metronidazole

Generic: metronidazole

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

Drug Facts

Product Profile

Brand Name metronidazole
Generic Name metronidazole
Labeler chartwell rx, llc
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

metronidazole 375 mg/1

Manufacturer
Chartwell RX, LLC

Identifiers & Regulatory

Product NDC 62135-836
Product ID 62135-836_128cb585-c2bf-5e15-e063-6394a90a04aa
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA076522
Listing Expiration 2026-12-31
Marketing Start 2004-01-29

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 62135836
Hyphenated Format 62135-836

Supplemental Identifiers

RxCUI
199055
UPC
0362135836504
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 ANDA076522 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 375 mg/1
source: ndc
Packaging
  • 50 CAPSULE in 1 BOTTLE (62135-836-50)
source: ndc

Packages (1)

62135-836-50 50 CAPSULE in 1 BOTTLE (62135-836-50)

Ingredients (1)

metronidazole (375 mg/1)

Linked Drug Pages (1)

Metronidazole ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "128cb585-c2bf-5e15-e063-6394a90a04aa", "openfda": {"nui": ["N0000175435", "M0014907"], "upc": ["0362135836504"], "unii": ["140QMO216E"], "rxcui": ["199055"], "spl_set_id": ["f053ad94-d884-457c-9c35-4e0df1d26eea"], "pharm_class_cs": ["Nitroimidazoles [CS]"], "pharm_class_epc": ["Nitroimidazole Antimicrobial [EPC]"], "manufacturer_name": ["Chartwell RX, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "50 CAPSULE in 1 BOTTLE (62135-836-50)", "package_ndc": "62135-836-50", "marketing_start_date": "20240215"}], "brand_name": "Metronidazole", "product_id": "62135-836_128cb585-c2bf-5e15-e063-6394a90a04aa", "dosage_form": "CAPSULE", "pharm_class": ["Nitroimidazole Antimicrobial [EPC]", "Nitroimidazoles [CS]"], "product_ndc": "62135-836", "generic_name": "Metronidazole", "labeler_name": "Chartwell RX, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Metronidazole", "active_ingredients": [{"name": "METRONIDAZOLE", "strength": "375 mg/1"}], "application_number": "ANDA076522", "marketing_category": "ANDA", "marketing_start_date": "20040129", "listing_expiration_date": "20261231"}