Entacapone
- Product NDC
- 60687-188
- 11-digit product format
- 606870188
- Labeler code
- 60687
- Product ID
- 60687-188_1a3aa5b4-7f0b-4140-e063-6394a90a3282
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Entacapone
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- American Health Packaging
- Application
- ANDA203437
- Marketing category
- ANDA
- Marketing start
- 2016-06-02
- 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 |
|---|
| 60687-188-11 | Entacapone | 1 in 1 BLISTER PACK | TABLET, FILM COATED | 1 | | 8 |
| 60687-188-21 | Entacapone | 30 in 1 BOX, UNIT-DOSE | TABLET, FILM COATED | 30 | | 8 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 60687-188 | ENTACAPONE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] | 8 | Current NDC, Legacy NDC, 2 package rows | 20240608_3d4ec829-7835-4d59-bc5b-6ce38811fba7.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 |
|---|
| 60687-188-11 | 60687018811 | 1 in 1 BLISTER PACK | | | | | | Historical |
| 60687-188-21 | 60687018821 | 30 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-188-21) / 1 TABLET, FILM COATED in 1 BLISTER PACK (60687-188-11) | 30 blister pack | 2016-06-02 | 0000-00-00 | No | No | Current |