Clindamycin Hydrochloride (Page 4 of 4)

PRINCIPAL DISPLAY PANEL — 150 mg

NDC 0527-1382 -01

Clindamycin HClCapsules, USP

150 mg*

Rx Only

100 Capsules

Lanne tt

150 mg
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 300 mg

NDC 0527-1383 -01

Clindamycin HClCapsules, USP

300 mg*

Rx Only

100 Capsules

Lanne tt

300 mg
(click image for full-size original)
CLINDAMYCIN HYDROCHLORIDE clindamycin hydrochloride capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0527-1381
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
LACTOSE MONOHYDRATE
STARCH, CORN
MAGNESIUM STEARATE
TALC
GELATIN
D&C YELLOW NO. 10
FD&C GREEN NO. 3
SHELLAC
ALCOHOL
TITANIUM DIOXIDE
ISOPROPYL ALCOHOL
AMMONIA
BUTYL ALCOHOL
PROPYLENE GLYCOL
SILICON DIOXIDE
Product Characteristics
Color green (light green) Score no score
Shape CAPSULE Size 15mm
Flavor Imprint Code Lannett;1381
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0527-1381-01 100 CAPSULE in 1 BOTTLE None
2 NDC:0527-1381-04 200 CAPSULE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA065243 08/12/2005
CLINDAMYCIN HYDROCHLORIDE clindamycin hydrochloride capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0527-1382
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
LACTOSE MONOHYDRATE
STARCH, CORN
MAGNESIUM STEARATE
TALC
GELATIN
D&C RED NO. 33
D&C YELLOW NO. 10
FD&C BLUE NO. 1
FD&C GREEN NO. 3
TITANIUM DIOXIDE
SHELLAC
ALCOHOL
ISOPROPYL ALCOHOL
AMMONIA
BUTYL ALCOHOL
PROPYLENE GLYCOL
SILICON DIOXIDE
Product Characteristics
Color blue (light blue opaque cap) , green (light green body) Score no score
Shape CAPSULE Size 19mm
Flavor Imprint Code Lannett;1382
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0527-1382-01 100 CAPSULE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA065243 08/12/2005
CLINDAMYCIN HYDROCHLORIDE clindamycin hydrochloride capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0527-1383
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
LACTOSE MONOHYDRATE
STARCH, CORN
MAGNESIUM STEARATE
TALC
GELATIN
D&C RED NO. 33
FD&C BLUE NO. 1
FD&C GREEN NO. 3
TITANIUM DIOXIDE
SHELLAC
ALCOHOL
ISOPROPYL ALCOHOL
AMMONIA
BUTYL ALCOHOL
PROPYLENE GLYCOL
SILICON DIOXIDE
Product Characteristics
Color blue (light blue opaque) Score no score
Shape CAPSULE Size 22mm
Flavor Imprint Code Lannett;1383
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0527-1383-02 16 CAPSULE in 1 BOTTLE None
2 NDC:0527-1383-01 100 CAPSULE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA065243 08/12/2005
Labeler — Lannett Company, Inc. (002277481)
Establishment
Name Address ID/FEI Operations
Lannett Company, Inc. 829757603 analysis (0527-1381), analysis (0527-1382), analysis (0527-1383)
Establishment
Name Address ID/FEI Operations
Lannett Company, Inc. 006422406 label (0527-1381), label (0527-1382), label (0527-1383), manufacture (0527-1381), manufacture (0527-1382), manufacture (0527-1383), pack (0527-1381), pack (0527-1382), pack (0527-1383)

Revised: 08/2020 Lannett Company, Inc.

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