NDC 50742-193

TOLCAPONE

Tolcapone

TOLCAPONE is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Ingenus Pharmaceuticals, Llc. The primary component is Tolcapone.

• Product ID: 50742-193_658c55ce-6b19-4c53-8563-d03ea83f7ccd
• NDC: 50742-193
• Product Type: Human Prescription Drug
• Proprietary Name: TOLCAPONE
• Generic Name: Tolcapone
• Dosage Form: Tablet
• Route of Administration: ORAL
• Marketing Start Date: 2018-08-21
• Marketing Category: ANDA / ANDA
• Application Number: ANDA208937
• Labeler Name: Ingenus Pharmaceuticals, LLC
• Substance Name: TOLCAPONE
• Active Ingredient Strength: 100 mg/1
• Pharm Classes: Catechol O-Methyltransferase Inhibitors [MoA],Catechol-O-Methyltransferase Inhibitor [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 50742-193-90

90 TABLET in 1 BOTTLE (50742-193-90)

• Marketing Start Date: 2018-08-21
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 50742-193-90 [50742019390]

TOLCAPONE TABLET

• Marketing Category: ANDA
• Application Number: ANDA208937
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2018-08-21

Drug Details

Active Ingredients

Ingredient	Strength
TOLCAPONE	100 mg/1

OpenFDA Data

• SPL SET ID: d94891be-2fef-4e39-8e35-ab7afe93e78e
• Manufacturer:
  • Ingenus Pharmaceuticals, LLC
• UNII:
  • CIF6334OLY
• RxNorm Concept Unique ID - RxCUI:
  • 200220

Pharmacological Class

• Catechol O-Methyltransferase Inhibitors [MoA]
• Catechol-O-Methyltransferase Inhibitor [EPC]

NDC Crossover Matching brand name "TOLCAPONE" or generic name "Tolcapone"

NDC	Brand Name	Generic Name
49884-254	Tolcapone	Tolcapone
50742-193	TOLCAPONE	tolcapone
68682-938	Tolcapone	Tolcapone
0187-0938	Tasmar	Tolcapone