tiopronin

Generic: tiopronin

Labeler: amneal pharmaceuticals ny llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name tiopronin
Generic Name tiopronin
Labeler amneal pharmaceuticals ny llc
Dosage Form TABLET, DELAYED RELEASE
Routes
ORAL
Active Ingredients

tiopronin 300 mg/1

Manufacturer
Amneal Pharmaceuticals NY LLC

Identifiers & Regulatory

Product NDC 60219-2009
Product ID 60219-2009_98b9196d-4cc8-4ffe-8a45-8bced8f4284f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA216278
Listing Expiration 2026-12-31
Marketing Start 2025-01-02

Pharmacologic Class

Established (EPC)
reducing and complexing thiol [epc]
Mechanism of Action
cystine disulfide reduction [moa]
Chemical Structure
n-substituted glycines [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 602192009
Hyphenated Format 60219-2009

Supplemental Identifiers

RxCUI
2178079
UPC
0360219200999
UNII
C5W04GO61S
NUI
N0000175549 M0289359 N0000175898

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 tiopronin (source: ndc)
Generic Name tiopronin (source: ndc)
Application Number ANDA216278 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 300 mg/1
source: ndc
Packaging
  • 90 TABLET, DELAYED RELEASE in 1 BOTTLE (60219-2009-9)
source: ndc

Packages (1)

60219-2009-9 90 TABLET, DELAYED RELEASE in 1 BOTTLE (60219-2009-9)

Ingredients (1)

tiopronin (300 mg/1)

Linked Drug Pages (1)

tiopronin ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "98b9196d-4cc8-4ffe-8a45-8bced8f4284f", "openfda": {"nui": ["N0000175549", "M0289359", "N0000175898"], "upc": ["0360219200999"], "unii": ["C5W04GO61S"], "rxcui": ["2178079"], "spl_set_id": ["ce5b1f97-5b3c-40b6-b1c4-1d36025be1b8"], "pharm_class_cs": ["N-substituted Glycines [CS]"], "pharm_class_epc": ["Reducing and Complexing Thiol [EPC]"], "pharm_class_moa": ["Cystine Disulfide Reduction [MoA]"], "manufacturer_name": ["Amneal Pharmaceuticals NY LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "90 TABLET, DELAYED RELEASE in 1 BOTTLE (60219-2009-9)", "package_ndc": "60219-2009-9", "marketing_start_date": "20250102"}], "brand_name": "tiopronin", "product_id": "60219-2009_98b9196d-4cc8-4ffe-8a45-8bced8f4284f", "dosage_form": "TABLET, DELAYED RELEASE", "pharm_class": ["Cystine Disulfide Reduction [MoA]", "N-substituted Glycines [CS]", "Reducing and Complexing Thiol [EPC]"], "product_ndc": "60219-2009", "generic_name": "tiopronin", "labeler_name": "Amneal Pharmaceuticals NY LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "tiopronin", "active_ingredients": [{"name": "TIOPRONIN", "strength": "300 mg/1"}], "application_number": "ANDA216278", "marketing_category": "ANDA", "marketing_start_date": "20250102", "listing_expiration_date": "20261231"}