Entacapone
- Product NDC
- 64980-722
- 11-digit product format
- 649800722
- Labeler code
- 64980
- Product ID
- 64980-722_4f769e67-7f18-2066-e063-6294a90a0a99
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- entacapone
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Rising Pharma Holdings, Inc.
- Application
- ANDA206669
- Marketing category
- ANDA
- Marketing start
- 2026-04-23
- 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
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Entacapone
- Listing expiration
- 2027-12-31
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 |
|---|
| 64980-722-01 | Entacapone | 100 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 100 | | 1 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 64980-722-01 | 64980072201 | 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (64980-722-01) | 2026-04-23 | No | No | Current |