thiola ec

Generic: tiopronin

Labeler: mission pharmacal company
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name thiola ec
Generic Name tiopronin
Labeler mission pharmacal company
Dosage Form TABLET, DELAYED RELEASE
Routes
ORAL
Active Ingredients

tiopronin 300 mg/1

Manufacturer
Mission Pharmacal Company

Identifiers & Regulatory

Product NDC 0178-0901
Product ID 0178-0901_4098f871-874f-92ec-e063-6394a90af53f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA211843
Listing Expiration 2026-12-31
Marketing Start 2019-06-28

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 01780901
Hyphenated Format 0178-0901

Supplemental Identifiers

RxCUI
2178075 2178077 2178079 2178081
UPC
0301780901908 0301780902011
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 thiola ec (source: ndc)
Generic Name tiopronin (source: ndc)
Application Number NDA211843 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 300 mg/1
source: ndc
Packaging
  • 90 TABLET, DELAYED RELEASE in 1 BOTTLE (0178-0901-90)
source: ndc

Packages (1)

0178-0901-90 90 TABLET, DELAYED RELEASE in 1 BOTTLE (0178-0901-90)

Ingredients (1)

tiopronin (300 mg/1)

Linked Drug Pages (1)

Thiola EC ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "4098f871-874f-92ec-e063-6394a90af53f", "openfda": {"nui": ["N0000175549", "M0289359", "N0000175898"], "upc": ["0301780901908", "0301780902011"], "unii": ["C5W04GO61S"], "rxcui": ["2178075", "2178077", "2178079", "2178081"], "spl_set_id": ["20298a52-a194-a161-8632-d84b6f26e23c"], "pharm_class_cs": ["N-substituted Glycines [CS]"], "pharm_class_epc": ["Reducing and Complexing Thiol [EPC]"], "pharm_class_moa": ["Cystine Disulfide Reduction [MoA]"], "manufacturer_name": ["Mission Pharmacal Company"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "90 TABLET, DELAYED RELEASE in 1 BOTTLE (0178-0901-90)", "package_ndc": "0178-0901-90", "marketing_start_date": "20190628"}], "brand_name": "Thiola EC", "product_id": "0178-0901_4098f871-874f-92ec-e063-6394a90af53f", "dosage_form": "TABLET, DELAYED RELEASE", "pharm_class": ["Cystine Disulfide Reduction [MoA]", "N-substituted Glycines [CS]", "Reducing and Complexing Thiol [EPC]"], "product_ndc": "0178-0901", "generic_name": "tiopronin", "labeler_name": "Mission Pharmacal Company", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Thiola EC", "active_ingredients": [{"name": "TIOPRONIN", "strength": "300 mg/1"}], "application_number": "NDA211843", "marketing_category": "NDA", "marketing_start_date": "20190628", "listing_expiration_date": "20261231"}