor		Imprint Code	ZA69;25mg
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:65841-607-06	30 in 1 BOTTLE; Type 0: Not a Combination Product	12/06/2017
2	NDC:65841-607-14	60 in 1 BOTTLE; Type 0: Not a Combination Product	12/06/2017
3	NDC:65841-607-16	90 in 1 BOTTLE; Type 0: Not a Combination Product	12/06/2017
4	NDC:65841-607-10	1000 in 1 BOTTLE; Type 0: Not a Combination Product	12/06/2017
5	NDC:65841-607-02	2000 in 1 BOTTLE; Type 0: Not a Combination Product	12/06/2017
6	NDC:65841-607-77	10 in 1 CARTON	12/06/2017
6	NDC:65841-607-30	10 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA079017	12/06/2017

ATOMOXETINE
atomoxetine capsule

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:65841-608
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ATOMOXETINE HYDROCHLORIDE (UNII: 57WVB6I2W0) (ATOMOXETINE - UNII:ASW034S0B8)	ATOMOXETINE	40 mg

Ingredient Name	Strength
Inactive Ingredients
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)
GELATIN (UNII: 2G86QN327L)
STARCH, CORN (UNII: O8232NY3SJ)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SHELLAC (UNII: 46N107B71O)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)

Product Characteristics
Color	BLUE (OPAQUE BLUE) , BLUE (OPAQUE BLUE)	Score	no score
Shape	CAPSULE (CAPSULE)	Size	18mm
Flavor		Imprint Code	ZA70;40mg
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:65841-608-06	30 in 1 BOTTLE; Type 0: Not a Combination Product	12/06/2017
2	NDC:65841-608-14	60 in 1 BOTTLE; Type 0: Not a Combination Product	12/06/2017
3	NDC:65841-608-16	90 in 1 BOTTLE; Type 0: Not a Combination Product	12/06/2017
4	NDC:65841-608-10	1000 in 1 BOTTLE; Type 0: Not a Combination Product	12/06/2017
5	NDC:65841-608-02	2000 in 1 BOTTLE; Type 0: Not a Combination Product	12/06/2017
6	NDC:65841-608-77	10 in 1 CARTON	12/06/2017
6	NDC:65841-608-30	10 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA079017	12/06/2017

ATOMOXETINE
atomoxetine capsule

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:65841-609
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ATOMOXETINE HYDROCHLORIDE (UNII: 57WVB6I2W0) (ATOMOXETINE - UNII:ASW034S0B8)	ATOMOXETINE	60 mg

Ingredient Name	Strength
Inactive Ingredients
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
GELATIN (UNII: 2G86QN327L)
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SHELLAC (UNII: 46N107B71O)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
STARCH, CORN (UNII: O8232NY3SJ)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	BLUE (OPAQUE BLUE) , YELLOW (GOLDEN)	Score	no score
Shape	CAPSULE (CAPSULE)	Size	19mm
Flavor		Imprint Code	ZA71;60mg
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:65841-609-06	30 in 1 BOTTLE; Type 0: Not a Combination Product	12/06/2017
2	NDC:65841-609-14	60 in 1 BOTTLE; Type 0: Not a Combination Product	12/06/2017
3	NDC:65841-609-16	90 in 1 BOTTLE; Type 0: Not a Combination Product	12/06/2017
4	NDC:65841-609-10	1000 in 1 BOTTLE; Type 0: Not a Combination Product	12/06/2017
5	NDC:65841-609-02	2000 in 1 BOTTLE; Type 0: Not a Combination Product	12/06/2017
6	NDC:65841-609-77	10 in 1 CARTON	12/06/2017
6	NDC:65841-609-30	10 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA079017	12/06/2017

ATOMOXETINE
atomoxetine capsule

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:65841-610
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ATOMOXETINE HYDROCHLORIDE (UNII: 57WVB6I2W0) (ATOMOXETINE - UNII:ASW034S0B8)	ATOMOXETINE	80 mg

Ingredient Name	Strength
Inactive Ingredients
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
GELATIN (UNII: 2G86QN327L)
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SHELLAC (UNII: 46N107B71O)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
STARCH, CORN (UNII: O8232NY3SJ)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	BROWN (OPAQUE BROWN) , WHITE (WHITE)	Score	no score
Shape	CAPSULE (CAPSULE)	Size	19mm
Flavor		Imprint Code	ZA72;80mg
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:65841-610-06	30 in 1 BOTTLE; Type 0: Not a Combination Product	12/06/2017
2	NDC:65841-610-14	60 in 1 BOTTLE; Type 0: Not a Combination Product	12/06/2017
3	NDC:65841-610-16	90 in 1 BOTTLE; Type 0: Not a Combination Product	12/06/2017
4	NDC:65841-610-10	1000 in 1 BOTTLE; Type 0: Not a Combination Product	12/06/2017
5	NDC:65841-610-02	2000 in 1 BOTTLE; Type 0: Not a Combination Product	12/06/2017
6	NDC:65841-610-77	10 in 1 CARTON	12/06/2017
6	NDC:65841-610-30	10 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA079017	12/06/2017

ATOMOXETINE
atomoxetine capsule

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:65841-611
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ATOMOXETINE HYDROCHLORIDE (UNII: 57WVB6I2W0) (ATOMOXETINE - UNII:ASW034S0B8)	ATOMOXETINE	100 mg

Ingredient Name	Strength
Inactive Ingredients
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
GELATIN (UNII: 2G86QN327L)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SHELLAC (UNII: 46N107B71O)
STARCH, CORN (UNII: O8232NY3SJ)

Product Characteristics
Color	BROWN (OPAQUE BROWN) , BROWN (OPAQUE BROWN)	Score	no score
Shape	CAPSULE (CAPSULE)	Size	21mm
Flavor		Imprint Code	ZA73;100mg
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:65841-611-14	60 in 1 BOTTLE; Type 0: Not a Combination Product	12/06/2017
2	NDC:65841-611-10	1000 in 1 BOTTLE; Type 0: Not a Combination Product	12/06/2017
3	NDC:65841-611-02	2000 in 1 BOTTLE; Type 0: Not a Combination Product	12/06/2017
4	NDC:65841-611-06	30 in 1 BOTTLE; Type 0: Not a Combination Product	12/06/2017
5	NDC:65841-611-16	90 in 1 BOTTLE; Type 0: Not a Combination Product	12/06/2017

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA079017	12/06/2017

ATOMOXETINE
atomoxetine capsule

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:65841-605
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ATOMOXETINE HYDROCHLORIDE (UNII: 57WVB6I2W0) (ATOMOXETINE - UNII:ASW034S0B8)	ATOMOXETINE	10 mg

Ingredient Name	Strength
Inactive Ingredients
AMMONIA (UNII: 5138Q19F1X)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
GELATIN (UNII: 2G86QN327L)
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SHELLAC (UNII: 46N107B71O)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
STARCH, CORN (UNII: O8232NY3SJ)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color	WHITE (OPAQUE WHITE) , WHITE (OPAQUE WHITE)	Score	no score
Shape	CAPSULE (CAPSULE)	Size	11mm
Flavor		Imprint Code	ZA;67;10mg
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:65841-605-06	30 in 1 BOTTLE; Type 0: Not a Combination Product	04/05/2023
2	NDC:65841-605-16	90 in 1 BOTTLE; Type 0: Not a Combination Product	04/05/2023
3	NDC:65841-605-14	60 in 1 BOTTLE; Type 0: Not a Combination Product	04/05/2023
4	NDC:65841-605-10	1000 in 1 BOTTLE; Type 0: Not a Combination Product	04/05/2023
5	NDC:65841-605-02	2000 in 1 BOTTLE; Type 0: Not a Combination Product	04/05/2023
6	NDC:65841-605-77	10 in 1 CARTON	04/05/2023
6	NDC:65841-605-30	10 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA079017	04/05/2023

Labeler - Zydus Lifesciences Limited (918596198)

Registrant - Zydus Lifesciences Limited (918596198)

Name	Address	ID/FEI	Business Operations
Establishment
Zydus Lifesciences Limited		918596198	ANALYSIS(65841-605, 65841-606, 65841-607, 65841-608, 65841-609, 65841-610, 65841-611) , MANUFACTURE(65841-605, 65841-606, 65841-607, 65841-608, 65841-609, 65841-610, 65841-611)

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Published Date (What is this?)	Version	Files
Dec 18, 2023	6 (current)	download
Oct 14, 2022	5	download
Aug 17, 2020	4	download
Dec 3, 2019	3	download
Jan 3, 2019	2	download
Dec 7, 2017	1	download

	RxCUI	RxNorm NAME	RxTTY
1	349592	atomoxetine HCl 18 MG Oral Capsule	PSN
2	349592	atomoxetine 18 MG Oral Capsule	SCD
3	349592	atomoxetine 18 MG (as atomoxetine hydrochloride) Oral Capsule	SY
4	349593	atomoxetine HCl 25 MG Oral Capsule	PSN
5	349593	atomoxetine 25 MG Oral Capsule	SCD
6	349593	atomoxetine 25 MG (as atomoxetine hydrochloride) Oral Capsule	SY
7	349594	atomoxetine HCl 40 MG Oral Capsule	PSN
8	349594	atomoxetine 40 MG Oral Capsule	SCD
9	349594	atomoxetine 40 MG (as atomoxetine hydrochloride) Oral Capsule	SY
10	349595	atomoxetine HCl 60 MG Oral Capsule	PSN
11	349595	atomoxetine 60 MG Oral Capsule	SCD
12	349595	atomoxetine 60 MG (as atomoxetine hydrochloride) Oral Capsule	SY
13	608139	atomoxetine HCl 100 MG Oral Capsule	PSN
14	608139	atomoxetine 100 MG Oral Capsule	SCD
15	608139	atomoxetine 100 MG (as atomoxetine HCl) Oral Capsule	SY
16	608143	atomoxetine HCl 80 MG Oral Capsule	PSN
17	608143	atomoxetine 80 MG Oral Capsule	SCD
18	608143	atomoxetine 80 MG (as atomoxetine hydrochloride) Oral Capsule	SY

Label: ATOMOXETINE capsule

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	NDC
1	65841-605-02
2	65841-605-06
3	65841-605-10
4	65841-605-14
5	65841-605-16
6	65841-605-30
7	65841-605-77
8	65841-606-02
9	65841-606-06
10	65841-606-10
11	65841-606-14
12	65841-606-16
13	65841-607-02
14	65841-607-06
15	65841-607-10
16	65841-607-14
17	65841-607-16
18	65841-607-30
19	65841-607-77
20	65841-608-02
21	65841-608-06
22	65841-608-10
23	65841-608-14
24	65841-608-16
25	65841-608-30
26	65841-608-77
27	65841-609-02
28	65841-609-06
29	65841-609-10
30	65841-609-14
31	65841-609-16
32	65841-609-30
33	65841-609-77
34	65841-610-02
35	65841-610-06
36	65841-610-10
37	65841-610-14
38	65841-610-16
39	65841-610-30
40	65841-610-77
41	65841-611-02
42	65841-611-06
43	65841-611-10
44	65841-611-14
45	65841-611-16

Label: ATOMOXETINE capsule

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ATOMOXETINE capsule

Number of versions: 6

ATOMOXETINE capsule

ATOMOXETINE capsule

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ATOMOXETINE capsule

If this SPL contains inactivated NDCs listed by the FDA initiated compliance action, they will be specified as such.