DailyMed - PAROXETINE- paroxetine hydrochloride tablet, film coated

NDC Code(s): 65841-097-01, 65841-097-05, 65841-097-06, 65841-097-10, view more
65841-097-16, 65841-098-01, 65841-098-05, 65841-098-06, 65841-098-10, 65841-098-16, 65841-099-01, 65841-099-05, 65841-099-06, 65841-099-10, 65841-099-16, 65841-601-01, 65841-601-05, 65841-601-06, 65841-601-10, 65841-601-16
Packager: Zydus Lifesciences Limited

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

Drug Label Information

Updated October 31, 2022

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SPL MEDGUIDE
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 65841-097-05 in pack count of 500 tablets

Paroxetine Tablets USP, 10 mg

Rx only

500 tablets

NDC 65841-098-16 in pack count of 90 tablets

Paroxetine Tablets USP, 20 mg

Rx only

90 tablets

NDC 65841-099-10 in pack count of 1000 tablets

Paroxetine Tablets USP, 30 mg

Rx only

1000 tablets

NDC 65841-601-06 in pack count of 30 tablets

Paroxetine Tablets USP, 40 mg

Rx only

30 tablets

INGREDIENTS AND APPEARANCE

PAROXETINE
paroxetine hydrochloride tablet, film coated

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:65841-097
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
PAROXETINE HYDROCHLORIDE ANHYDROUS (UNII: 3I3T11UD2S) (PAROXETINE - UNII:41VRH5220H, PAROXETINE - UNII:41VRH5220H)	PAROXETINE	10 mg

Ingredient Name	Strength
Inactive Ingredients
ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)
HYPROMELLOSES (UNII: 3NXW29V3WO)
MAGNESIUM STEARATE (UNII: 70097M6I30)
POLYETHYLENE GLYCOL 6000 (UNII: 30IQX730WE)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
POVIDONE (UNII: FZ989GH94E)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	WHITE (WHITE TO OFF-WHITE)	Score	2 pieces
Shape	ROUND (ROUND)	Size	6mm
Flavor		Imprint Code	ZC;15
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:65841-097-06	30 in 1 BOTTLE; Type 0: Not a Combination Product	04/13/2007
2	NDC:65841-097-16	90 in 1 BOTTLE; Type 0: Not a Combination Product	04/13/2007
3	NDC:65841-097-01	100 in 1 BOTTLE; Type 0: Not a Combination Product	04/13/2007
4	NDC:65841-097-05	500 in 1 BOTTLE; Type 0: Not a Combination Product	04/13/2007
5	NDC:65841-097-10	1000 in 1 BOTTLE; Type 0: Not a Combination Product	04/13/2007

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA077584	04/13/2007

PAROXETINE
paroxetine hydrochloride tablet, film coated

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:65841-098
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
PAROXETINE HYDROCHLORIDE ANHYDROUS (UNII: 3I3T11UD2S) (PAROXETINE - UNII:41VRH5220H, PAROXETINE - UNII:41VRH5220H)	PAROXETINE	20 mg

Ingredient Name	Strength
Inactive Ingredients
ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)
HYPROMELLOSES (UNII: 3NXW29V3WO)
MAGNESIUM STEARATE (UNII: 70097M6I30)
POLYETHYLENE GLYCOL 6000 (UNII: 30IQX730WE)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
POVIDONE (UNII: FZ989GH94E)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	WHITE (WHITE TO OFF-WHITE)	Score	2 pieces
Shape	ROUND (ROUND)	Size	8mm
Flavor		Imprint Code	ZC;16
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:65841-098-06	30 in 1 BOTTLE; Type 0: Not a Combination Product	04/13/2007
2	NDC:65841-098-16	90 in 1 BOTTLE; Type 0: Not a Combination Product	04/13/2007
3	NDC:65841-098-01	100 in 1 BOTTLE; Type 0: Not a Combination Product	04/13/2007
4	NDC:65841-098-05	500 in 1 BOTTLE; Type 0: Not a Combination Product	04/13/2007
5	NDC:65841-098-10	1000 in 1 BOTTLE; Type 0: Not a Combination Product	04/13/2007

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA077584	04/13/2007

PAROXETINE
paroxetine hydrochloride tablet, film coated

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:65841-099
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
PAROXETINE HYDROCHLORIDE ANHYDROUS (UNII: 3I3T11UD2S) (PAROXETINE - UNII:41VRH5220H, PAROXETINE - UNII:41VRH5220H)	PAROXETINE	30 mg

Ingredient Name	Strength
Inactive Ingredients
ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)
HYPROMELLOSES (UNII: 3NXW29V3WO)
MAGNESIUM STEARATE (UNII: 70097M6I30)
POLYETHYLENE GLYCOL 6000 (UNII: 30IQX730WE)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
POVIDONE (UNII: FZ989GH94E)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	WHITE (WHITE TO OFF-WHITE)	Score	no score
Shape	ROUND (ROUND)	Size	10mm
Flavor		Imprint Code	ZC17
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:65841-099-06	30 in 1 BOTTLE; Type 0: Not a Combination Product	04/13/2007
2	NDC:65841-099-16	90 in 1 BOTTLE; Type 0: Not a Combination Product	04/13/2007
3	NDC:65841-099-01	100 in 1 BOTTLE; Type 0: Not a Combination Product	04/13/2007
4	NDC:65841-099-05	500 in 1 BOTTLE; Type 0: Not a Combination Product	04/13/2007
5	NDC:65841-099-10	1000 in 1 BOTTLE; Type 0: Not a Combination Product	04/13/2007

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA077584	04/13/2007

PAROXETINE
paroxetine hydrochloride tablet, film coated

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:65841-601
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
PAROXETINE HYDROCHLORIDE ANHYDROUS (UNII: 3I3T11UD2S) (PAROXETINE - UNII:41VRH5220H, PAROXETINE - UNII:41VRH5220H)	PAROXETINE	40 mg

Ingredient Name	Strength
Inactive Ingredients
ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)
HYPROMELLOSES (UNII: 3NXW29V3WO)
MAGNESIUM STEARATE (UNII: 70097M6I30)
POLYETHYLENE GLYCOL 6000 (UNII: 30IQX730WE)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
POVIDONE (UNII: FZ989GH94E)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	WHITE (WHITE TO OFF-WHITE)	Score	no score
Shape	ROUND (ROUND)	Size	11mm
Flavor		Imprint Code	ZC18
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:65841-601-06	30 in 1 BOTTLE; Type 0: Not a Combination Product	04/13/2007
2	NDC:65841-601-16	90 in 1 BOTTLE; Type 0: Not a Combination Product	04/13/2007
3	NDC:65841-601-01	100 in 1 BOTTLE; Type 0: Not a Combination Product	04/13/2007
4	NDC:65841-601-05	500 in 1 BOTTLE; Type 0: Not a Combination Product	04/13/2007
5	NDC:65841-601-10	1000 in 1 BOTTLE; Type 0: Not a Combination Product	04/13/2007

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA077584	04/13/2007

Labeler - Zydus Lifesciences Limited (918596198)

Registrant - Zydus Lifesciences Limited (918596198)

Name	Address	ID/FEI	Business Operations
Establishment
Zydus Lifesciences Limited		918596198	ANALYSIS(65841-097, 65841-098, 65841-099, 65841-601) , MANUFACTURE(65841-097, 65841-098, 65841-099, 65841-601)

Name	Address	ID/FEI	Business Operations
Establishment
Zydus Lifesciences Limited		677605858	MANUFACTURE(65841-097, 65841-098, 65841-099, 65841-601)

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Published Date (What is this?)	Version	Files
Nov 2, 2022	11 (current)	download
Dec 10, 2020	10	download
Oct 6, 2020	9	download
Dec 16, 2019	7	download
Dec 13, 2018	6	download
Nov 24, 2017	5	download
Feb 21, 2012	4	download
Dec 2, 2011	3	download
Apr 13, 2011	1	download

	RxCUI	RxNorm NAME	RxTTY
1	1738483	PARoxetine HCl 10 MG Oral Tablet	PSN
2	1738483	paroxetine hydrochloride 10 MG Oral Tablet	SCD
3	1738495	PARoxetine HCl 20 MG Oral Tablet	PSN
4	1738495	paroxetine hydrochloride 20 MG Oral Tablet	SCD
5	1738503	PARoxetine HCl 30 MG Oral Tablet	PSN
6	1738503	paroxetine hydrochloride 30 MG Oral Tablet	SCD
7	1738511	PARoxetine HCl 40 MG Oral Tablet	PSN
8	1738511	paroxetine hydrochloride 40 MG Oral Tablet	SCD

Label: PAROXETINE- paroxetine hydrochloride tablet, film coated

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	NDC
1	65841-097-01
2	65841-097-05
3	65841-097-06
4	65841-097-10
5	65841-097-16
6	65841-098-01
7	65841-098-05
8	65841-098-06
9	65841-098-10
10	65841-098-16
11	65841-099-01
12	65841-099-05
13	65841-099-06
14	65841-099-10
15	65841-099-16
16	65841-601-01
17	65841-601-05
18	65841-601-06
19	65841-601-10
20	65841-601-16

Label: PAROXETINE- paroxetine hydrochloride tablet, film coated

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VIEW MORE

Drug Label Info

Safety

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More Info For This Drug

Drug Label Information

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Safety

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More Info on this Drug

PAROXETINE- paroxetine hydrochloride tablet, film coated

Number of versions: 9

PAROXETINE- paroxetine hydrochloride tablet, film coated

PAROXETINE- paroxetine hydrochloride tablet, film coated

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PAROXETINE- paroxetine hydrochloride tablet, film coated

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