tiopronin

Generic: tiopronin

Labeler: endo usa, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name tiopronin
Generic Name tiopronin
Labeler endo usa, inc.
Dosage Form TABLET, DELAYED RELEASE
Routes
ORAL
Active Ingredients

tiopronin 300 mg/1

Manufacturer
Endo USA, Inc.

Identifiers & Regulatory

Product NDC 0254-3035
Product ID 0254-3035_44d74b79-7146-42ef-ace2-fa64cffeb041
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA217219
Listing Expiration 2026-12-31
Marketing Start 2024-06-26

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 02543035
Hyphenated Format 0254-3035

Supplemental Identifiers

RxCUI
2178075 2178079
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 ANDA217219 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 300 mg/1
source: ndc
Packaging
  • 90 TABLET, DELAYED RELEASE in 1 BOTTLE (0254-3035-09)
source: ndc

Packages (1)

0254-3035-09 90 TABLET, DELAYED RELEASE in 1 BOTTLE (0254-3035-09)

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": "44d74b79-7146-42ef-ace2-fa64cffeb041", "openfda": {"nui": ["N0000175549", "M0289359", "N0000175898"], "unii": ["C5W04GO61S"], "rxcui": ["2178075", "2178079"], "spl_set_id": ["5396b9fd-5385-44fd-a8ba-e56a46a33bc7"], "pharm_class_cs": ["N-substituted Glycines [CS]"], "pharm_class_epc": ["Reducing and Complexing Thiol [EPC]"], "pharm_class_moa": ["Cystine Disulfide Reduction [MoA]"], "manufacturer_name": ["Endo USA, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "90 TABLET, DELAYED RELEASE in 1 BOTTLE (0254-3035-09)", "package_ndc": "0254-3035-09", "marketing_start_date": "20240626"}], "brand_name": "TIOPRONIN", "product_id": "0254-3035_44d74b79-7146-42ef-ace2-fa64cffeb041", "dosage_form": "TABLET, DELAYED RELEASE", "pharm_class": ["Cystine Disulfide Reduction [MoA]", "N-substituted Glycines [CS]", "Reducing and Complexing Thiol [EPC]"], "product_ndc": "0254-3035", "generic_name": "TIOPRONIN", "labeler_name": "Endo USA, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "TIOPRONIN", "active_ingredients": [{"name": "TIOPRONIN", "strength": "300 mg/1"}], "application_number": "ANDA217219", "marketing_category": "ANDA", "marketing_start_date": "20240626", "listing_expiration_date": "20261231"}