Pramipexole Dihydrochloride
- Product NDC
- 68382-476
- 11-digit product format
- 683820476
- Labeler code
- 68382
- Product ID
- 68382-476_4c93c76b-c6af-4d4c-b8b6-c5bc60829ae5
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Pramipexole Dihydrochloride
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Zydus Pharmaceuticals USA Inc.
- Application
- ANDA202891
- Marketing category
- ANDA
- Marketing start
- 2018-04-24
- Marketing end
- 0000-00-00
- Substance
- PRAMIPEXOLE DIHYDROCHLORIDE
- Active strength
- 2 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 | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 68382-476-06 | 68382047606 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (68382-476-06) | | 2018-04-24 | 0000-00-00 | No | No | Current |
| 68382-476-77 | 68382047677 | 10 BLISTER PACK in 1 CARTON (68382-476-77) > 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (68382-476-30) | 10 blister pack | 2018-04-24 | 0000-00-00 | No | No | Current |