Prescription Drug Information: Pyrazinamide (Page 2 of 2)

HOW SUPPLIED

Pyrazinamide Tablets, USP 500 mg are round, white, scored tablets, debossed S above the score, 660 below the score.
Unit dose packages of 100 (10 x 10) NDC 60687-138-01

Store at 20 to 25°C (68 to 77°F) [See USP Controlled Room Temperature].

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

REFERENCES

  1. Drug Information, American Hospital Formulary Service. American Society of Hospital Pharmacists. Bethesda, MD. 1991.
  2. USPDI, Drug Information for the Health Care Professional. United States Pharmacopeial Convention, Inc. Rockville, MD. 1991:1B:2226-2227.
  3. Goodman-Gilman A, Rall TW, Nies AS, Taylor P. The Pharmacological Basis of Therapeutics , ed 8. New York, Pergamon Press. 1990;1154.
  4. Treatment of tuberculosis and tuberculosis infection in adults and children. Am Rev Respir Dis. 1986;134:363-368.
  5. Reynolds JEF, Parfitt K, Parsons AV, Sweetman-SC. Martindale The Extra Pharmacopoeia , ed 29. London, The Pharmaceutical Press. 1989;569-570.
  6. Bioassay of pyrazinamide for possible carcinogenicity. National Cancer Institute Carcinogenesis Technical Report Series No. 48, 1978.
  7. Zerger E, Anderson B, Haworth S, Lawlor T, Mortelmans K, Speck W. Salmonella mutagenicity tests: III. Results from the testing of 255 chemicals. Environ Mutagen. 1987;9 (Suppl 9):1-109.
  8. Roman IC, Georgian L. Cytogenetic effects of some antituberculosis drugs in vitro. Mutation Research. 1977;48:215-224.
  9. Holdiness M. Antituberculosis drugs and breast-feeding. Arch Intern Med. 1984;144:1888.
  10. Turcios N, Evans H. Preventing and managing tuberculosis in children. J Resp Dis. 1989;10(6)(Jun):23.
  11. Starke JR. Multidrug therapy for tuberculosis in children. Pediatr Infec Dis J. 1990;9:785-793.
  12. Specific requirements on content and format of labeling for human prescription drugs; proposed addition of “geriatric use” subsection in the labeling. Federal Register. 1990;55(212)(Nov 1):46134-46137.
  13. Stamathakis G, Montes C, Trouvin JH, et al. Pyrazinamide and pyrazinoic acid pharmacokinetics in patients with chronic renal failure. Clinical Nephrology. 1988;30:230-234.

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

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