Metronidazole tablet

Ingredients and appearance - Product information

Metronidazole tablet- Metronidazole

Product information

Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC: 63629-6379
Route of Administration Oral

Active Ingredient/Active Moiety

Ingredient Name Strength
Metronidazole ( UNII: 140QMO216E)( Metronidazole - UNII: 140QMO216E ) 500 mgin 1

Inactive Ingredients

Ingredient Name Code
Microcrystalline cellulose ( UNII: OP1R32D61U)
Crospovidone (15 mpa.s at 5%) ( UNII: 68401960MK)
Silicon dioxide ( UNII: ETJ7Z6XBU4)
Hydrogenated cottonseed oil ( UNII: Z82Y2C65EA)

Product Characteristics

Color WHITE Size 16 mm
Shape OVAL (oblong) Score 1
Imprint Code PLIVA;334

Packaging

# Item Code Package Description Marketing Start Date
1 NDC: 63629-6379-1 24 in 1 BOTTLE 2015/09/17
2 NDC: 63629-6379-2 14 in 1 BOTTLE 2015/08/28
3 NDC: 63629-6379-3 40 in 1 BOTTLE 2015/08/28
4 NDC: 63629-6379-4 4 in 1 BOTTLE 2016/02/23
5 NDC: 63629-6379-5 30 in 1 BOTTLE 2016/04/28
6 NDC: 63629-6379-6 21 in 1 BOTTLE 2017/02/15
7 NDC: 63629-6379-7 10 in 1 BOTTLE 2016/12/30
8 NDC: 63629-6379-8 20 in 1 BOTTLE 2016/12/30
9 NDC: 63629-6379-9 28 in 1 BOTTLE 2015/08/28

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
ANDA ANDA070033 USA 2015/08/28

Metronidazole tablet- Metronidazole

Product information

Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC: 63629-7754
Route of Administration Oral

Active Ingredient/Active Moiety

Ingredient Name Strength
Metronidazole ( UNII: 140QMO216E)( Metronidazole - UNII: 140QMO216E ) 250 mgin 1

Inactive Ingredients

Ingredient Name Code
Microcrystalline cellulose ( UNII: OP1R32D61U)
Crospovidone (15 mpa.s at 5%) ( UNII: 68401960MK)
Silicon dioxide ( UNII: ETJ7Z6XBU4)
Hydrogenated cottonseed oil ( UNII: Z82Y2C65EA)

Product Characteristics

Color WHITE Imprint Code PLIVA;333
Score 1 Shape ROUND
Size 9 mm

Packaging

# Item Code Package Description Marketing Start Date
1 NDC: 63629-7754-1 28 in 1 BOTTLE 2005/11/09
2 NDC: 63629-7754-2 8 in 1 BOTTLE 2005/11/09
3 NDC: 63629-7754-3 14 in 1 BOTTLE 2005/11/09
4 NDC: 63629-7754-4 21 in 1 BOTTLE 2005/11/09
5 NDC: 63629-7754-5 30 in 1 BOTTLE 2005/11/09
6 NDC: 63629-7754-6 300 in 1 BOTTLE 2005/11/09

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
ANDA ANDA070027 USA 2005/11/09

Labeler - Bryant Ranch Prepack( 171714327)

Establishment

Name ID/FEI Business Operations
Bryant Ranch Prepack 171714327 REPACK( 63629-7754, 63629-6379), RELABEL( 63629-6379, 63629-7754)

Metronidazole tablet

Metronidazole 250mg tab

Agar dilution method is recommended for all anaerobes
Broth dilution method is recommended for testing of Bacteroides fragilis group only; for this group, MIC values by agar and broth dilution methods are considered equivalent