Entacapone
- Product NDC
- 55648-781
- 11-digit product format
- 556480781
- Labeler code
- 55648
- Product ID
- 55648-781_db131736-7c7c-4f65-b2ee-b3d5f8e76ead
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Entacapone
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Wockhardt Limited
- Application
- NDA020796
- Marketing category
- NDA AUTHORIZED GENERIC
- Marketing start
- 2012-09-30
- Marketing end
- 0000-00-00
- Substance
- ENTACAPONE
- Active strength
- 200 mg/1
- Pharmacologic classes
- Catechol O-Methyltransferase Inhibitors [MoA],Catechol-O-Methyltransferase Inhibitor [EPC]
- NDC exclude flag
- E
- Listing certified through
- 2018-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 55648-781-02 | Entacapone | 1 in 1 CARTON | TABLET, FILM COATED | 1 | | 1 |
| 55648-781-02 | Entacapone | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | | 1 |
| 55648-781-03 | Entacapone | 500 in 1 BOTTLE | TABLET, FILM COATED | 500 | | 1 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| ENTACAPONE | ACTIVE INGREDIENT | 4975G9NM6T | ENTACAPONE TABLET, FILM COATED [WOCKHARDT LIMITED] | 1 | |
| ENTACAPONE | ACTIVE MOIETY | 4975G9NM6T | ENTACAPONE TABLET, FILM COATED [WOCKHARDT LIMITED] | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | ENTACAPONE TABLET, FILM COATED [WOCKHARDT LIMITED] | 1 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | ENTACAPONE TABLET, FILM COATED [WOCKHARDT LIMITED] | 1 | |
| FERRIC OXIDE RED | INACTIVE INGREDIENT | 1K09F3G675 | ENTACAPONE TABLET, FILM COATED [WOCKHARDT LIMITED] | 1 | |
| FERRIC OXIDE YELLOW | INACTIVE INGREDIENT | EX438O2MRT | ENTACAPONE TABLET, FILM COATED [WOCKHARDT LIMITED] | 1 | |
| GLYCERIN | INACTIVE INGREDIENT | PDC6A3C0OX | ENTACAPONE TABLET, FILM COATED [WOCKHARDT LIMITED] | 1 | |
| HYDROGENATED COTTONSEED OIL | INACTIVE INGREDIENT | Z82Y2C65EA | ENTACAPONE TABLET, FILM COATED [WOCKHARDT LIMITED] | 1 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | ENTACAPONE TABLET, FILM COATED [WOCKHARDT LIMITED] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | ENTACAPONE TABLET, FILM COATED [WOCKHARDT LIMITED] | 1 | |
| MANNITOL | INACTIVE INGREDIENT | 3OWL53L36A | ENTACAPONE TABLET, FILM COATED [WOCKHARDT LIMITED] | 1 | |
| POLYSORBATE 80 | INACTIVE INGREDIENT | 6OZP39ZG8H | ENTACAPONE TABLET, FILM COATED [WOCKHARDT LIMITED] | 1 | |
| SUCROSE | INACTIVE INGREDIENT | C151H8M554 | ENTACAPONE TABLET, FILM COATED [WOCKHARDT LIMITED] | 1 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | ENTACAPONE TABLET, FILM COATED [WOCKHARDT LIMITED] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 55648-781 | ENTACAPONE TABLET, FILM COATED [WOCKHARDT LIMITED] | 1 | Legacy NDC, 3 package rows | 20120930_5a68fa36-ed25-4309-8624-cd6a0001ec7f.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 55648-781-02 | 55648078102 | 1 in 1 CARTON | Historical |
| 55648-781-03 | 55648078103 | 500 in 1 BOTTLE | Historical |