tinidazole

Generic: tinidazole

Labeler: edenbridge pharmaceuticals llc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name tinidazole
Generic Name tinidazole
Labeler edenbridge pharmaceuticals llc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

tinidazole 500 mg/1

Manufacturer
Edenbridge Pharmaceuticals LLC.

Identifiers & Regulatory

Product NDC 42799-208
Product ID 42799-208_462f7240-9709-4782-e063-6294a90a9e28
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA203808
Listing Expiration 2026-12-31
Marketing Start 2019-12-20

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 42799208
Hyphenated Format 42799-208

Supplemental Identifiers

RxCUI
199519 477234
UPC
0342799207018 0342799208015
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 ANDA203808 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
source: ndc
Packaging
  • 20 TABLET in 1 BOTTLE (42799-208-01)
  • 60 TABLET in 1 BOTTLE (42799-208-02)
source: ndc

Packages (2)

42799-208-01 20 TABLET in 1 BOTTLE (42799-208-01) 42799-208-02 60 TABLET in 1 BOTTLE (42799-208-02)

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": "462f7240-9709-4782-e063-6294a90a9e28", "openfda": {"nui": ["N0000175435", "M0014907"], "upc": ["0342799207018", "0342799208015"], "unii": ["033KF7V46H"], "rxcui": ["199519", "477234"], "spl_set_id": ["6f3ce597-64c1-4204-a67a-8b6f6e7e8bca"], "pharm_class_cs": ["Nitroimidazoles [CS]"], "pharm_class_epc": ["Nitroimidazole Antimicrobial [EPC]"], "manufacturer_name": ["Edenbridge Pharmaceuticals LLC."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "20 TABLET in 1 BOTTLE (42799-208-01)", "package_ndc": "42799-208-01", "marketing_start_date": "20191220"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE (42799-208-02)", "package_ndc": "42799-208-02", "marketing_start_date": "20191220"}], "brand_name": "Tinidazole", "product_id": "42799-208_462f7240-9709-4782-e063-6294a90a9e28", "dosage_form": "TABLET", "pharm_class": ["Nitroimidazole Antimicrobial [EPC]", "Nitroimidazoles [CS]"], "product_ndc": "42799-208", "generic_name": "Tinidazole", "labeler_name": "Edenbridge Pharmaceuticals LLC.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Tinidazole", "active_ingredients": [{"name": "TINIDAZOLE", "strength": "500 mg/1"}], "application_number": "ANDA203808", "marketing_category": "ANDA", "marketing_start_date": "20191220", "listing_expiration_date": "20261231"}