metronidazole

Generic: metronidazole

Labeler: remedyrepack inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name metronidazole
Generic Name metronidazole
Labeler remedyrepack inc.
Dosage Form GEL
Routes
VAGINAL
Active Ingredients

metronidazole 7.5 mg/g

Manufacturer
REMEDYREPACK INC.

Identifiers & Regulatory

Product NDC 70518-4495
Product ID 70518-4495_40cf73ed-a984-ec03-e063-6294a90a4e93
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA213648
Listing Expiration 2026-12-31
Marketing Start 2025-10-10

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 705184495
Hyphenated Format 70518-4495

Supplemental Identifiers

RxCUI
142046
UNII
140QMO216E
NUI
N0000175435 M0014907

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 ANDA213648 (source: ndc)
Routes
VAGINAL
source: ndc

Resolved Composition

Strengths
  • 7.5 mg/g
source: ndc
Packaging
  • 1 TUBE, WITH APPLICATOR in 1 CARTON (70518-4495-0) / 70 g in 1 TUBE, WITH APPLICATOR
source: ndc

Packages (1)

70518-4495-0 1 TUBE, WITH APPLICATOR in 1 CARTON (70518-4495-0) / 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": "40cf73ed-a984-ec03-e063-6294a90a4e93", "openfda": {"nui": ["N0000175435", "M0014907"], "unii": ["140QMO216E"], "rxcui": ["142046"], "spl_set_id": ["2a6f8d77-a5b7-40fb-9a2e-e2778c39ba01"], "pharm_class_cs": ["Nitroimidazoles [CS]"], "pharm_class_epc": ["Nitroimidazole Antimicrobial [EPC]"], "manufacturer_name": ["REMEDYREPACK INC."]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE, WITH APPLICATOR in 1 CARTON (70518-4495-0)  / 70 g in 1 TUBE, WITH APPLICATOR", "package_ndc": "70518-4495-0", "marketing_start_date": "20251010"}], "brand_name": "Metronidazole", "product_id": "70518-4495_40cf73ed-a984-ec03-e063-6294a90a4e93", "dosage_form": "GEL", "pharm_class": ["Nitroimidazole Antimicrobial [EPC]", "Nitroimidazoles [CS]"], "product_ndc": "70518-4495", "generic_name": "Metronidazole", "labeler_name": "REMEDYREPACK INC.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Metronidazole", "active_ingredients": [{"name": "METRONIDAZOLE", "strength": "7.5 mg/g"}], "application_number": "ANDA213648", "marketing_category": "ANDA", "marketing_start_date": "20251010", "listing_expiration_date": "20261231"}