tinidazole

Generic: tinidazole

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

Drug Facts

Product Profile

Brand Name tinidazole
Generic Name tinidazole
Labeler chartwell rx, llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

tinidazole 250 mg/1

Manufacturer
Chartwell RX, LLC

Identifiers & Regulatory

Product NDC 62135-834
Product ID 62135-834_1d71c803-2d38-ccc8-e063-6294a90a7923
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA202044
Listing Expiration 2026-12-31
Marketing Start 2012-04-30

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 62135834
Hyphenated Format 62135-834

Supplemental Identifiers

RxCUI
199519 477234
UPC
0362135834203 0362135835200
UNII
033KF7V46H
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 tinidazole (source: ndc)
Generic Name tinidazole (source: ndc)
Application Number ANDA202044 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 250 mg/1
source: ndc
Packaging
  • 20 TABLET, FILM COATED in 1 BOTTLE (62135-834-20)
source: ndc

Packages (1)

62135-834-20 20 TABLET, FILM COATED in 1 BOTTLE (62135-834-20)

Ingredients (1)

tinidazole (250 mg/1)

Linked Drug Pages (1)

Tinidazole ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "1d71c803-2d38-ccc8-e063-6294a90a7923", "openfda": {"nui": ["N0000175435", "M0014907"], "upc": ["0362135834203", "0362135835200"], "unii": ["033KF7V46H"], "rxcui": ["199519", "477234"], "spl_set_id": ["b39bc167-f1c4-4169-8b46-e6c2eafe6bbf"], "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": "20 TABLET, FILM COATED in 1 BOTTLE (62135-834-20)", "package_ndc": "62135-834-20", "marketing_start_date": "20240705"}], "brand_name": "Tinidazole", "product_id": "62135-834_1d71c803-2d38-ccc8-e063-6294a90a7923", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Nitroimidazole Antimicrobial [EPC]", "Nitroimidazoles [CS]"], "product_ndc": "62135-834", "generic_name": "Tinidazole", "labeler_name": "Chartwell RX, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Tinidazole", "active_ingredients": [{"name": "TINIDAZOLE", "strength": "250 mg/1"}], "application_number": "ANDA202044", "marketing_category": "ANDA", "marketing_start_date": "20120430", "listing_expiration_date": "20261231"}