ENTACAPONE
- Product NDC
- 46708-478
- 11-digit product format
- 467080478
- Labeler code
- 46708
- Product ID
- 46708-478_49e45c73-b4c8-4f0e-8ad7-5a025ca5d5c8
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- ENTACAPONE
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Alembic Pharmaceuticals Limited
- Application
- ANDA212601
- Marketing category
- ANDA
- Marketing start
- 2022-01-06
- 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 |
|---|
| 46708-478-31 | ENTACAPONE | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | | 2 |
| 46708-478-91 | ENTACAPONE | 1000 in 1 BOTTLE | TABLET, FILM COATED | 1000 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 46708-478 | ENTACAPONE TABLET, FILM COATED [ALEMBIC PHARMACEUTICALS LIMITED] | 2 | Current NDC, Legacy NDC, 2 package rows | 20240110_d21ce241-b05a-413e-b19a-249ae42012a8.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 46708-478-31 | 46708047831 | 100 TABLET, FILM COATED in 1 BOTTLE (46708-478-31) | 2022-01-06 | 0000-00-00 | No | No | Current |
| 46708-478-91 | 46708047891 | 1000 TABLET, FILM COATED in 1 BOTTLE (46708-478-91) | 2022-01-06 | 0000-00-00 | No | No | Current |