Label: ATOMOXETINE capsule
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NDC Code(s):
65841-605-02,
65841-605-06,
65841-605-10,
65841-605-14, view more65841-605-16, 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
Drug Label Information
Updated November 25, 2024
If you are a healthcare professional or from the pharmaceutical industry please visit this version.
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- SPL UNCLASSIFIED SECTION
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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
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INGREDIENTS AND APPEARANCE
ATOMOXETINE
atomoxetine capsuleProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65841-606 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ATOMOXETINE HYDROCHLORIDE (UNII: 57WVB6I2W0) (ATOMOXETINE - UNII:ASW034S0B8) ATOMOXETINE 18 mg Inactive Ingredients Ingredient Name Strength 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 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 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 Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA079017 12/06/2017 ATOMOXETINE
atomoxetine capsuleProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65841-607 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ATOMOXETINE HYDROCHLORIDE (UNII: 57WVB6I2W0) (ATOMOXETINE - UNII:ASW034S0B8) ATOMOXETINE 25 mg Inactive Ingredients Ingredient Name Strength 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 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 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 Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA079017 12/06/2017 ATOMOXETINE
atomoxetine capsuleProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65841-608 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ATOMOXETINE HYDROCHLORIDE (UNII: 57WVB6I2W0) (ATOMOXETINE - UNII:ASW034S0B8) ATOMOXETINE 40 mg Inactive Ingredients Ingredient Name Strength 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 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 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 Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA079017 12/06/2017 ATOMOXETINE
atomoxetine capsuleProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65841-609 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ATOMOXETINE HYDROCHLORIDE (UNII: 57WVB6I2W0) (ATOMOXETINE - UNII:ASW034S0B8) ATOMOXETINE 60 mg Inactive Ingredients Ingredient Name Strength 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 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 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 Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA079017 12/06/2017 ATOMOXETINE
atomoxetine capsuleProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65841-610 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ATOMOXETINE HYDROCHLORIDE (UNII: 57WVB6I2W0) (ATOMOXETINE - UNII:ASW034S0B8) ATOMOXETINE 80 mg Inactive Ingredients Ingredient Name Strength 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 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 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 Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA079017 12/06/2017 ATOMOXETINE
atomoxetine capsuleProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65841-611 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ATOMOXETINE HYDROCHLORIDE (UNII: 57WVB6I2W0) (ATOMOXETINE - UNII:ASW034S0B8) ATOMOXETINE 100 mg Inactive Ingredients Ingredient Name Strength 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 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 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 Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA079017 12/06/2017 ATOMOXETINE
atomoxetine capsuleProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65841-605 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ATOMOXETINE HYDROCHLORIDE (UNII: 57WVB6I2W0) (ATOMOXETINE - UNII:ASW034S0B8) ATOMOXETINE 10 mg Inactive Ingredients Ingredient Name Strength 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 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 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 Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA079017 04/05/2023 Labeler - Zydus Lifesciences Limited (918596198) Registrant - Zydus Lifesciences Limited (918596198) Establishment Name Address ID/FEI Business Operations 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)