NDC Code(s) : 52125-013-02
Packager : REMEDYREPACK INC.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

PyrazinamidePyrazinamide TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:52125-013(NDC:61748-012)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PYRAZINAMIDE(UNII: 2KNI5N06TI)
(PYRAZINAMIDE - UNII:2KNI5N06TI) 		PYRAZINAMIDE500 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
CROSCARMELLOSE SODIUM(UNII: M28OL1HH48)
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE(UNII: O7TSZ97GEP)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
STEARIC ACID(UNII: 4ELV7Z65AP)
Product Characteristics
Color white Score 2 pieces
Shape ROUND (TABLET) Size 13 mm
Flavor Imprint Code VP;012
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:52125-013-0230 in 1 BLISTER PACK Type 0: Not a Combination Product26/02/2013
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA081319 02/26/2013 02/27/2014

PRINCIPAL DISPLAY PANEL

DRUG: Pyrazinamide

GENERIC: Pyrazinamide

DOSAGE: TABLET

ADMINSTRATION: ORAL

NDC: 52125-013-02

STRENGTH:500 mg

COLOR: white

SHAPE: ROUND

SCORE: Two even pieces

SIZE: 13 mm

IMPRINT: 30

QTY: 30



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