Mirapex
- Product NDC
- 21695-867
- 11-digit product format
- 216950867
- Labeler code
- 21695
- Product ID
- 21695-867_b5504316-3907-444c-b604-ec9a18cdcd6d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- pramipexole dihydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Rebel Distributors Corp
- Application
- NDA020667
- Marketing category
- NDA
- Marketing start
- 2004-01-01
- 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
- E
- Listing certified through
- 2017-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| a67b8488-0225-64b1-be81-5cbe60d285a5 | Product name | 9 | 20221116 |
| 3863aae0-7028-3427-389e-3f6c8692e587 | Product name | 3 | 20190117 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 21695-867-90 | 2019-09-24 | C162847 | 48780-1 | 934fe258-488d-48b1-e053-8cdaa90a720a | Mirapex ® (pramipexole dihydrochloride) 0.125 mg, 0.25 mg, 0.5 mg, 0.75 mg, 1 mg, and 1.5 mg Tablets |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 21695-867-90 | Mirapex | 90 in 1 BOTTLE | TABLET | 90 | 1 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 21695-867-90 | EA - Each | 21695-867 | aaa971d3-7afb-40cc-8f71-22cedeb6a7cb | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| pramipexole dihydrochloride | ACTIVE INGREDIENT | 3D867NP06J | MIRAPEX (PRAMIPEXOLE DIHYDROCHLORIDE) TABLET [REBEL DISTRIBUTORS CORP] | 1 | |
| pramipexole | ACTIVE MOIETY | 83619PEU5T | MIRAPEX (PRAMIPEXOLE DIHYDROCHLORIDE) TABLET [REBEL DISTRIBUTORS CORP] | 1 | |
| colloidal silicon dioxide | INACTIVE INGREDIENT | ETJ7Z6XBU4 | MIRAPEX (PRAMIPEXOLE DIHYDROCHLORIDE) TABLET [REBEL DISTRIBUTORS CORP] | 1 | |
| magnesium stearate | INACTIVE INGREDIENT | 70097M6I30 | MIRAPEX (PRAMIPEXOLE DIHYDROCHLORIDE) TABLET [REBEL DISTRIBUTORS CORP] | 1 | |
| mannitol | INACTIVE INGREDIENT | 3OWL53L36A | MIRAPEX (PRAMIPEXOLE DIHYDROCHLORIDE) TABLET [REBEL DISTRIBUTORS CORP] | 1 | |
| povidone | INACTIVE INGREDIENT | FZ989GH94E | MIRAPEX (PRAMIPEXOLE DIHYDROCHLORIDE) TABLET [REBEL DISTRIBUTORS CORP] | 1 | |
| starch, corn | INACTIVE INGREDIENT | O8232NY3SJ | MIRAPEX (PRAMIPEXOLE DIHYDROCHLORIDE) TABLET [REBEL DISTRIBUTORS CORP] | 1 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 859046 | Mirapex 0.5 MG Oral Tablet | PSN | b5504316-3907-444c-b604-ec9a18cdcd6d | 1 |
| 859044 | pramipexole dihydrochloride 0.5 MG Oral Tablet | PSN | b5504316-3907-444c-b604-ec9a18cdcd6d | 1 |
| 859046 | pramipexole dihydrochloride 0.5 MG Oral Tablet [Mirapex] | SBD | b5504316-3907-444c-b604-ec9a18cdcd6d | 1 |
| 859044 | pramipexole dihydrochloride 0.5 MG Oral Tablet | SCD | b5504316-3907-444c-b604-ec9a18cdcd6d | 1 |
| 859046 | Mirapex 0.5 MG Oral Tablet | SY | b5504316-3907-444c-b604-ec9a18cdcd6d | 1 |
| 859044 | pramipexole dihydrochloride 0.5 MG (pramipexole 0.35 MG) Oral Tablet | SY | b5504316-3907-444c-b604-ec9a18cdcd6d | 1 |
Packages#
| Package NDC | 11-digit format | Description | Status |
|---|---|---|---|
| 21695-867-90 | 21695086790 | 90 in 1 BOTTLE | Historical |