Metronidazole tablet

Laboratory tests



Pregnancy

Teratogenic Effects


Pregnancy category B

Use of metronidazole for trichomoniasis during pregnancy should be restricted to those in whom alternative treatment has been inadequate. Use of metronidazole for trichomoniasis in the first trimester of pregnancy should be carefully evaluated because metronidazole crosses the placental barrier and its effects on the human fetal organogenesis are not known (see above).

Ingredients and appearance - Product information

Metronidazole tablet- Metronidazole

Product information

Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC: 49349-164
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
Silicon dioxide ( UNII: ETJ7Z6XBU4)
Crospovidone ( UNII: 68401960MK)
Cellulose, microcrystalline ( UNII: OP1R32D61U)

Product Characteristics

Color white Score 2
Shape OVAL (TABLET) Imprint Code 93;93;852
Size 17 mm

Packaging

# Item Code Package Description Marketing Start Date
1 NDC: 49349-164-17 4 in 1 BLISTER PACK 2011/04/13

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
ANDA ANDA070044 USA 2011/04/13

Labeler - REMEDYREPACK INC.( 829572556)