Clindamycin Hydrochloride

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

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
(click image for full-size original)

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
(click image for full-size original)

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
(click image for full-size original)
CLINDAMYCIN HYDROCHLORIDE
clindamycin hydrochloride capsule, gelatin coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1136
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CLINDAMYCIN HYDROCHLORIDE (CLINDAMYCIN) CLINDAMYCIN 75 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
FD&C BLUE NO. 1
FD&C RED NO. 3
GELATIN
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
TALC
TITANIUM DIOXIDE
Product Characteristics
Color BLUE (BLUE (CAP)) , BLUE (BLUE (BODY)) Score no score
Shape CAPSULE (CAPSULE) Size 18mm
Flavor Imprint Code Z;89
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70771-1136-8 16 CAPSULE, GELATIN COATED in 1 BOTTLE None
2 NDC:70771-1136-1 100 CAPSULE, GELATIN COATED in 1 BOTTLE None
3 NDC:70771-1136-5 500 CAPSULE, GELATIN COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA065217 11/17/2017
CLINDAMYCIN HYDROCHLORIDE
clindamycin hydrochloride capsule, gelatin coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1137
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CLINDAMYCIN HYDROCHLORIDE (CLINDAMYCIN) CLINDAMYCIN 150 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
FD&C BLUE NO. 1
FD&C RED NO. 3
GELATIN
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
TALC
TITANIUM DIOXIDE
Product Characteristics
Color BLUE (BLUE (CAP)) , BLUE (BLUE (BODY)) Score no score
Shape CAPSULE (CAPSULE) Size 20mm
Flavor Imprint Code Z;90
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70771-1137-8 16 CAPSULE, GELATIN COATED in 1 BOTTLE None
2 NDC:70771-1137-1 100 CAPSULE, GELATIN COATED in 1 BOTTLE None
3 NDC:70771-1137-5 500 CAPSULE, GELATIN COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA065217 11/23/2017
CLINDAMYCIN HYDROCHLORIDE
clindamycin hydrochloride capsule, gelatin coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1183
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CLINDAMYCIN HYDROCHLORIDE (CLINDAMYCIN) CLINDAMYCIN 300 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
FD&C BLUE NO. 1
FD&C RED NO. 3
GELATIN
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
TALC
TITANIUM DIOXIDE
Product Characteristics
Color BLUE (BLUE (CAP)) , BLUE (BLUE (BODY)) Score no score
Shape CAPSULE (CAPSULE) Size 21mm
Flavor Imprint Code Z;91
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70771-1183-8 16 CAPSULE, GELATIN COATED in 1 BOTTLE None
2 NDC:70771-1183-1 100 CAPSULE, GELATIN COATED in 1 BOTTLE None
3 NDC:70771-1183-5 500 CAPSULE, GELATIN COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA065217 11/23/2017
Labeler — Zydus Lifesciences Limited (918596198)
Registrant — Zydus Lifesciences Limited (918596198)
Establishment
Name Address ID/FEI Operations
Zydus Lifesciences Limited 918596198 ANALYSIS (70771-1136), ANALYSIS (70771-1137), ANALYSIS (70771-1183), MANUFACTURE (70771-1136), MANUFACTURE (70771-1137), MANUFACTURE (70771-1183)

Revised: 10/2022 Zydus Lifesciences Limited

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