Azithromycin Monohydrate (Page 8 of 8)

Package/Label Display Panel – Carton – 250 mg – 50 UD

250 mg Azithromycin Tablets Carton (50UD)
(click image for full-size original)

NDC 60687- 282 -65

Azithromycin
Tablets USP

250 mg

50 Tablets (5 x 10)               Rx Only

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

Each Film-Coated Tablet Contains:
Azithromycin monohydrate USP equivalent to 250 mg of
azithromycin USP.

Usual Dosage: See package insert for full prescribing information.
Can be taken with or without food.

Store at 20° to 25°C (68° to 77°F); excursions permitted between
15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

Keep this and all drugs out of reach of children.

FOR YOUR PROTECTION: Do not use if blister is torn or broken.

The drug product contained in this package is from
NDC # 68180-160, Lupin Pharmaceuticals, Inc.

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

728265 0428265/1019

Package/Label Display Panel – Carton – 250 mg – 100 UD

250 mg Azithromycin Tablets Carton (100UD)
(click image for full-size original)

NDC 60687- 282 -01

Azithromycin
Tablets USP

250 mg

100 Tablets (10 x 10)                Rx Only

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

Each Film-Coated Tablet Contains:
Azithromycin monohydrate USP equivalent to 250 mg of
azithromycin USP.

Usual Dosage: See package insert for full prescribing
information. Can be taken with or without food.

Store at 20° to 25°C (68° to 77°F); excursions permitted
between 15° to 30°C (59° to 86°F) [see USP Controlled
Room Temperature].

Keep this and all drugs out of reach of children.

FOR YOUR PROTECTION: Do not use if blister is torn or
broken.

The drug product contained in this package is from
NDC # 68180-160, Lupin Pharmaceuticals, Inc.

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

728201 0428201/1218

Package/Label Display Panel – Blister – 250 mg

250 mg Azithromycin Tablet Blister
(click image for full-size original)

Azithromycin Tablet USP

250 mg

Package/Label Display Panel – Carton – 500 mg

500 mg Azithromycin Tablets Carton (30UD)
(click image for full-size original)

NDC 60687- 271 -21

Azithromycin
Tablets USP

500 mg

30 Tablets (3 x 10)                Rx Only

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

Each Film-Coated Tablet Contains:
Azithromycin monohydrate USP equivalent to 500 mg of
azithromycin USP.

Usual Dosage: See package insert for full prescribing
information. Can be taken with or without food.

Store at 20° to 25°C (68° to 77°F); excursions permitted between
15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

Keep this and all drugs out of reach of children.

FOR YOUR PROTECTION: Do not use if blister is torn or broken.

The drug product contained in this package is from
NDC # 68180-161, Lupin Pharmaceuticals, Inc.

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

727122 0427121/1218

Package/Label Display Panel – Blister – 500 mg

500 mg Azithromycin Tablet Blister
(click image for full-size original)

Azithromycin Tablet USP

500 mg

AZITHROMYCIN MONOHYDRATE azithromycin monohydrate tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:60687-282(NDC:68180-160)
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
CROSCARMELLOSE SODIUM
ANHYDROUS DIBASIC CALCIUM PHOSPHATE
HYPROMELLOSE 2910 (15 MPA.S)
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
SODIUM LAURYL SULFATE
TITANIUM DIOXIDE
TRIACETIN
D&C RED NO. 30
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:60687-282-65 50 BLISTER PACK in 1 BOX, UNIT-DOSE contains a BLISTER PACK (60687-282-11)
1 NDC:60687-282-11 1 TABLET in 1 BLISTER PACK This package is contained within the BOX, UNIT-DOSE (60687-282-65)
2 NDC:60687-282-01 100 BLISTER PACK in 1 BOX, UNIT-DOSE contains a BLISTER PACK (60687-282-11)
2 NDC:60687-282-11 1 TABLET in 1 BLISTER PACK This package is contained within the BOX, UNIT-DOSE (60687-282-01)
Image of Product
(click image for full-size original)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA065398 02/13/2017
AZITHROMYCIN MONOHYDRATE azithromycin monohydrate tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:60687-271(NDC:68180-161)
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
CROSCARMELLOSE SODIUM
ANHYDROUS DIBASIC CALCIUM PHOSPHATE
HYPROMELLOSE 2910 (15 MPA.S)
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
SODIUM LAURYL SULFATE
TITANIUM DIOXIDE
TRIACETIN
D&C RED NO. 30
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:60687-271-21 30 BLISTER PACK in 1 BOX, UNIT-DOSE contains a BLISTER PACK (60687-271-11)
1 NDC:60687-271-11 1 TABLET in 1 BLISTER PACK This package is contained within the BOX, UNIT-DOSE (60687-271-21)
Image of Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA065399 01/24/2017
Labeler — American Health Packaging (929561009)
Establishment
Name Address ID/FEI Operations
American Health Packaging 929561009 repack (60687-282), repack (60687-271)

Revised: 11/2019 American Health Packaging

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