MedPath

Tolcapone

Tolcapone Tablets 100 mg

Approved
Approval ID

dd367eec-359a-4065-b5c3-7c0107c823fe

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Oct 1, 2020

Manufacturers
FDA

Oceanside Pharmaceuticals

DUNS: 832011691

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Tolcapone

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code68682-938
Application NumberNDA020697
Product Classification
M
Marketing Category
C73605
G
Generic Name
Tolcapone
Product Specifications
Route of AdministrationORAL
Effective DateOctober 1, 2020
FDA Product Classification

INGREDIENTS (16)

TolcaponeActive
Quantity: 100 mg in 1 1
Code: CIF6334OLY
Classification: ACTIB
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
ANHYDROUS DIBASIC CALCIUM PHOSPHATEInactive
Code: L11K75P92J
Classification: IACT
Lactose MonohydrateInactive
Code: EWQ57Q8I5X
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
talcInactive
Code: 7SEV7J4R1U
Classification: IACT
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
ferric oxide yellowInactive
Code: EX438O2MRT
Classification: IACT
titanium dioxideInactive
Code: 15FIX9V2JP
Classification: IACT
triacetinInactive
Code: XHX3C3X673
Classification: IACT
sodium lauryl sulfateInactive
Code: 368GB5141J
Classification: IACT
ferric oxide redInactive
Code: 1K09F3G675
Classification: IACT
ETHYLCELLULOSE, UNSPECIFIEDInactive
Code: 7Z8S9VYZ4B
Classification: IACT

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Tolcapone - FDA Drug Approval Details