Stalevo
- Product NDC
- 0078-0545
- 11-digit product format
- 000780545
- Labeler code
- 0078
- Product ID
- 0078-0545_ce712f44-166e-4abc-8326-529cb7cd0d8c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- carbidopa, levodopa, and entacapone
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Novartis Pharmaceuticals Corporation
- Application
- NDA021485
- Marketing category
- NDA
- Marketing start
- 2008-09-26
- Marketing end
- 2021-12-31
- 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 |
|---|
| 0078-0545-05 | 00078054505 | 100 TABLET, FILM COATED in 1 BOTTLE (0078-0545-05) | 2008-09-26 | 2021-12-31 | No | No | Current |