TOLCAPONE
- Product NDC
- 50742-193
- 11-digit product format
- 507420193
- Labeler code
- 50742
- Product ID
- 50742-193_b0eeccbf-775d-4ff7-805c-cc176f965198
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- tolcapone
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Ingenus Pharmaceuticals, LLC
- Application
- ANDA208937
- Marketing category
- ANDA
- Marketing start
- 2018-08-21
- 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 |
|---|
| 50742-193-90 | TOLCAPONE | 90 in 1 BOTTLE | TABLET | 90 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 50742-193 | TOLCAPONE TABLET [INGENUS PHARMACEUTICALS, LLC] | 5 | Current NDC, Legacy NDC, 1 package rows | 20190911_d94891be-2fef-4e39-8e35-ab7afe93e78e.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 50742-193-90 | 50742019390 | 90 TABLET in 1 BOTTLE (50742-193-90) | 90 tablet | 2018-08-21 | 0000-00-00 | No | No | Current |