NDC 0178-0900

Thiola

Tiopronin

Thiola is a Oral Tablet, Sugar Coated in the Human Prescription Drug category. It is labeled and distributed by Mission Pharmacal Company. The primary component is Tiopronin.

• Product ID: 0178-0900_78d3585e-44cb-748a-e053-2991aa0a5e2c
• NDC: 0178-0900
• Product Type: Human Prescription Drug
• Proprietary Name: Thiola
• Generic Name: Tiopronin
• Dosage Form: Tablet, Sugar Coated
• Route of Administration: ORAL
• Marketing Start Date: 1988-08-11
• Marketing Category: NDA / NDA
• Application Number: NDA019569
• Labeler Name: Mission Pharmacal Company
• Substance Name: TIOPRONIN
• Active Ingredient Strength: 100 mg/1
• Pharm Classes: Cystine Disulfide Reduction [MoA],N-substituted Glycines [CS],Reducing and Complexing Thiol [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 0178-0900-01

100 TABLET, SUGAR COATED in 1 BOTTLE (0178-0900-01)

• Marketing Start Date: 1988-08-11
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0178-0900-01 [00178090001]

Thiola TABLET, SUGAR COATED

• Marketing Category: NDA
• Application Number: NDA019569
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 1988-08-11

Drug Details

Active Ingredients

Ingredient	Strength
TIOPRONIN	100 mg/1

OpenFDA Data

• SPL SET ID: 494a714e-923c-cd57-df6c-12886afb265a
• Manufacturer:
  • Mission Pharmacal Company
• UNII:
  • C5W04GO61S
• RxNorm Concept Unique ID - RxCUI:
  • 198287
  • 207840
• UPC Code:
  • 0301780900017

Pharmacological Class

• Cystine Disulfide Reduction [MoA]
• N-substituted Glycines [CS]
• Reducing and Complexing Thiol [EPC]

NDC Crossover Matching brand name "Thiola" or generic name "Tiopronin"

NDC	Brand Name	Generic Name
0178-0900	Thiola	tiopronin
0178-0901	Thiola EC	tiopronin
0178-0902	Thiola EC	tiopronin
0093-7909	Tiopronin	Tiopronin