Entacapone
- Product NDC
- 0378-9080
- 11-digit product format
- 003789080
- Labeler code
- 0378
- Product ID
- 0378-9080_f4289356-c830-4fb7-b3c8-94ea6f2f1695
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Entacapone
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Mylan Pharmaceuticals Inc.
- Application
- NDA020796
- Marketing category
- NDA AUTHORIZED GENERIC
- Marketing start
- 2013-06-26
- Marketing end
- 2022-08-31
- 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
- 0000-00-00
- Current FDA listing
- Historical FDA.report record
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0378-9080-01 | 00378908001 | 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-9080-01) | 2013-06-26 | 0000-00-00 | No | No | Current |