metronidazole

Generic: metronidazole

Labeler: northstar rx llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name metronidazole
Generic Name metronidazole
Labeler northstar rx llc
Dosage Form GEL
Routes
VAGINAL
Active Ingredients

metronidazole 7.5 mg/g

Manufacturer
Northstar Rx LLC

Identifiers & Regulatory

Product NDC 16714-557
Product ID 16714-557_d7cc0dfd-2d83-45ac-aef7-d8f5be09238d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA215794
Listing Expiration 2026-12-31
Marketing Start 2022-06-24

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 16714557
Hyphenated Format 16714-557

Supplemental Identifiers

RxCUI
142046
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 (16714-557-01) / 70 g in 1 TUBE, WITH APPLICATOR
source: ndc

Packages (1)

16714-557-01 1 TUBE, WITH APPLICATOR in 1 CARTON (16714-557-01) / 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": "d7cc0dfd-2d83-45ac-aef7-d8f5be09238d", "openfda": {"nui": ["N0000175435", "M0014907"], "unii": ["140QMO216E"], "rxcui": ["142046"], "spl_set_id": ["65cda174-d840-488a-96d0-74d6086b7048"], "pharm_class_cs": ["Nitroimidazoles [CS]"], "pharm_class_epc": ["Nitroimidazole Antimicrobial [EPC]"], "manufacturer_name": ["Northstar Rx LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE, WITH APPLICATOR in 1 CARTON (16714-557-01)  / 70 g in 1 TUBE, WITH APPLICATOR", "package_ndc": "16714-557-01", "marketing_start_date": "20220624"}], "brand_name": "Metronidazole", "product_id": "16714-557_d7cc0dfd-2d83-45ac-aef7-d8f5be09238d", "dosage_form": "GEL", "pharm_class": ["Nitroimidazole Antimicrobial [EPC]", "Nitroimidazoles [CS]"], "product_ndc": "16714-557", "generic_name": "Metronidazole", "labeler_name": "Northstar Rx LLC", "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": "20220624", "listing_expiration_date": "20261231"}