tindazole

Generic: tinidazole

Labeler: rising pharma holdings, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

tinidazole 250 mg/1

Manufacturer
Rising Pharma Holdings, Inc.

Identifiers & Regulatory

Product NDC 64980-426
Product ID 64980-426_8dbd79dd-9243-4413-aa01-ba1301573a48
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA202489
Listing Expiration 2026-12-31
Marketing Start 2013-10-09

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 64980426
Hyphenated Format 64980-426

Supplemental Identifiers

RxCUI
199519 477234
UPC
0364980426022
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 tindazole (source: ndc)
Generic Name tinidazole (source: ndc)
Application Number ANDA202489 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 250 mg/1
source: ndc
Packaging
  • 20 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (64980-426-02)
source: ndc

Packages (1)

64980-426-02 20 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (64980-426-02)

Ingredients (1)

tinidazole (250 mg/1)

Linked Drug Pages (1)

Tindazole ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "8dbd79dd-9243-4413-aa01-ba1301573a48", "openfda": {"nui": ["N0000175435", "M0014907"], "upc": ["0364980426022"], "unii": ["033KF7V46H"], "rxcui": ["199519", "477234"], "spl_set_id": ["32167dd7-5d37-457b-9b00-cd735de6b060"], "pharm_class_cs": ["Nitroimidazoles [CS]"], "pharm_class_epc": ["Nitroimidazole Antimicrobial [EPC]"], "manufacturer_name": ["Rising Pharma Holdings, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "20 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (64980-426-02)", "package_ndc": "64980-426-02", "marketing_start_date": "20131009"}], "brand_name": "Tindazole", "product_id": "64980-426_8dbd79dd-9243-4413-aa01-ba1301573a48", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Nitroimidazole Antimicrobial [EPC]", "Nitroimidazoles [CS]"], "product_ndc": "64980-426", "generic_name": "Tinidazole", "labeler_name": "Rising Pharma Holdings, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Tindazole", "active_ingredients": [{"name": "TINIDAZOLE", "strength": "250 mg/1"}], "application_number": "ANDA202489", "marketing_category": "ANDA", "marketing_start_date": "20131009", "listing_expiration_date": "20261231"}