Carbidopa, Levodopa and Entacapone
- Product NDC
- 0378-8300
- 11-digit product format
- 003788300
- Labeler code
- 0378
- Product ID
- 0378-8300_faf9e791-38ce-41a4-bab9-ee1aa6e4ff2a
- 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
- 2015-02-12
- Marketing end
- 0000-00-00
- Substance
- CARBIDOPA; LEVODOPA; ENTACAPONE
- Active strength
- 13 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
- 2020-12-31
- 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 |
|---|
| 0378-8300-01 | 00378830001 | 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-8300-01) | 2015-02-12 | 0000-00-00 | No | No | Current |