NDC Code(s) : 62332-252-30, 62332-252-03, 62332-252-09
Packager : Alembic Pharmaceuticals Inc.

Category : Human Prescription Drug Label

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Azithromycin Azithromycin TABLET, FILM COATED
Product Information
Product Type Human Prescription Drug Label Item Code (Source) NDC:62332-252
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
ANHYDROUS DIBASIC CALCIUM PHOSPHATE(UNII: L11K75P92J)
CROSCARMELLOSE SODIUM(UNII: M28OL1HH48)
HYDROXYPROPYL CELLULOSE (70000 WAMW)(UNII: 66O7AQV0RT)
MAGNESIUM STEARATE(UNII: 70097M6I30)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
HYPROMELLOSE 2910 (15 MPA.S)(UNII: 36SFW2JZ0W)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
D&C RED NO. 30(UNII: 2S42T2808B)
TRIACETIN(UNII: XHX3C3X673)
Product Characteristics
Color PINK Score no score
Shape CAPSULE Size 17 mm
Flavor Imprint Code 591;L
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:62332-252-3030 in 1 BOTTLE Type 0: Not a Combination Product29/01/2020
2NDC:62332-252-033 in 1 CARTON 29/01/2020
23 in 1 BLISTER PACK Type 0: Not a Combination Product29/01/2020
3NDC:62332-252-093 in 1 CARTON 29/01/2020
33 in 1 BLISTER PACK Type 0: Not a Combination Product29/01/2020
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA211792 01/29/2020

LABELER - Alembic Pharmaceuticals Inc.(079288842)

Establishment
Name Address ID/FEI Business Operations
Alembic Pharmaceuticals Limited 650574671 MANUFACTURE(62332-252)

PRINCIPAL DISPLAY PANEL

NDC 62332-252-30
Azithromycin
Tablets, USP
500 mg
Rx only
30 Tablets
Alembic

azithromycin-500-mg


PRINCIPAL DISPLAY PANEL

NDC 62332-252-03
Azithromycin Tablets, USP
500 mg
A full course of antibiotic therapy in 3 DAILY DOSES
Rx only
1 Card x 3 Tablets
 Alembic


azithromysin-500mg-wallet

PRINCIPAL DISPLAY PANEL

NDC 62332-252-03

Azithromycin Tablets, USP
500 mg

A full course of antibiotic therapy in 3 DAILY DOSES
Rx only
3 Cards x 3 Tablets
 Alembic

azithromycin-500mg-ct

PRINCIPAL DISPLAY PANEL

1 x 3 Tablets
Azithromycin
Tablets, USP
500 mg

blister foil

PRINCIPAL DISPLAY PANEL

NDC 62332-252-09
3 tablets per blister per monocarton
Azithromycin Tablets, USP
500 mg
A full course of antibiotic therapy in 3 DAILY DOSES
Rx only
Alembic

azithromycin-mct.jpg



PRINCIPAL DISPLAY PANEL

NDC 62332-252-09 
Azithromycin
Tablets, USP
500 mg
A full course of antibiotic therapy in 3 DAILY DOSES
3 monocartons
(3 tablets per blister per monocarton)
Rx only
Alembic

azithromycin-oct.jpg