NDC Code(s) : 68084-906-11, 68084-906-01, 68084-913-33, 68084-913-32
Packager : American Health Packaging

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

AzithromycinAzithromycin TABLET, FILM COATED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68084-906(NDC:0093-7146)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AZITHROMYCIN MONOHYDRATE(UNII: JTE4MNN1MD)
(AZITHROMYCIN ANHYDROUS - UNII:J2KLZ20U1M) 		AZITHROMYCIN ANHYDROUS250 mg
Inactive Ingredients
Ingredient Name Strength
BUTYLATED HYDROXYTOLUENE(UNII: 1P9D0Z171K)
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS(UNII: L11K75P92J)
PIGMENT RED 5(UNII: 91OZU993LX)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
FD&C RED NO. 40(UNII: WZB9127XOA)
FD&C YELLOW NO. 6(UNII: H77VEI93A8)
HYPROMELLOSE 2910 (15 MPA.S)(UNII: 36SFW2JZ0W)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE(UNII: 70097M6I30)
STARCH, CORN(UNII: O8232NY3SJ)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
TALC(UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
TRIACETIN(UNII: XHX3C3X673)
Product Characteristics
Color pink (mottled pink) Score no score
Shape OVAL Size 14 mm
Flavor Imprint Code 93;7146
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:68084-906-01100 in 1 BOX, UNIT-DOSE
1NDC:68084-906-111 in 1 BLISTER PACK Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA065153 01/15/2015 06/30/2016
AzithromycinAzithromycin TABLET, FILM COATED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68084-913(NDC:0093-7169)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AZITHROMYCIN MONOHYDRATE(UNII: JTE4MNN1MD)
(AZITHROMYCIN ANHYDROUS - UNII:J2KLZ20U1M) 		AZITHROMYCIN ANHYDROUS500 mg
Inactive Ingredients
Ingredient Name Strength
BUTYLATED HYDROXYTOLUENE(UNII: 1P9D0Z171K)
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS(UNII: L11K75P92J)
PIGMENT RED 5(UNII: 91OZU993LX)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
FD&C RED NO. 40(UNII: WZB9127XOA)
FD&C YELLOW NO. 6(UNII: H77VEI93A8)
HYPROMELLOSE 2910 (15 MPA.S)(UNII: 36SFW2JZ0W)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE(UNII: 70097M6I30)
STARCH, CORN(UNII: O8232NY3SJ)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
TALC(UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
TRIACETIN(UNII: XHX3C3X673)
Product Characteristics
Color pink (mottled pink) Score no score
Shape OVAL Size 18 mm
Flavor Imprint Code 93;7169
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:68084-913-3220 in 1 BOX, UNIT-DOSE
1NDC:68084-913-331 in 1 BLISTER PACK Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA065193 01/15/2015 10/31/2016

PRINCIPAL DISPLAY PANEL

Azithromycin 250 mg Label

NDC 68084-906-01

AZITHROMYCIN
Tablets USP

250 mg

100 Tablets (10 × 10)

PHARMACIST: Dispense with the accompanying
Patient Information Leaflet to each patient.

Each tablet contains azithromycin monohydrate, USP
equivalent to 250 mg of azithromycin.

Usual Dosage: See package insert for full
prescribing information.

Can be taken with or without food.

Store at 20º to 25ºC (68º to 77ºF) excursions
permitted to 15º to 30ºC (59º to 86ºF) [see USP
Controlled Room Temperature].

Keep this and all drugs out of reach of children.

Rx Only

The drug product contained in this package is from
NDC # 0093-7146, Teva Pharmaceuticals USA Inc.

Packaged and Distributed by:
American Health Packaging
Columbus, Ohio 43217

090601
Rev. 11/2014

PRINCIPAL DISPLAY PANEL

Azithromycin 500 mg Label

NDC 68084-913-32

AZITHROMYCIN
Tablets USP

500 mg

20 Tablets (5 × 4)

PHARMACIST: Dispense with the accompanying
Patient Information Leaflet to each patient.

Each tablet contains azithromycin monohydrate, USP
equivalent to 500 mg of azithromycin.

Usual Dosage: See package insert for full
prescribing information.

Can be taken with or without food.

Store at 20º to 25ºC (68º to 77ºF); excursions
permitted to 15º to 30ºC (59º to 86ºF) [see USP
Controlled Room Temperature].

Keep this and all drugs out of reach of children.

Rx Only

The drug product contained in this package is from
NDC # 0093-7169, Teva Pharmaceuticals USA Inc.

Packaged and Distributed by:
American Health Packaging
Columbus, Ohio 43217

091332
Rev. 11/2014