Pyrazinamide (Page 3 of 3)

PACKAGING INFORMATION

American Health Packaging unit dose blisters (see How Supplied section) contain drug product from Par Pharmaceutical as follows:
(500 mg / 100 UD) NDC 60687-138-01 packaged from NDC 67253-660

Distributed by:
American Health Packaging Columbus, OH 43217

8413801/0618

Package/Label Display Panel – Carton – 500 mg

500 mg Pyrazinamide Tablets Carton
(click image for full-size original)

NDC 60687- 138 -01

Pyrazinamide
Tablets, USP

500 mg

100 Tablets (10 x 10)              Rx Only

Usual Adult Dosage: 15-30 mg/kg once daily, not to
exceed 2 g. See package insert for full prescribing
information.

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 # 67253-660, Par Pharmaceutical.

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

713801 0413801/0419

Package/Label Display Panel – Blister – 500 mg

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

Pyrazinamide Tablet, USP

500 mg

PYRAZINAMIDE pyrazinamide tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:60687-138(NDC:67253-660)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PYRAZINAMIDE (PYRAZINAMIDE) PYRAZINAMIDE 500 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, CORN
MAGNESIUM STEARATE
STEARIC ACID
Product Characteristics
Color white Score 2 pieces
Shape ROUND Size 13mm
Flavor Imprint Code S;660
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:60687-138-01 100 BLISTER PACK in 1 BOX, UNIT-DOSE contains a BLISTER PACK (60687-138-11)
1 NDC:60687-138-11 1 TABLET in 1 BLISTER PACK This package is contained within the BOX, UNIT-DOSE (60687-138-01)
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 ANDA080157 10/24/2016 09/30/2021
Labeler — American Health Packaging (929561009)
Establishment
Name Address ID/FEI Operations
American Health Packaging 929561009 repack (60687-138)

Revised: 04/2020 American Health Packaging

Page 3 of 3 1 2 3

All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.

This site is provided for educational and informational purposes only, in accordance with our Terms of Use, and is not intended as a substitute for the advice of a medical doctor, nurse, nurse practitioner or other qualified health professional.

Privacy Policy | Copyright © 2020. All Rights Reserved.