NDC Code(s) : 68071-3169-6, 68071-3169-5
Packager : NuCare Pharmaceuticals, Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

azithromycin monohydrateazithromycin monohydrate TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68071-3169(NDC:68180-161)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AZITHROMYCIN MONOHYDRATE(UNII: JTE4MNN1MD)
(AZITHROMYCIN ANHYDROUS - UNII:J2KLZ20U1M) 		AZITHROMYCIN ANHYDROUS500 mg
Inactive Ingredients
Ingredient Name Strength
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS(UNII: L11K75P92J)
CROSCARMELLOSE SODIUM(UNII: M28OL1HH48)
D&C RED NO. 30(UNII: 2S42T2808B)
HYPROMELLOSE 2910 (15 MPA.S)(UNII: 36SFW2JZ0W)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE(UNII: 70097M6I30)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
TRIACETIN(UNII: XHX3C3X673)
Product Characteristics
Color pink Score no score
Shape OVAL Size 17 mm
Flavor Imprint Code LU;L12
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:68071-3169-66 in 1 BOTTLE Type 0: Not a Combination Product15/03/2017
2NDC:68071-3169-55 in 1 BOTTLE Type 0: Not a Combination Product15/03/2017
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA065399 07/22/2015

LABELER - NuCare Pharmaceuticals, Inc.(010632300)

Establishment
Name Address ID/FEI Business Operations
NuCare Pharmaceuticals, Inc. 010632300 repack(68071-3169)

PRINCIPAL DISPLAY PANEL

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