tinidazole

Generic: tinidazole

Labeler: lupin pharmaceuticals,inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name tinidazole
Generic Name tinidazole
Labeler lupin pharmaceuticals,inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

tinidazole 500 mg/1

Manufacturer
Lupin Pharmaceuticals,Inc.

Identifiers & Regulatory

Product NDC 43386-551
Product ID 43386-551_98a66e10-fb32-46ce-a68b-c21d615f6621
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 43386551
Hyphenated Format 43386-551

Supplemental Identifiers

RxCUI
199519 477234
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
  • 500 mg/1
source: ndc
Packaging
  • 20 TABLET in 1 BOTTLE (43386-551-02)
  • 60 TABLET in 1 BOTTLE (43386-551-06)
source: ndc

Packages (2)

43386-551-02 20 TABLET in 1 BOTTLE (43386-551-02) 43386-551-06 60 TABLET in 1 BOTTLE (43386-551-06)

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": "98a66e10-fb32-46ce-a68b-c21d615f6621", "openfda": {"nui": ["N0000175435", "M0014907"], "unii": ["033KF7V46H"], "rxcui": ["199519", "477234"], "spl_set_id": ["95ab57b2-5d7e-4986-abcd-65edf1728383"], "pharm_class_cs": ["Nitroimidazoles [CS]"], "pharm_class_epc": ["Nitroimidazole Antimicrobial [EPC]"], "manufacturer_name": ["Lupin Pharmaceuticals,Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "20 TABLET in 1 BOTTLE (43386-551-02)", "package_ndc": "43386-551-02", "marketing_start_date": "20120430"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE (43386-551-06)", "package_ndc": "43386-551-06", "marketing_start_date": "20120430"}], "brand_name": "Tinidazole", "product_id": "43386-551_98a66e10-fb32-46ce-a68b-c21d615f6621", "dosage_form": "TABLET", "pharm_class": ["Nitroimidazole Antimicrobial [EPC]", "Nitroimidazoles [CS]"], "product_ndc": "43386-551", "generic_name": "Tinidazole", "labeler_name": "Lupin Pharmaceuticals,Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Tinidazole", "active_ingredients": [{"name": "TINIDAZOLE", "strength": "500 mg/1"}], "application_number": "ANDA202044", "marketing_category": "ANDA", "marketing_start_date": "20120430", "listing_expiration_date": "20261231"}