Metronidazole (Page 4 of 4)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL — 250 mg

250mg
(click image for full-size original)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL — 500 mg

500mg
(click image for full-size original)

METRONIDAZOLE
metronidazole tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50268-534(NDC:62332-016)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
METRONIDAZOLE (METRONIDAZOLE) METRONIDAZOLE 250 mg
Inactive Ingredients
Ingredient Name Strength
CROSPOVIDONE
HYDROXYPROPYL CELLULOSE (70000 WAMW)
CELLULOSE, MICROCRYSTALLINE
SILICON DIOXIDE
HYDROGENATED COTTONSEED OIL
Product Characteristics
Color white (white to off white) Score no score
Shape ROUND (circular, biconvex) Size 9mm
Flavor Imprint Code HP64
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:50268-534-15 50 BLISTER PACK in 1 BOX contains a BLISTER PACK (50268-534-11)
1 NDC:50268-534-11 1 TABLET in 1 BLISTER PACK This package is contained within the BOX (50268-534-15)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA079067 10/30/2019
METRONIDAZOLE
metronidazole tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50268-535(NDC:62332-017)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
METRONIDAZOLE (METRONIDAZOLE) METRONIDAZOLE 500 mg
Inactive Ingredients
Ingredient Name Strength
CROSPOVIDONE
HYDROXYPROPYL CELLULOSE (70000 WAMW)
CELLULOSE, MICROCRYSTALLINE
SILICON DIOXIDE
HYDROGENATED COTTONSEED OIL
Product Characteristics
Color white (white to off white) Score no score
Shape CAPSULE (oblong, biconvex) Size 16mm
Flavor Imprint Code HP65
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:50268-535-15 50 BLISTER PACK in 1 BOX contains a BLISTER PACK (50268-535-11)
1 NDC:50268-535-11 1 TABLET in 1 BLISTER PACK This package is contained within the BOX (50268-535-15)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA079067 10/30/2019
Labeler — AvPAK (832926666)

Revised: 05/2022 AvPAK

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