tiopronin

Generic: tiopronin

Labeler: biocomp pharma, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA AUTHORIZED GENERIC Inactive Finished

Drug Facts

Product Profile

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

tiopronin 100 mg/1

Manufacturer
BioComp Pharma, Inc.

Identifiers & Regulatory

Product NDC 44523-054
Product ID 44523-054_36d7fad3-57c6-67e7-e063-6294a90ad7b5
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA AUTHORIZED GENERIC
Application Number NDA211843
Listing Expiration 2026-12-31
Marketing Start 2024-12-05

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 44523054
Hyphenated Format 44523-054

Supplemental Identifiers

RxCUI
2178075 2178079
UPC
0344523055018 0344523054011
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 NDA211843 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/1
source: ndc
Packaging
  • 300 TABLET, DELAYED RELEASE in 1 BOTTLE (44523-054-01)
source: ndc

Packages (1)

44523-054-01 300 TABLET, DELAYED RELEASE in 1 BOTTLE (44523-054-01)

Ingredients (1)

tiopronin (100 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": "36d7fad3-57c6-67e7-e063-6294a90ad7b5", "openfda": {"nui": ["N0000175549", "M0289359", "N0000175898"], "upc": ["0344523055018", "0344523054011"], "unii": ["C5W04GO61S"], "rxcui": ["2178075", "2178079"], "spl_set_id": ["1f2eb1d6-faa6-e352-e063-6294a90a7fb5"], "pharm_class_cs": ["N-substituted Glycines [CS]"], "pharm_class_epc": ["Reducing and Complexing Thiol [EPC]"], "pharm_class_moa": ["Cystine Disulfide Reduction [MoA]"], "manufacturer_name": ["BioComp Pharma, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "300 TABLET, DELAYED RELEASE in 1 BOTTLE (44523-054-01)", "package_ndc": "44523-054-01", "marketing_start_date": "20241205"}], "brand_name": "Tiopronin", "product_id": "44523-054_36d7fad3-57c6-67e7-e063-6294a90ad7b5", "dosage_form": "TABLET, DELAYED RELEASE", "pharm_class": ["Cystine Disulfide Reduction [MoA]", "N-substituted Glycines [CS]", "Reducing and Complexing Thiol [EPC]"], "product_ndc": "44523-054", "generic_name": "Tiopronin", "labeler_name": "BioComp Pharma, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Tiopronin", "active_ingredients": [{"name": "TIOPRONIN", "strength": "100 mg/1"}], "application_number": "NDA211843", "marketing_category": "NDA AUTHORIZED GENERIC", "marketing_start_date": "20241205", "listing_expiration_date": "20261231"}