Entacapone
- Product NDC
- 0527-1830
- 11-digit product format
- 005271830
- Labeler code
- 0527
- Product ID
- 0527-1830_071b5720-d208-9e0e-e063-6294a90a0513
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- entacapone
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Lannett Company, Inc.
- Application
- ANDA206669
- Marketing category
- ANDA
- Marketing start
- 2018-12-20
- 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 |
|---|
| 0527-1830-35 | Entacapone | 60 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 60 | | 5 |
| 0527-1830-37 | Entacapone | 100 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 100 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0527-1830 | ENTACAPONE TABLET, FILM COATED [LANNETT COMPANY, INC.] | 5 | Current NDC, Legacy NDC, 2 package rows | 20231007_0bf133e4-1c17-4358-9a43-144e6bf2564f.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 |
|---|
| 0527-1830-35 | 00527183035 | 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0527-1830-35) | 2018-12-20 | 0000-00-00 | No | No | Current |
| 0527-1830-37 | 00527183037 | 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0527-1830-37) | 2018-12-20 | 0000-00-00 | No | No | Current |