Entacapone
- Product NDC
- 0904-6822
- 11-digit product format
- 009046822
- Labeler code
- 0904
- Product ID
- 0904-6822_3e89aac1-4b38-41fd-bbd7-af716570f424
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Entacapone
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Major Pharmaceuticals
- Application
- ANDA203437
- Marketing category
- ANDA
- Marketing start
- 2015-06-19
- 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 |
|---|
| 0904-6822-04 | Entacapone | 30 in 1 CARTON | TABLET, FILM COATED | 30 | | 6 |
| 0904-6822-04 | Entacapone | 1 in 1 BLISTER PACK | TABLET, FILM COATED | 1 | | 6 |
| 0904-6822-07 | Entacapone | 1 in 1 BLISTER PACK | TABLET, FILM COATED | 1 | | 6 |
| 0904-6822-07 | Entacapone | 30 in 1 CARTON | TABLET, FILM COATED | 30 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0904-6822 | ENTACAPONE TABLET, FILM COATED [MAJOR PHARMACEUTICALS] | 5 | Current NDC, Legacy NDC, 4 package rows | 20240503_863025af-2b71-477d-baa9-3ce7f435e385.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 |
|---|
| 0904-6822-04 | 00904682204 | 30 BLISTER PACK in 1 CARTON (0904-6822-04) > 1 TABLET, FILM COATED in 1 BLISTER PACK | 30 blister pack | 2015-06-19 | 0000-00-00 | No | No | Current |
| 0904-6822-07 | 00904682207 | 30 BLISTER PACK in 1 CARTON (0904-6822-07) / 1 TABLET, FILM COATED in 1 BLISTER PACK | 30 blister pack | 2024-05-02 | | No | No | Historical |