Mirapex
- Product NDC
- 0597-0101
- 11-digit product format
- 005970101
- Labeler code
- 0597
- Product ID
- 0597-0101_b530bc3b-69a8-a6a3-c79a-93714d39a718
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- pramipexole dihydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Boehringer Ingelheim Pharmaceuticals, Inc.
- Application
- NDA020667
- Marketing category
- NDA
- Marketing start
- 2007-10-01
- Marketing end
- 0000-00-00
- Substance
- PRAMIPEXOLE DIHYDROCHLORIDE
- Active strength
- 1 mg/1
- Pharmacologic classes
- Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2022-12-31
- Current FDA listing
- Historical FDA.report record
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0597-0101-90 | 00597010190 | 90 TABLET in 1 BOTTLE (0597-0101-90) | 90 tablet | 2007-10-01 | 0000-00-00 | No | No | Current |