Entacapone
- Product NDC
- 55648-711
- 11-digit product format
- 556480711
- Labeler code
- 55648
- Product ID
- 55648-711_419accad-98ef-4290-ba9c-be6a387a0202
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Entacapone
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Wockhardt Limited
- Application
- ANDA078941
- Marketing category
- ANDA
- Marketing start
- 2012-08-16
- 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 |
|---|
| 55648-711-01 | Entacapone | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 2 |
| 55648-711-02 | Entacapone | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | | 2 |
| 55648-711-03 | Entacapone | 500 in 1 BOTTLE | TABLET, FILM COATED | 500 | | 2 |
| 55648-711-04 | Entacapone | 10 in 1 BLISTER PACK | TABLET, FILM COATED | 10 | | 2 |
| 55648-711-04 | Entacapone | 10 in 1 CARTON | TABLET, FILM COATED | 10 | | 2 |
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] | 2 | |
| ENTACAPONE | ACTIVE MOIETY | 4975G9NM6T | ENTACAPONE TABLET, FILM COATED [WOCKHARDT LIMITED] | 2 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | ENTACAPONE TABLET, FILM COATED [WOCKHARDT LIMITED] | 2 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | ENTACAPONE TABLET, FILM COATED [WOCKHARDT LIMITED] | 2 | |
| D&C YELLOW NO. 10 | INACTIVE INGREDIENT | 35SW5USQ3G | ENTACAPONE TABLET, FILM COATED [WOCKHARDT LIMITED] | 2 | |
| FD&C YELLOW NO. 6 | INACTIVE INGREDIENT | H77VEI93A8 | ENTACAPONE TABLET, FILM COATED [WOCKHARDT LIMITED] | 2 | |
| HYDROGENATED COTTONSEED OIL | INACTIVE INGREDIENT | Z82Y2C65EA | ENTACAPONE TABLET, FILM COATED [WOCKHARDT LIMITED] | 2 | |
| HYPROMELLOSE 2910 (6 MPA.S) | INACTIVE INGREDIENT | 0WZ8WG20P6 | ENTACAPONE TABLET, FILM COATED [WOCKHARDT LIMITED] | 2 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | ENTACAPONE TABLET, FILM COATED [WOCKHARDT LIMITED] | 2 | |
| MANNITOL | INACTIVE INGREDIENT | 3OWL53L36A | ENTACAPONE TABLET, FILM COATED [WOCKHARDT LIMITED] | 2 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | ENTACAPONE TABLET, FILM COATED [WOCKHARDT LIMITED] | 2 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | ENTACAPONE TABLET, FILM COATED [WOCKHARDT LIMITED] | 2 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | ENTACAPONE TABLET, FILM COATED [WOCKHARDT LIMITED] | 2 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | ENTACAPONE TABLET, FILM COATED [WOCKHARDT LIMITED] | 2 | |
| TRIACETIN | INACTIVE INGREDIENT | XHX3C3X673 | ENTACAPONE TABLET, FILM COATED [WOCKHARDT LIMITED] | 2 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 55648-711 | ENTACAPONE TABLET, FILM COATED [WOCKHARDT LIMITED] | 2 | Legacy NDC, 5 package rows | 20121107_b9ac99ad-7e82-4064-8c66-214ac6d1776b.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 55648-711-01 | 55648071101 | 30 in 1 BOTTLE | Historical |
| 55648-711-02 | 55648071102 | 100 in 1 BOTTLE | Historical |
| 55648-711-03 | 55648071103 | 500 in 1 BOTTLE | Historical |
| 55648-711-04 | 55648071104 | 10 in 1 BLISTER PACK | Historical |