Prescription Drug Information: Pyrazinamide (Page 2 of 2)

HOW SUPPLIED:

Pyrazinamide Tablets USP contain pyrazinamide 500 mg. They are supplied as white, round, scored tablets, debossed “VP/012″ in containers of 60 tablets, NDC# 61748-012-06, in containers of 90 tablets, NDC# 61748-012-09, in containers of 100 tablets, NDC# 61748-012-01, in containers of 500 tablets, NDC# 61748-012-05, and in hospital unit-dose cartons of 100 tablets (in strips of 10 tablets per strip), NDC# 61748-012-11.

Storage: Store in a well-closed container at controlled room temperature 15°C to 30°C (59°F to 86°F).

Dispense in a well-closed container with a child resistant closure.


Rx only

Manufactured for:

VersaPharm Inc. – An Akorn Company

Lake Forest, IL 60045
Manufactured by:

MIKART, INC.

Atlanta, GA 30318

Rev. 09/16

Code 590B00

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: 1 B : 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) : 1109.

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: 785793.

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.

Twice Weekly Dose

DRUG: Pyrazinamide

GENERIC: Pyrazinamide

DOSAGE: TABLET

ADMINSTRATION: ORAL

NDC: 70518-2534-0

COLOR: white

SHAPE: ROUND

SCORE: Two even pieces

SIZE: 13 mm

IMPRINT: VP;012

PACKAGING: 30 in 1 BLISTER PACK

ACTIVE INGREDIENT(S):

  • PYRAZINAMIDE 500mg in 1

INACTIVE INGREDIENT(S):

  • DIBASIC CALCIUM PHOSPHATE DIHYDRATE
  • MICROCRYSTALLINE CELLULOSE
  • SILICON DIOXIDE
  • CROSCARMELLOSE SODIUM
  • STEARIC ACID
Remedy_Label
(click image for full-size original)
PYRAZINAMIDE
pyrazinamide tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70518-2534(NDC:61748-012)
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
SILICON DIOXIDE
CROSCARMELLOSE SODIUM
DIBASIC CALCIUM PHOSPHATE DIHYDRATE
MICROCRYSTALLINE CELLULOSE
STEARIC ACID
Product Characteristics
Color white (WHITE) Score 2 pieces
Shape ROUND (ROUND) Size 13mm
Flavor Imprint Code VP;012
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70518-2534-0 30 TABLET in 1 BLISTER PACK None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA081319 01/10/2020
Labeler — REMEDYREPACK INC. (829572556)

Revised: 01/2020 REMEDYREPACK INC.

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