metronidazole

Generic: metronidazole

Labeler: alembic pharmaceuticals limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name metronidazole
Generic Name metronidazole
Labeler alembic pharmaceuticals limited
Dosage Form GEL
Routes
TOPICAL
Active Ingredients

metronidazole 10 mg/g

Manufacturer
Alembic Pharmaceuticals Limited

Identifiers & Regulatory

Product NDC 46708-630
Product ID 46708-630_ccb6c97f-34f9-4aeb-81ba-824a9b8a0ecd
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA212646
Listing Expiration 2026-12-31
Marketing Start 2025-03-17

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 46708630
Hyphenated Format 46708-630

Supplemental Identifiers

RxCUI
577237
UPC
0346708630607
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 ANDA212646 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/g
source: ndc
Packaging
  • 1 TUBE in 1 CARTON (46708-630-45) / 45 g in 1 TUBE
  • 1 BOTTLE, PUMP in 1 CARTON (46708-630-55) / 55 g in 1 BOTTLE, PUMP
  • 1 TUBE in 1 CARTON (46708-630-60) / 60 g in 1 TUBE
source: ndc

Packages (3)

46708-630-45 1 TUBE in 1 CARTON (46708-630-45) / 45 g in 1 TUBE 46708-630-55 1 BOTTLE, PUMP in 1 CARTON (46708-630-55) / 55 g in 1 BOTTLE, PUMP 46708-630-60 1 TUBE in 1 CARTON (46708-630-60) / 60 g in 1 TUBE

Ingredients (1)

metronidazole (10 mg/g)

Linked Drug Pages (1)

Metronidazole ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "ccb6c97f-34f9-4aeb-81ba-824a9b8a0ecd", "openfda": {"nui": ["N0000175435", "M0014907"], "upc": ["0346708630607"], "unii": ["140QMO216E"], "rxcui": ["577237"], "spl_set_id": ["e43b880b-ce69-4f56-9c1c-9c7ca23bba84"], "pharm_class_cs": ["Nitroimidazoles [CS]"], "pharm_class_epc": ["Nitroimidazole Antimicrobial [EPC]"], "manufacturer_name": ["Alembic Pharmaceuticals Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 CARTON (46708-630-45)  / 45 g in 1 TUBE", "package_ndc": "46708-630-45", "marketing_start_date": "20250317"}, {"sample": false, "description": "1 BOTTLE, PUMP in 1 CARTON (46708-630-55)  / 55 g in 1 BOTTLE, PUMP", "package_ndc": "46708-630-55", "marketing_start_date": "20250317"}, {"sample": false, "description": "1 TUBE in 1 CARTON (46708-630-60)  / 60 g in 1 TUBE", "package_ndc": "46708-630-60", "marketing_start_date": "20250317"}], "brand_name": "Metronidazole", "product_id": "46708-630_ccb6c97f-34f9-4aeb-81ba-824a9b8a0ecd", "dosage_form": "GEL", "pharm_class": ["Nitroimidazole Antimicrobial [EPC]", "Nitroimidazoles [CS]"], "product_ndc": "46708-630", "generic_name": "Metronidazole", "labeler_name": "Alembic Pharmaceuticals Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Metronidazole", "active_ingredients": [{"name": "METRONIDAZOLE", "strength": "10 mg/g"}], "application_number": "ANDA212646", "marketing_category": "ANDA", "marketing_start_date": "20250317", "listing_expiration_date": "20261231"}