Entacapone
- Product NDC
- 64679-711
- 11-digit product format
- 646790711
- Labeler code
- 64679
- Product ID
- 64679-711_d44bf70c-0a64-0c03-e053-2a95a90a6b53
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Entacapone
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Wockhardt USA LLC.
- 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
- No
- Listing certified through
- 2022-12-31
- Current FDA listing
- Historical FDA.report record
FDA-Initiated Inactive NDC Indexing#
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| ENTACAPONE | ACTIVE INGREDIENT | 4975G9NM6T | ENTACAPONE TABLET, FILM COATED [WOCKHARDT USA LLC.] | 2 | |
| ENTACAPONE | ACTIVE MOIETY | 4975G9NM6T | ENTACAPONE TABLET, FILM COATED [WOCKHARDT USA LLC.] | 2 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | ENTACAPONE TABLET, FILM COATED [WOCKHARDT USA LLC.] | 2 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | ENTACAPONE TABLET, FILM COATED [WOCKHARDT USA LLC.] | 2 | |
| D&C YELLOW NO. 10 | INACTIVE INGREDIENT | 35SW5USQ3G | ENTACAPONE TABLET, FILM COATED [WOCKHARDT USA LLC.] | 2 | |
| FD&C YELLOW NO. 6 | INACTIVE INGREDIENT | H77VEI93A8 | ENTACAPONE TABLET, FILM COATED [WOCKHARDT USA LLC.] | 2 | |
| HYDROGENATED COTTONSEED OIL | INACTIVE INGREDIENT | Z82Y2C65EA | ENTACAPONE TABLET, FILM COATED [WOCKHARDT USA LLC.] | 2 | |
| HYPROMELLOSE 2910 (6 MPA.S) | INACTIVE INGREDIENT | 0WZ8WG20P6 | ENTACAPONE TABLET, FILM COATED [WOCKHARDT USA LLC.] | 2 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | ENTACAPONE TABLET, FILM COATED [WOCKHARDT USA LLC.] | 2 | |
| MANNITOL | INACTIVE INGREDIENT | 3OWL53L36A | ENTACAPONE TABLET, FILM COATED [WOCKHARDT USA LLC.] | 2 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | ENTACAPONE TABLET, FILM COATED [WOCKHARDT USA LLC.] | 2 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | ENTACAPONE TABLET, FILM COATED [WOCKHARDT USA LLC.] | 2 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | ENTACAPONE TABLET, FILM COATED [WOCKHARDT USA LLC.] | 2 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | ENTACAPONE TABLET, FILM COATED [WOCKHARDT USA LLC.] | 2 | |
| TRIACETIN | INACTIVE INGREDIENT | XHX3C3X673 | ENTACAPONE TABLET, FILM COATED [WOCKHARDT USA LLC.] | 2 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 64679-711 | ENTACAPONE TABLET, FILM COATED [WOCKHARDT USA LLC.] | 6 | Legacy NDC | 20211230_01ea62f4-bfac-485a-bb4b-a9abb345749f.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 64679-711-01 | 64679071101 | 30 TABLET, FILM COATED in 1 BOTTLE (64679-711-01) | | 2012-08-16 | 0000-00-00 | No | No | Current |
| 64679-711-02 | 64679071102 | 100 TABLET, FILM COATED in 1 BOTTLE (64679-711-02) | | 2012-08-16 | 0000-00-00 | No | No | Current |
| 64679-711-03 | 64679071103 | 500 TABLET, FILM COATED in 1 BOTTLE (64679-711-03) | | 2012-08-16 | 0000-00-00 | No | No | Current |
| 64679-711-04 | 64679071104 | 10 BLISTER PACK in 1 CARTON (64679-711-04) > 10 TABLET, FILM COATED in 1 BLISTER PACK | 10 blister pack | 2012-08-16 | 0000-00-00 | No | No | Current |