Mirapex
- Product NDC
- 0597-0116
- 11-digit product format
- 005970116
- Labeler code
- 0597
- Product ID
- 0597-0116_52132628-35e3-4594-a642-da7162158112
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- pramipexole dihydrochloride
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Boehringer Ingelheim Pharmaceuticals, Inc.
- Application
- NDA022421
- Marketing category
- NDA
- Marketing start
- 2010-02-22
- Marketing end
- 0000-00-00
- Substance
- PRAMIPEXOLE DIHYDROCHLORIDE
- Active strength
- 5 mg/1
- Pharmacologic classes
- Dopamine Agonists [MoA], Nonergot Dopamine Agonist [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- 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 |
|---|
| 0597-0116-30 | 00597011630 | 1 BOTTLE, PLASTIC in 1 CARTON (0597-0116-30) > 30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC | 2010-02-22 | 0000-00-00 | No | No | Current |