Azithromycin Monohydrate (Page 8 of 8)

​PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Azithromycin Tablets USP, 250 mg

Container Label-30 Tablets

NDC 68180-160-06

Azithromycin Tablets USP, 250 mg

3 Card x 6 Tablets- Outer Carton Label

NDC 68180-160-13

Azithromycin Tablets USP, 250 mg

6 Tablets- Blister Card

NDC 68180-160-11

Azithromycin Tablets USP, 500 mg

Container Label-30 Tablets

NDC 68180-161-06

Azithromycin Tablets USP, 500 mg

3 Card x 3 Tablets- Outer Carton Label

NDC 68180-161-13

Azithromycin Tablets USP, 500 mg

3 Tablets- Blister Card

NDC 68180-161-11

AZITHROMYCIN MONOHYDRATE azithromycin monohydrate tablet

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:57297-160 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AZITHROMYCIN MONOHYDRATE (AZITHROMYCIN ANHYDROUS) AZITHROMYCIN ANHYDROUS 250 mg

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

Product Characteristics Color PINK Score no score Shape OVAL Size 14mm Flavor Imprint Code LU;L11 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:57297-160-06 30 TABLET in 1 CONTAINER None 2 NDC:57297-160-13 3 BLISTER PACK in 1 CARTON contains a BLISTER PACK 2 6 TABLET in 1 BLISTER PACK This package is contained within the CARTON (57297-160-13)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA065398 07/22/2015

AZITHROMYCIN MONOHYDRATE azithromycin monohydrate tablet

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:57297-161 Route of Administration ORAL DEA Schedule

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

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

Product Characteristics Color PINK Score no score Shape OVAL Size 17mm Flavor Imprint Code LU;L12 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:57297-161-06 30 TABLET in 1 CONTAINER None 2 NDC:57297-161-13 3 BLISTER PACK in 1 CARTON contains a BLISTER PACK 2 3 TABLET in 1 BLISTER PACK This package is contained within the CARTON (57297-161-13)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA065399 07/22/2015

Labeler — LUPIN LIMITED (675923163)

Registrant — LUPIN LIMITED (675923163)

Establishment
Name	Address	ID/FEI	Operations
LUPIN LIMITED		677600414	manufacture (57297-160), manufacture (57297-161), pack (57297-160), pack (57297-161)

Revised: 02/2016 LUPIN LIMITED