metronidazole

Generic: metronidazole

Labeler: glenmark pharmaceuticals inc., usa
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name metronidazole
Generic Name metronidazole
Labeler glenmark pharmaceuticals inc., usa
Dosage Form GEL
Routes
VAGINAL
Active Ingredients

metronidazole 7.5 mg/g

Manufacturer
GLENMARK PHARMACEUTICALS INC., USA

Identifiers & Regulatory

Product NDC 68462-184
Product ID 68462-184_ee3d1458-acf8-4171-b1ec-25e2807bd6f9
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA215794
Listing Expiration 2027-12-31
Marketing Start 2022-01-27

Pharmacologic Class

Established (EPC)
nitroimidazole antimicrobial [epc]
Chemical Structure
nitroimidazoles [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68462184
Hyphenated Format 68462-184

Supplemental Identifiers

RxCUI
142046
UPC
0368462184493
UNII
140QMO216E
NUI
N0000175435 M0014907

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name metronidazole (source: ndc)
Generic Name metronidazole (source: ndc)
Application Number ANDA215794 (source: ndc)
Routes
VAGINAL
source: ndc

Resolved Composition

Strengths
  • 7.5 mg/g
source: ndc
Packaging
  • 1 TUBE, WITH APPLICATOR in 1 CARTON (68462-184-49) / 70 g in 1 TUBE, WITH APPLICATOR
source: ndc

Packages (1)

68462-184-49 1 TUBE, WITH APPLICATOR in 1 CARTON (68462-184-49) / 70 g in 1 TUBE, WITH APPLICATOR

Ingredients (1)

metronidazole (7.5 mg/g)

Linked Drug Pages (1)

Metronidazole ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["VAGINAL"], "spl_id": "ee3d1458-acf8-4171-b1ec-25e2807bd6f9", "openfda": {"nui": ["N0000175435", "M0014907"], "upc": ["0368462184493"], "unii": ["140QMO216E"], "rxcui": ["142046"], "spl_set_id": ["6736c100-a7fe-44ea-8579-5537537ff9b8"], "pharm_class_cs": ["Nitroimidazoles [CS]"], "pharm_class_epc": ["Nitroimidazole Antimicrobial [EPC]"], "manufacturer_name": ["GLENMARK PHARMACEUTICALS INC., USA"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE, WITH APPLICATOR in 1 CARTON (68462-184-49)  / 70 g in 1 TUBE, WITH APPLICATOR", "package_ndc": "68462-184-49", "marketing_start_date": "20220127"}], "brand_name": "Metronidazole", "product_id": "68462-184_ee3d1458-acf8-4171-b1ec-25e2807bd6f9", "dosage_form": "GEL", "pharm_class": ["Nitroimidazole Antimicrobial [EPC]", "Nitroimidazoles [CS]"], "product_ndc": "68462-184", "generic_name": "Metronidazole", "labeler_name": "GLENMARK PHARMACEUTICALS INC., USA", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Metronidazole", "active_ingredients": [{"name": "METRONIDAZOLE", "strength": "7.5 mg/g"}], "application_number": "ANDA215794", "marketing_category": "ANDA", "marketing_start_date": "20220127", "listing_expiration_date": "20271231"}