Tolcapone
- Product NDC
- 68682-938
- 11-digit product format
- 686820938
- Labeler code
- 68682
- Product ID
- 68682-938_9ec63a14-0b6a-47eb-9258-19b6e3cb5b25
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Tolcapone
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Oceanside Pharmaceuticals
- Application
- NDA020697
- Marketing category
- NDA AUTHORIZED GENERIC
- Marketing start
- 2004-07-27
- Substance
- TOLCAPONE
- Active strength
- 100 mg/1
- Pharmacologic classes
- Catechol O-Methyltransferase Inhibitors [MoA], Catechol-O-Methyltransferase Inhibitor [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Tolcapone
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| TOLCAPONE | 100 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | CIF6334OLY |
| Rxcui | 200220 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68682-938-90 | Tolcapone | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 7 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| Tolcapone | ACTIVE INGREDIENT | CIF6334OLY | TOLCAPONE TABLET, FILM COATED [OCEANSIDE PHARMACEUTICALS] | 3 | |
| Tolcapone | ACTIVE MOIETY | CIF6334OLY | TOLCAPONE TABLET, FILM COATED [OCEANSIDE PHARMACEUTICALS] | 3 | |
| CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS | INACTIVE INGREDIENT | L11K75P92J | TOLCAPONE TABLET, FILM COATED [OCEANSIDE PHARMACEUTICALS] | 3 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | TOLCAPONE TABLET, FILM COATED [OCEANSIDE PHARMACEUTICALS] | 3 | |
| ethylcelluloses | INACTIVE INGREDIENT | 7Z8S9VYZ4B | TOLCAPONE TABLET, FILM COATED [OCEANSIDE PHARMACEUTICALS] | 3 | |
| ferric oxide red | INACTIVE INGREDIENT | 1K09F3G675 | TOLCAPONE TABLET, FILM COATED [OCEANSIDE PHARMACEUTICALS] | 3 | |
| ferric oxide yellow | INACTIVE INGREDIENT | EX438O2MRT | TOLCAPONE TABLET, FILM COATED [OCEANSIDE PHARMACEUTICALS] | 3 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | TOLCAPONE TABLET, FILM COATED [OCEANSIDE PHARMACEUTICALS] | 3 | |
| Lactose Monohydrate | INACTIVE INGREDIENT | EWQ57Q8I5X | TOLCAPONE TABLET, FILM COATED [OCEANSIDE PHARMACEUTICALS] | 3 | |
| magnesium stearate | INACTIVE INGREDIENT | 70097M6I30 | TOLCAPONE TABLET, FILM COATED [OCEANSIDE PHARMACEUTICALS] | 3 | |
| POVIDONES | INACTIVE INGREDIENT | FZ989GH94E | TOLCAPONE TABLET, FILM COATED [OCEANSIDE PHARMACEUTICALS] | 3 | |
| sodium lauryl sulfate | INACTIVE INGREDIENT | 368GB5141J | TOLCAPONE TABLET, FILM COATED [OCEANSIDE PHARMACEUTICALS] | 3 | |
| sodium starch glycolate type a potato | INACTIVE INGREDIENT | 5856J3G2A2 | TOLCAPONE TABLET, FILM COATED [OCEANSIDE PHARMACEUTICALS] | 3 | |
| talc | INACTIVE INGREDIENT | 7SEV7J4R1U | TOLCAPONE TABLET, FILM COATED [OCEANSIDE PHARMACEUTICALS] | 3 | |
| titanium dioxide | INACTIVE INGREDIENT | 15FIX9V2JP | TOLCAPONE TABLET, FILM COATED [OCEANSIDE PHARMACEUTICALS] | 3 | |
| triacetin | INACTIVE INGREDIENT | XHX3C3X673 | TOLCAPONE TABLET, FILM COATED [OCEANSIDE PHARMACEUTICALS] | 3 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68682-938 | TOLCAPONE TABLET, FILM COATED [OCEANSIDE PHARMACEUTICALS] | 7 | Current NDC, Legacy NDC, 1 package rows | 20210106_dd367eec-359a-4065-b5c3-7c0107c823fe.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 68682-938-90 | 68682093890 | 90 TABLET, FILM COATED in 1 BOTTLE (68682-938-90) | 2004-07-27 | 0000-00-00 | No | No | Current |