CLINDAMYCIN HYDROCHLORIDE - clindamycin hydrochloride capsule, gelatin coated 
Zydus Lifesciences Limited

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Clindamycin Hydrochloride Capsules, USP

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 70771-1136-1 in bottle of 100 Capsules

Clindamycin Hydrochloride Capsules USP, 75 mg

Rx only

100 Capsules

Clindamycin HCL Capsules USP, 75 mg

NDC 70771-1137-1 in bottle of 100 Capsules

Clindamycin Hydrochloride Capsules USP, 150 mg

Rx only

100 Capsules

Clindamycin HCL Capsules USP, 150 mg

NDC 70771-1183-1 in bottle of 100 Capsules

Clindamycin Hydrochloride Capsules USP, 300 mg

Rx only

100 Capsules

Clindamycin HCL Capsules USP, 300 mg
CLINDAMYCIN HYDROCHLORIDE 
clindamycin hydrochloride capsule, gelatin coated
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1136
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CLINDAMYCIN HYDROCHLORIDE (UNII: T20OQ1YN1W) (CLINDAMYCIN - UNII:3U02EL437C) CLINDAMYCIN75 mg
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C RED NO. 3 (UNII: PN2ZH5LOQY)  
GELATIN (UNII: 2G86QN327L)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorBLUE (BLUE (CAP)) , BLUE (BLUE (BODY)) Scoreno score
ShapeCAPSULE (CAPSULE) Size18mm
FlavorImprint Code Z;89
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1136-816 in 1 BOTTLE; Type 0: Not a Combination Product11/23/2017
2NDC:70771-1136-1100 in 1 BOTTLE; Type 0: Not a Combination Product11/23/2017
3NDC:70771-1136-5500 in 1 BOTTLE; Type 0: Not a Combination Product11/23/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA06521711/17/2017
CLINDAMYCIN HYDROCHLORIDE 
clindamycin hydrochloride capsule, gelatin coated
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1137
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CLINDAMYCIN HYDROCHLORIDE (UNII: T20OQ1YN1W) (CLINDAMYCIN - UNII:3U02EL437C) CLINDAMYCIN150 mg
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C RED NO. 3 (UNII: PN2ZH5LOQY)  
GELATIN (UNII: 2G86QN327L)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorBLUE (BLUE (CAP)) , BLUE (BLUE (BODY)) Scoreno score
ShapeCAPSULE (CAPSULE) Size20mm
FlavorImprint Code Z;90
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1137-816 in 1 BOTTLE; Type 0: Not a Combination Product11/23/2017
2NDC:70771-1137-1100 in 1 BOTTLE; Type 0: Not a Combination Product11/23/2017
3NDC:70771-1137-5500 in 1 BOTTLE; Type 0: Not a Combination Product11/23/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA06521711/23/2017
CLINDAMYCIN HYDROCHLORIDE 
clindamycin hydrochloride capsule, gelatin coated
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1183
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CLINDAMYCIN HYDROCHLORIDE (UNII: T20OQ1YN1W) (CLINDAMYCIN - UNII:3U02EL437C) CLINDAMYCIN300 mg
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C RED NO. 3 (UNII: PN2ZH5LOQY)  
GELATIN (UNII: 2G86QN327L)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorBLUE (BLUE (CAP)) , BLUE (BLUE (BODY)) Scoreno score
ShapeCAPSULE (CAPSULE) Size21mm
FlavorImprint Code Z;91
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1183-816 in 1 BOTTLE; Type 0: Not a Combination Product11/23/2017
2NDC:70771-1183-1100 in 1 BOTTLE; Type 0: Not a Combination Product11/23/2017
3NDC:70771-1183-5500 in 1 BOTTLE; Type 0: Not a Combination Product11/23/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA06521711/23/2017
Labeler - Zydus Lifesciences Limited (918596198)
Registrant - Zydus Lifesciences Limited (918596198)
Establishment
NameAddressID/FEIBusiness Operations
Zydus Lifesciences Limited918596198ANALYSIS(70771-1136, 70771-1137, 70771-1183) , MANUFACTURE(70771-1136, 70771-1137, 70771-1183)

Revised: 10/2022
Document Id: 980662dc-3ed2-4181-b2b9-4795eb815638
Set id: 94e5258b-6e2e-4d94-a644-44ef0780674b
Version: 6
Effective Time: 20221013
 
Zydus Lifesciences Limited