metronidazole

Generic: metronidazole

Labeler: fougera pharmaceuticals, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name metronidazole
Generic Name metronidazole
Labeler fougera pharmaceuticals, llc
Dosage Form LOTION
Routes
TOPICAL
Active Ingredients

metronidazole 7.5 mg/mL

Manufacturer
Fougera Pharmaceuticals, LLC

Identifiers & Regulatory

Product NDC 0168-0383
Product ID 0168-0383_76e5eaff-57c7-4120-af16-c7e8cbac8688
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA077197
Listing Expiration 2027-12-31
Marketing Start 2006-05-24

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 01680383
Hyphenated Format 0168-0383

Supplemental Identifiers

RxCUI
242736
UPC
0301680383606
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 ANDA077197 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 7.5 mg/mL
source: ndc
Packaging
  • 59 mL in 1 BOTTLE, PLASTIC (0168-0383-60)
source: ndc

Packages (1)

0168-0383-60 59 mL in 1 BOTTLE, PLASTIC (0168-0383-60)

Ingredients (1)

metronidazole (7.5 mg/mL)

Linked Drug Pages (1)

Metronidazole ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "76e5eaff-57c7-4120-af16-c7e8cbac8688", "openfda": {"nui": ["N0000175435", "M0014907"], "upc": ["0301680383606"], "unii": ["140QMO216E"], "rxcui": ["242736"], "spl_set_id": ["5368755a-dd37-4e34-843f-ece6bac8ef6a"], "pharm_class_cs": ["Nitroimidazoles [CS]"], "pharm_class_epc": ["Nitroimidazole Antimicrobial [EPC]"], "manufacturer_name": ["Fougera Pharmaceuticals, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "59 mL in 1 BOTTLE, PLASTIC (0168-0383-60)", "package_ndc": "0168-0383-60", "marketing_start_date": "20060524"}], "brand_name": "Metronidazole", "product_id": "0168-0383_76e5eaff-57c7-4120-af16-c7e8cbac8688", "dosage_form": "LOTION", "pharm_class": ["Nitroimidazole Antimicrobial [EPC]", "Nitroimidazoles [CS]"], "product_ndc": "0168-0383", "generic_name": "Metronidazole", "labeler_name": "Fougera Pharmaceuticals, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Metronidazole", "active_ingredients": [{"name": "METRONIDAZOLE", "strength": "7.5 mg/mL"}], "application_number": "ANDA077197", "marketing_category": "ANDA", "marketing_start_date": "20060524", "listing_expiration_date": "20271231"}