Carbidopa, Levodopa and Entacapone
- Product NDC
- 0378-8303
- 11-digit product format
- 003788303
- Labeler code
- 0378
- Product ID
- 0378-8303_4c9f9e95-49dd-4da6-8dd1-5caba49cce1c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- carbidopa, levodopa and entacapone
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Mylan Pharmaceuticals Inc.
- Application
- NDA021485
- Marketing category
- NDA AUTHORIZED GENERIC
- Marketing start
- 2013-10-28
- Marketing end
- 2022-02-28
- Substance
- CARBIDOPA; LEVODOPA; ENTACAPONE
- Active strength
- 31 mg/1; mg/1; mg/1
- Pharmacologic classes
- Aromatic Amino Acid [EPC],Amino Acids, Aromatic [CS],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 |
|---|
| 0378-8303-01 | 00378830301 | 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-8303-01) | 2013-10-28 | 2022-02-28 | No | No | Current |