Entacapone
- Product NDC
- 0615-8298
- 11-digit product format
- 006158298
- Labeler code
- 0615
- Product ID
- 0615-8298_8a8a753b-0535-46cc-9f01-357510f4e9f0
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Entacapone
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- NCS HealthCare of KY, LLC dba Vangard Labs
- Application
- ANDA207210
- Marketing category
- ANDA
- Marketing start
- 2017-06-06
- 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 |
|---|
| 0615-8298-39 | Entacapone | 30 in 1 BLISTER PACK | TABLET | 30 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0615-8298 | ENTACAPONE TABLET [NCS HEALTHCARE OF KY, LLC DBA VANGARD LABS] | 5 | Current NDC, Legacy NDC, 1 package rows | 20241025_bff19d15-c57b-4a40-bba4-1e0a85fd09c5.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 |
|---|
| 0615-8298-39 | 00615829839 | 30 TABLET in 1 BLISTER PACK (0615-8298-39) | 30 tablet | 2019-07-01 | 0000-00-00 | No | No | Current |