tiopronin

Generic: tiopronin

Labeler: torrent pharmaceuticals limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name tiopronin
Generic Name tiopronin
Labeler torrent pharmaceuticals limited
Dosage Form TABLET, DELAYED RELEASE
Routes
ORAL
Active Ingredients

tiopronin 100 mg/1

Manufacturer
Torrent Pharmaceuticals Limited

Identifiers & Regulatory

Product NDC 13668-691
Product ID 13668-691_b56545da-a8ae-437a-9757-44862a6d95f0
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA216990
Listing Expiration 2026-12-31
Marketing Start 2024-01-30

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 13668691
Hyphenated Format 13668-691

Supplemental Identifiers

RxCUI
2178075 2178079
UPC
0313668692907 0313668691030
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 ANDA216990 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/1
source: ndc
Packaging
  • 300 TABLET, DELAYED RELEASE in 1 BOTTLE (13668-691-03)
source: ndc

Packages (1)

Ingredients (1)

tiopronin (100 mg/1)

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["ORAL"], "spl_id": "b56545da-a8ae-437a-9757-44862a6d95f0", "openfda": {"nui": ["N0000175549", "M0289359", "N0000175898"], "upc": ["0313668692907", "0313668691030"], "unii": ["C5W04GO61S"], "rxcui": ["2178075", "2178079"], "spl_set_id": ["ad750031-08ec-4d92-af2d-97a80c454e14"], "pharm_class_cs": ["N-substituted Glycines [CS]"], "pharm_class_epc": ["Reducing and Complexing Thiol [EPC]"], "pharm_class_moa": ["Cystine Disulfide Reduction [MoA]"], "manufacturer_name": ["Torrent Pharmaceuticals Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "300 TABLET, DELAYED RELEASE in 1 BOTTLE (13668-691-03)", "package_ndc": "13668-691-03", "marketing_start_date": "20240130"}], "brand_name": "TIOPRONIN", "product_id": "13668-691_b56545da-a8ae-437a-9757-44862a6d95f0", "dosage_form": "TABLET, DELAYED RELEASE", "pharm_class": ["Cystine Disulfide Reduction [MoA]", "N-substituted Glycines [CS]", "Reducing and Complexing Thiol [EPC]"], "product_ndc": "13668-691", "generic_name": "tiopronin", "labeler_name": "Torrent Pharmaceuticals Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "TIOPRONIN", "active_ingredients": [{"name": "TIOPRONIN", "strength": "100 mg/1"}], "application_number": "ANDA216990", "marketing_category": "ANDA", "marketing_start_date": "20240130", "listing_expiration_date": "20261231"}