NDC 0178-0901

Thiola EC

Tiopronin

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

• Product ID: 0178-0901_0f5c7e8c-aea7-410d-b45c-9646d29e1d78
• NDC: 0178-0901
• Product Type: Human Prescription Drug
• Proprietary Name: Thiola EC
• Generic Name: Tiopronin
• Dosage Form: Tablet, Delayed Release
• Route of Administration: ORAL
• Marketing Start Date: 2019-06-28
• Marketing Category: NDA / NDA
• Application Number: NDA211843
• Labeler Name: Mission Pharmacal Company
• Substance Name: TIOPRONIN
• Active Ingredient Strength: 300 mg/1
• Pharm Classes: Cystine Disulfide Reduction [MoA],N-substituted Glycines [CS],Reducing and Complexing Thiol [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2022-12-31

Packaging

NDC 0178-0901-90

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

• Marketing Start Date: 2019-06-28
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0178-0901-90 [00178090190]

Thiola EC TABLET, DELAYED RELEASE

• Marketing Category: NDA
• Application Number: NDA211843
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2019-06-28

Drug Details

Active Ingredients

Ingredient	Strength
TIOPRONIN	300 mg/1

OpenFDA Data

• SPL SET ID: 20298a52-a194-a161-8632-d84b6f26e23c
• Manufacturer:
  • Mission Pharmacal Company
• UNII:
  • C5W04GO61S
• UPC Code:
  • 0301780901908
  • 0301780902011

Pharmacological Class

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

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

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