NDC Code(s) : 68084-656-11, 68084-656-01, 68084-663-11, 68084-663-21
Packager : American Health Packaging

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Azithromycin Dihydrateazithromycin TABLET, FILM COATED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68084-656(NDC:60505-2581)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AZITHROMYCIN DIHYDRATE(UNII: 5FD1131I7S)
(AZITHROMYCIN ANHYDROUS - UNII:J2KLZ20U1M) 		AZITHROMYCIN ANHYDROUS250 mg
Inactive Ingredients
Ingredient Name Strength
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE(UNII: O7TSZ97GEP)
HYDROXYPROPYL CELLULOSE (TYPE H)(UNII: RFW2ET671P)
CROSCARMELLOSE SODIUM(UNII: M28OL1HH48)
MAGNESIUM STEARATE(UNII: 70097M6I30)
HYPROMELLOSES(UNII: 3NXW29V3WO)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
TRIACETIN(UNII: XHX3C3X673)
Product Characteristics
Color white Score no score
Shape OVAL Size 13 mm
Flavor Imprint Code APO;AZ250
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:68084-656-01100 in 1 BOX, UNIT-DOSE 17/02/2014
1NDC:68084-656-111 in 1 BLISTER PACK Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA065507 02/17/2014 10/31/2015
Azithromycin Dihydrateazithromycin TABLET, FILM COATED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68084-663(NDC:60505-2582)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AZITHROMYCIN DIHYDRATE(UNII: 5FD1131I7S)
(AZITHROMYCIN ANHYDROUS - UNII:J2KLZ20U1M) 		AZITHROMYCIN ANHYDROUS500 mg
Inactive Ingredients
Ingredient Name Strength
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE(UNII: O7TSZ97GEP)
HYDROXYPROPYL CELLULOSE (TYPE H)(UNII: RFW2ET671P)
CROSCARMELLOSE SODIUM(UNII: M28OL1HH48)
MAGNESIUM STEARATE(UNII: 70097M6I30)
HYPROMELLOSES(UNII: 3NXW29V3WO)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
TRIACETIN(UNII: XHX3C3X673)
Product Characteristics
Color white Score no score
Shape OVAL Size 16 mm
Flavor Imprint Code APO;AZ500
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:68084-663-2130 in 1 BOX, UNIT-DOSE 17/02/2014
1NDC:68084-663-111 in 1 BLISTER PACK Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA065509 02/17/2014 06/16/2016

PRINCIPAL DISPLAY PANEL

1013_Azithromycin_250mg_10x10

PRINCIPAL DISPLAY PANEL

1013_Azithromycin_500mg_3x10