tinidazole

Generic: tinidazole

Labeler: biocomp pharma, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA AUTHORIZED GENERIC Inactive Finished

Drug Facts

Product Profile

Brand Name tinidazole
Generic Name tinidazole
Labeler biocomp pharma, inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

tinidazole 500 mg/1

Manufacturer
BioComp Pharma, Inc.

Identifiers & Regulatory

Product NDC 44523-450
Product ID 44523-450_44ecbffa-e4aa-9dd3-e063-6394a90a4d48
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA AUTHORIZED GENERIC
Application Number NDA021618
Listing Expiration 2026-12-31
Marketing Start 2025-03-20

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 44523450
Hyphenated Format 44523-450

Supplemental Identifiers

RxCUI
199519
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 NDA021618 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
source: ndc
Packaging
  • 12 TABLET, FILM COATED in 1 BOTTLE (44523-450-12)
  • 20 TABLET, FILM COATED in 1 BOTTLE (44523-450-20)
source: ndc

Packages (2)

44523-450-12 12 TABLET, FILM COATED in 1 BOTTLE (44523-450-12) 44523-450-20 20 TABLET, FILM COATED in 1 BOTTLE (44523-450-20)

Ingredients (1)

tinidazole (500 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": "44ecbffa-e4aa-9dd3-e063-6394a90a4d48", "openfda": {"nui": ["N0000175435", "M0014907"], "unii": ["033KF7V46H"], "rxcui": ["199519"], "spl_set_id": ["f55bcc41-2e8d-4ee5-9993-05c7d86f2d2c"], "pharm_class_cs": ["Nitroimidazoles [CS]"], "pharm_class_epc": ["Nitroimidazole Antimicrobial [EPC]"], "manufacturer_name": ["BioComp Pharma, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "12 TABLET, FILM COATED in 1 BOTTLE (44523-450-12)", "package_ndc": "44523-450-12", "marketing_start_date": "20250320"}, {"sample": false, "description": "20 TABLET, FILM COATED in 1 BOTTLE (44523-450-20)", "package_ndc": "44523-450-20", "marketing_start_date": "20250320"}], "brand_name": "Tinidazole", "product_id": "44523-450_44ecbffa-e4aa-9dd3-e063-6394a90a4d48", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Nitroimidazole Antimicrobial [EPC]", "Nitroimidazoles [CS]"], "product_ndc": "44523-450", "generic_name": "tinidazole", "labeler_name": "BioComp Pharma, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Tinidazole", "active_ingredients": [{"name": "TINIDAZOLE", "strength": "500 mg/1"}], "application_number": "NDA021618", "marketing_category": "NDA AUTHORIZED GENERIC", "marketing_start_date": "20250320", "listing_expiration_date": "20261231"}