Entacapone
- Product NDC
- 33342-260
- 11-digit product format
- 333420260
- Labeler code
- 33342
- Product ID
- 33342-260_000701ed-32a2-4b57-acb3-41c3b5ad869e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Entacapone
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Macleods Pharmaceuticals Limited
- 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
- 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 |
|---|
| 33342-260-11 | Entacapone | 100 in 1 BOTTLE | TABLET | 100 | | 7 |
| 33342-260-15 | Entacapone | 500 in 1 BOTTLE | TABLET | 500 | | 7 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 33342-260 | ENTACAPONE TABLET [MACLEODS PHARMACEUTICALS LIMITED] | 6 | Current NDC, Legacy NDC, 2 package rows | 20250121_56327e32-3b06-4144-91a0-bb1908842e33.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 |
|---|
| 33342-260-11 | 33342026011 | 100 TABLET in 1 BOTTLE (33342-260-11) | 100 tablet | 2017-06-06 | 0000-00-00 | No | No | Current |
| 33342-260-15 | 33342026015 | 500 TABLET in 1 BOTTLE (33342-260-15) | 500 tablet | 2017-06-06 | 0000-00-00 | No | No | Current |