CLOMIPRAMINE HYDROCHLORIDE- clomipramine hydrochloride capsule 
Zydus Lifesciences Limited

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Clomipramine Hydrochloride Capsules, USP

SPL MEDGUIDE

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 70771-1012-1

Clomipramine Hydrochloride Capsules USP, 25 mg

Rx only

100 Capsules

Clomipramine Hydrochloride Capsules, USP

NDC 70771-1013-1

Clomipramine Hydrochloride Capsules USP, 50 mg

Rx only

100 Capsules

Clomipramine Hydrochloride Capsules, USP

NDC 70771-1014-1

Clomipramine Hydrochloride Capsules USP, 75 mg

Rx only

100 Capsules

Clomipramine Hydrochloride Capsules, USP
CLOMIPRAMINE HYDROCHLORIDE 
clomipramine hydrochloride capsule
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1012
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CLOMIPRAMINE HYDROCHLORIDE (UNII: 2LXW0L6GWJ) (CLOMIPRAMINE - UNII:NUV44L116D) CLOMIPRAMINE HYDROCHLORIDE25 mg
Inactive Ingredients
Ingredient NameStrength
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
ColorPINK (OPAQUE PINK CAP) , PINK (OPAQUE LIGHT PINK BODY) Scoreno score
ShapeCAPSULE (CAPSULE) Size18mm
FlavorImprint Code 1065
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1012-990 in 1 BOTTLE; Type 0: Not a Combination Product05/03/2018
2NDC:70771-1012-730 in 1 BOTTLE; Type 0: Not a Combination Product05/03/2018
3NDC:70771-1012-1100 in 1 BOTTLE; Type 0: Not a Combination Product05/03/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20896105/03/2018
CLOMIPRAMINE HYDROCHLORIDE 
clomipramine hydrochloride capsule
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1013
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CLOMIPRAMINE HYDROCHLORIDE (UNII: 2LXW0L6GWJ) (CLOMIPRAMINE - UNII:NUV44L116D) CLOMIPRAMINE HYDROCHLORIDE50 mg
Inactive Ingredients
Ingredient NameStrength
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
ColorYELLOW (OPAQUE YELLOW CAP) , PINK (OPAQUE LIGHT PINK BODY) Scoreno score
ShapeCAPSULE (CAPSULE) Size19mm
FlavorImprint Code 1066
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1013-730 in 1 BOTTLE; Type 0: Not a Combination Product05/03/2018
2NDC:70771-1013-1100 in 1 BOTTLE; Type 0: Not a Combination Product05/03/2018
3NDC:70771-1013-990 in 1 BOTTLE; Type 0: Not a Combination Product05/03/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20896105/03/2018
CLOMIPRAMINE HYDROCHLORIDE 
clomipramine hydrochloride capsule
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1014
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CLOMIPRAMINE HYDROCHLORIDE (UNII: 2LXW0L6GWJ) (CLOMIPRAMINE - UNII:NUV44L116D) CLOMIPRAMINE HYDROCHLORIDE75 mg
Inactive Ingredients
Ingredient NameStrength
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
ColorPINK (OPAQUE DARK PINK CAP) , PINK (OPAQUE LIGHT PINK BODY) Scoreno score
ShapeCAPSULE (CAPSULE) Size19mm
FlavorImprint Code 1067
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1014-730 in 1 BOTTLE; Type 0: Not a Combination Product05/03/2018
2NDC:70771-1014-1100 in 1 BOTTLE; Type 0: Not a Combination Product05/03/2018
3NDC:70771-1014-990 in 1 BOTTLE; Type 0: Not a Combination Product05/03/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20896105/03/2018
Labeler - Zydus Lifesciences Limited (918596198)
Registrant - Zydus Lifesciences Limited (918596198)
Establishment
NameAddressID/FEIBusiness Operations
Zydus Lifesciences Limited863362789ANALYSIS(70771-1012, 70771-1013, 70771-1014) , MANUFACTURE(70771-1012, 70771-1013, 70771-1014)

Revised: 9/2023
Document Id: 43cb0e02-c8b4-4b9b-852d-c17340a3519e
Set id: db72b569-7b2c-4787-bade-7eef7299a768
Version: 6
Effective Time: 20230921
 
Zydus Lifesciences Limited