metronidazole vaginal

Basic Information

Product Name

FDA Product Code

45802-139

Regulatory Information

NDC Product Code

45802-139

Application Number

ANDA211786

Marketing Category

C73584

Effective Date

June 10, 2019

Territorial Authority

USA

FDA Title

Metronidazole Vaginal Gel, 0.75%

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Version Number

Active Ingredients

PROPYLPARABEN

Code: Z8IX2SC1OH

Class Code: IACT

METRONIDAZOLE

Quantity: 7.5 mg in 1 g

Code: 140QMO216E

Class Code: ACTIB

WATER

Code: 059QF0KO0R

Class Code: IACT

PROPYLENE GLYCOL

Code: 6DC9Q167V3

Class Code: IACT

EDETATE DISODIUM

Code: 7FLD91C86K

Class Code: IACT

CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)

Code: HHT01ZNK31

Class Code: IACT

SODIUM HYDROXIDE

Code: 55X04QC32I

Class Code: IACT

METHYLPARABEN

Code: A2I8C7HI9T

Class Code: IACT

Active Moieties

METRONIDAZOLE

Code: 140QMO216E

Basic Information

Regulatory Information

Company Information

Active Ingredients

PROPYLPARABEN

WATER

PROPYLENE GLYCOL

EDETATE DISODIUM

CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)

SODIUM HYDROXIDE

METHYLPARABEN

Active Moieties

METRONIDAZOLE