Entacapone
- Product NDC
- 0781-5578
- 11-digit product format
- 007815578
- Labeler code
- 0781
- Product ID
- 0781-5578_a5584d62-a95a-4a17-8c37-0f0bc72b9bb5
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Entacapone
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Sandoz Inc
- Application
- NDA020796
- Marketing category
- NDA AUTHORIZED GENERIC
- Marketing start
- 2014-06-04
- Substance
- ENTACAPONE
- Active strength
- 200 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
- Entacapone
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ENTACAPONE | 200 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 4975G9NM6T |
| Rxcui | 317094 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0781-5578-01 | Entacapone | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | | 14 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| ENTACAPONE | ACTIVE INGREDIENT | 4975G9NM6T | ENTACAPONE TABLET, FILM COATED [SANDOZ INC] | 10 | |
| ENTACAPONE | ACTIVE MOIETY | 4975G9NM6T | ENTACAPONE TABLET, FILM COATED [SANDOZ INC] | 10 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | ENTACAPONE TABLET, FILM COATED [SANDOZ INC] | 10 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | ENTACAPONE TABLET, FILM COATED [SANDOZ INC] | 10 | |
| FERRIC OXIDE RED | INACTIVE INGREDIENT | 1K09F3G675 | ENTACAPONE TABLET, FILM COATED [SANDOZ INC] | 10 | |
| FERRIC OXIDE YELLOW | INACTIVE INGREDIENT | EX438O2MRT | ENTACAPONE TABLET, FILM COATED [SANDOZ INC] | 10 | |
| GLYCERIN | INACTIVE INGREDIENT | PDC6A3C0OX | ENTACAPONE TABLET, FILM COATED [SANDOZ INC] | 10 | |
| HYDROGENATED COTTONSEED OIL | INACTIVE INGREDIENT | Z82Y2C65EA | ENTACAPONE TABLET, FILM COATED [SANDOZ INC] | 10 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | ENTACAPONE TABLET, FILM COATED [SANDOZ INC] | 10 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | ENTACAPONE TABLET, FILM COATED [SANDOZ INC] | 10 | |
| MANNITOL | INACTIVE INGREDIENT | 3OWL53L36A | ENTACAPONE TABLET, FILM COATED [SANDOZ INC] | 10 | |
| POLYSORBATE 80 | INACTIVE INGREDIENT | 6OZP39ZG8H | ENTACAPONE TABLET, FILM COATED [SANDOZ INC] | 10 | |
| SUCROSE | INACTIVE INGREDIENT | C151H8M554 | ENTACAPONE TABLET, FILM COATED [SANDOZ INC] | 10 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | ENTACAPONE TABLET, FILM COATED [SANDOZ INC] | 10 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0781-5578 | ENTACAPONE TABLET, FILM COATED [SANDOZ INC] | 14 | Current NDC, Legacy NDC, 1 package rows | 20241020_ad4b6d79-efd3-4c43-b4dc-5afdacf939a4.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 |
|---|
| 0781-5578-01 | 00781557801 | 100 TABLET, FILM COATED in 1 BOTTLE (0781-5578-01) | 2014-06-04 | 0000-00-00 | No | No | Current |