Label: CLOMIPRAMINE HYDROCHLORIDE capsule
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NDC Code(s):
70771-1012-1,
70771-1012-7,
70771-1012-9,
70771-1013-1, view more70771-1013-7, 70771-1013-9, 70771-1014-1, 70771-1014-7, 70771-1014-9
- Packager: Zydus Lifesciences Limited
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated September 21, 2023
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INGREDIENTS AND APPEARANCE
CLOMIPRAMINE HYDROCHLORIDE
clomipramine hydrochloride capsuleProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1012 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CLOMIPRAMINE HYDROCHLORIDE (UNII: 2LXW0L6GWJ) (CLOMIPRAMINE - UNII:NUV44L116D) CLOMIPRAMINE HYDROCHLORIDE 25 mg Inactive Ingredients Ingredient Name Strength ALCOHOL (UNII: 3K9958V90M) AMMONIA (UNII: 5138Q19F1X) BUTYL ALCOHOL (UNII: 8PJ61P6TS3) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) D&C RED NO. 28 (UNII: 767IP0Y5NH) D&C RED NO. 33 (UNII: 9DBA0SBB0L) D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FD&C RED NO. 40 (UNII: WZB9127XOA) FERROSOFERRIC OXIDE (UNII: XM0M87F357) GELATIN (UNII: 2G86QN327L) ISOPROPYL ALCOHOL (UNII: ND2M416302) MAGNESIUM STEARATE (UNII: 70097M6I30) 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 PINK (OPAQUE PINK CAP) , PINK (OPAQUE LIGHT PINK BODY) Score no score Shape CAPSULE (CAPSULE) Size 18mm Flavor Imprint Code 1065 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70771-1012-9 90 in 1 BOTTLE; Type 0: Not a Combination Product 05/03/2018 2 NDC:70771-1012-7 30 in 1 BOTTLE; Type 0: Not a Combination Product 05/03/2018 3 NDC:70771-1012-1 100 in 1 BOTTLE; Type 0: Not a Combination Product 05/03/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA208961 05/03/2018 CLOMIPRAMINE HYDROCHLORIDE
clomipramine hydrochloride capsuleProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1013 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CLOMIPRAMINE HYDROCHLORIDE (UNII: 2LXW0L6GWJ) (CLOMIPRAMINE - UNII:NUV44L116D) CLOMIPRAMINE HYDROCHLORIDE 50 mg Inactive Ingredients Ingredient Name Strength ALCOHOL (UNII: 3K9958V90M) AMMONIA (UNII: 5138Q19F1X) BUTYL ALCOHOL (UNII: 8PJ61P6TS3) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) D&C RED NO. 33 (UNII: 9DBA0SBB0L) FD&C RED NO. 40 (UNII: WZB9127XOA) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) GELATIN (UNII: 2G86QN327L) ISOPROPYL ALCOHOL (UNII: ND2M416302) MAGNESIUM STEARATE (UNII: 70097M6I30) 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 YELLOW (OPAQUE YELLOW CAP) , PINK (OPAQUE LIGHT PINK BODY) Score no score Shape CAPSULE (CAPSULE) Size 19mm Flavor Imprint Code 1066 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70771-1013-7 30 in 1 BOTTLE; Type 0: Not a Combination Product 05/03/2018 2 NDC:70771-1013-1 100 in 1 BOTTLE; Type 0: Not a Combination Product 05/03/2018 3 NDC:70771-1013-9 90 in 1 BOTTLE; Type 0: Not a Combination Product 05/03/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA208961 05/03/2018 CLOMIPRAMINE HYDROCHLORIDE
clomipramine hydrochloride capsuleProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1014 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CLOMIPRAMINE HYDROCHLORIDE (UNII: 2LXW0L6GWJ) (CLOMIPRAMINE - UNII:NUV44L116D) CLOMIPRAMINE HYDROCHLORIDE 75 mg Inactive Ingredients Ingredient Name Strength ALCOHOL (UNII: 3K9958V90M) AMMONIA (UNII: 5138Q19F1X) BUTYL ALCOHOL (UNII: 8PJ61P6TS3) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) D&C RED NO. 28 (UNII: 767IP0Y5NH) D&C RED NO. 33 (UNII: 9DBA0SBB0L) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FD&C RED NO. 40 (UNII: WZB9127XOA) FERROSOFERRIC OXIDE (UNII: XM0M87F357) GELATIN (UNII: 2G86QN327L) ISOPROPYL ALCOHOL (UNII: ND2M416302) MAGNESIUM STEARATE (UNII: 70097M6I30) 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 PINK (OPAQUE DARK PINK CAP) , PINK (OPAQUE LIGHT PINK BODY) Score no score Shape CAPSULE (CAPSULE) Size 19mm Flavor Imprint Code 1067 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70771-1014-7 30 in 1 BOTTLE; Type 0: Not a Combination Product 05/03/2018 2 NDC:70771-1014-1 100 in 1 BOTTLE; Type 0: Not a Combination Product 05/03/2018 3 NDC:70771-1014-9 90 in 1 BOTTLE; Type 0: Not a Combination Product 05/03/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA208961 05/03/2018 Labeler - Zydus Lifesciences Limited (918596198) Registrant - Zydus Lifesciences Limited (918596198) Establishment Name Address ID/FEI Business Operations Zydus Lifesciences Limited 863362789 ANALYSIS(70771-1012, 70771-1013, 70771-1014) , MANUFACTURE(70771-1012, 70771-1013, 70771-1014)
