NDC Code(s) : 43063-620-04, 43063-620-14
Packager : PD-Rx Pharmaceuticals, Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

MetronidazoleMetronidazole TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:43063-620(NDC:23155-065)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
METRONIDAZOLE(UNII: 140QMO216E)
(METRONIDAZOLE - UNII:140QMO216E) 		METRONIDAZOLE500 mg
Inactive Ingredients
Ingredient Name Strength
HYDROXYPROPYL CELLULOSE (TYPE E)(UNII: 66O7AQV0RT)
CROSPOVIDONE(UNII: 68401960MK)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
HYDROGENATED COTTONSEED OIL(UNII: Z82Y2C65EA)
Product Characteristics
Color white (white to off white) Score no score
Shape CAPSULE (oblong, biconvex) Size 16 mm
Flavor Imprint Code HP65
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:43063-620-044 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product21/09/2015
2NDC:43063-620-1414 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product29/09/2015
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA079067 12/16/2013

PRINCIPAL DISPLAY PANEL

43063620 Label