NDC Code(s) : 61919-829-30, 61919-829-21, 61919-829-40
Packager : Direct Rx

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Clindamycin HydrochlorideClindamycin Hydrochloride CAPSULE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:61919-829(NDC:0527-1383)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CLINDAMYCIN HYDROCHLORIDE(UNII: T20OQ1YN1W)
(CLINDAMYCIN - UNII:3U02EL437C) 		CLINDAMYCIN300 mg
Inactive Ingredients
Ingredient Name Strength
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
STARCH, CORN(UNII: O8232NY3SJ)
MAGNESIUM STEARATE(UNII: 70097M6I30)
TALC(UNII: 7SEV7J4R1U)
GELATIN(UNII: 2G86QN327L)
D&C RED NO. 33(UNII: 9DBA0SBB0L)
FD&C BLUE NO. 1(UNII: H3R47K3TBD)
FD&C GREEN NO. 3(UNII: 3P3ONR6O1S)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
SHELLAC(UNII: 46N107B71O)
ALCOHOL(UNII: 3K9958V90M)
ISOPROPYL ALCOHOL(UNII: ND2M416302)
AMMONIA(UNII: 5138Q19F1X)
BUTYL ALCOHOL(UNII: 8PJ61P6TS3)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
Product Characteristics
Color blue Score no score
Shape capsule Size 22 mm
Flavor Imprint Code Lannett;1383
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:61919-829-3030 in 1 BOTTLE Type 0: Not a Combination Product
2NDC:61919-829-2121 in 1 BOTTLE Type 0: Not a Combination Product01/01/2015
3NDC:61919-829-4040 in 1 BOTTLE Type 0: Not a Combination Product01/01/2015
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA065243 01/01/2015

LABELER - Direct Rx(079254320)

Establishment
Name Address ID/FEI Business Operations
Direct Rx 079254320 repack(61919-829), relabel(61919-829)

PRINCIPAL DISPLAY PANEL

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