NDC Code(s) : 62332-251-30, 62332-251-06, 62332-251-18
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:62332-251
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)
HYDROXYPROPYL CELLULOSE (TYPE E)(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 13 mm
Flavor Imprint Code 590;L
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:62332-251-3030 in 1 BOTTLE Type 0: Not a Combination Product29/01/2020
2NDC:62332-251-0618 in 1 CARTON 29/01/2020
26 in 1 BLISTER PACK Type 0: Not a Combination Product29/01/2020
3NDC:62332-251-1818 in 1 CARTON 29/01/2020
36 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 ANDA211791 01/29/2020

LABELER - Alembic Pharmaceuticals Inc.(079288842)

Establishment
Name Address ID/FEI Business Operations
Alembic Pharmaceuticals Limited 650574671 MANUFACTURE(62332-251)

PRINCIPAL DISPLAY PANEL

NDC 62332-251-30
Azithromycin
Tablets, USP
250 mg
Rx only
30 Tablets
Alembic

azithromycin-bl-250mg


PRINCIPAL DISPLAY PANEL

NDC 62332-251-06
Azithromycin Tablets, USP
250 mg
A full course of antibiotic therapy in 5 DAILY DOSES
Rx only
1 Card x 6 Tablets
Alembic
azithromycin-250mg-wallet

PRINCIPAL DISPLAY PANEL

NDC 62332-251-06

Azithromycin Tablets, USP
250 mg

 A full course of antibiotic therapy in 5 DAILY DOSES
Rx only
Alembic
3 Cards x 6 Tablets

azithromycin-250mg-ct

PRINCIPAL DISPLAY PANEL

Azithromycin Tablets,
USP 250 mg
1 x 6 Tablets

blister foil

  

 

PRINCIPAL DISPLAY PANEL

NDC 62332-251-18
6 tablets per blister
per monocarton
Azithromycin Tablets, USP
250 mg
A full course of antibiotic therapy in 5 DAILY DOSES
Rx only
Alembic

6 tablets per blister per monocarton

 

PRINCIPAL DISPLAY PANEL

Azithromycin Tablets, USP
250 mg
A full course of antibiotic therapy in 5 DAILY DOSES
3 monocartons (6 tablets per blister per monocarton)
Rx only
Alembic

3 monocartons (6 tablets per blister per monocarton)