Pramipexole Dihydrochloride
- Product NDC
- 10370-305
- 11-digit product format
- 103700305
- Labeler code
- 10370
- Product ID
- 10370-305_4b42cbf3-6700-4c2d-95a2-edb74067858a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Pramipexole
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Par Pharmaceutical, Inc.
- Application
- ANDA202206
- Marketing category
- ANDA
- Marketing start
- 2015-11-20
- Marketing end
- 2023-07-31
- Substance
- PRAMIPEXOLE DIHYDROCHLORIDE
- Active strength
- 2 mg/1
- Pharmacologic classes
- Dopamine Agonists [MoA], Nonergot Dopamine Agonist [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 |
|---|
| 10370-305-11 | 10370030511 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (10370-305-11) | 2015-11-20 | 2023-07-31 | No | No | Current |