Azithromycin (Page 8 of 8)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL — 500 mg — Bottle Label

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL — 500 mg — Wallet Pack

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 TabletsAlembic

1 card x 3 tablets

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL -500 mg — Carton of Wallet

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 TabletsAlembic

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL — 500 mg — Blister foil

1 x 3 Tablets
Azithromycin
Tablets, USP 500 mg

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL — 500 mg — Mono Carton

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

1 x 3 tablets

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL -500 mg — Outer Carton of monocaton

NDC 62332-252-09

Azithromycin
Tablets, USP
500 mg
A full course of antibiotic therapy in 3 DAILY DOSES
3 Cartons x 3 Tablets
Rx onlyAlembic

AZITHROMYCIN azithromycin tablet, film coated

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:62332-252 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AZITHROMYCIN DIHYDRATE (AZITHROMYCIN ANHYDROUS) AZITHROMYCIN ANHYDROUS 500 mg

Inactive Ingredients Ingredient Name Strength ANHYDROUS DIBASIC CALCIUM PHOSPHATE CROSCARMELLOSE SODIUM HYDROXYPROPYL CELLULOSE (70000 WAMW) MAGNESIUM STEARATE SODIUM LAURYL SULFATE LACTOSE MONOHYDRATE HYPROMELLOSE 2910 (15 MPA.S) TITANIUM DIOXIDE D&C RED NO. 30 TRIACETIN

Product Characteristics Color PINK Score no score Shape CAPSULE Size 17mm Flavor Imprint Code 591;L Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:62332-252-30 30 TABLET, FILM COATED in 1 BOTTLE None 2 NDC:62332-252-03 3 BLISTER PACK in 1 CARTON contains a BLISTER PACK 2 3 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the CARTON (62332-252-03) 3 NDC:62332-252-09 3 BLISTER PACK in 1 CARTON contains a BLISTER PACK 3 3 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the CARTON (62332-252-09)

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	Operations
Alembic Pharmaceuticals Limited		650574671	MANUFACTURE (62332-252)

Revised: 01/2021 Alembic Pharmaceuticals Inc.