Entacapone
- Product NDC
- 27241-049
- 11-digit product format
- 272410049
- Labeler code
- 27241
- Product ID
- 27241-049_bde2e229-3bc5-4d26-9bd8-0f679955ff33
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Entacapone
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Ajanta Pharma USA Inc.
- Application
- ANDA205792
- Marketing category
- ANDA
- Marketing start
- 2017-08-31
- 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 |
|---|
| 27241-049-10 | Entacapone | 100 in 1 BOTTLE | TABLET | 100 | | 55 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 27241-049 | ENTACAPONE TABLET [AJANTA PHARMA USA INC.] | 54 | Current NDC, Legacy NDC, 1 package rows | 20221129_e9e94e9f-cd7a-45f5-9aeb-9c28ed804d8c.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 |
|---|
| 27241-049-10 | 27241004910 | 100 TABLET in 1 BOTTLE (27241-049-10) | 100 tablet | 2017-08-31 | 0000-00-00 | No | No | Current |