NDC Code(s) : 68180-861-11, 68180-861-06, 68180-861-13, 68180-862-11, 68180-862-06, 68180-862-13
Packager : Lupin Pharmaceuticals, Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

azithromycin dihydrateazithromycin dihydrate TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68180-861
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, 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 14 mm
Flavor Imprint Code LU;L04
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:68180-861-116 in 1 BLISTER PACK Type 0: Not a Combination Product17/11/2022
2NDC:68180-861-0630 in 1 CONTAINER Type 0: Not a Combination Product17/11/2022
3NDC:68180-861-133 in 1 CARTON 17/11/2022
36 in 1 BLISTER PACK Type 0: Not a Combination Product17/11/2022
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA065398 11/17/2022
azithromycin dihydrateazithromycin dihydrate TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68180-862
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, 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;L05
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:68180-862-111 in 1 CARTON 17/11/2022
13 in 1 BLISTER PACK Type 0: Not a Combination Product
2NDC:68180-862-0630 in 1 CONTAINER Type 0: Not a Combination Product17/11/2022
3NDC:68180-862-133 in 1 CARTON 17/11/2022
33 in 1 BLISTER PACK Type 0: Not a Combination Product17/11/2022
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA065399 08/18/2015

LABELER - Lupin Pharmaceuticals, Inc.(089153071)

REGISTRANT - LUPIN LIMITED(675923163)

Establishment
Name Address ID/FEI Business Operations
LUPIN LIMITED 677600414 MANUFACTURE(68180-861, 68180-862), PACK(68180-861, 68180-862)