pramipexole dihydrochloride
- Product NDC
- 64380-750
- 11-digit product format
- 643800750
- Labeler code
- 64380
- Product ID
- 64380-750_94664b38-edd0-4181-8eb2-8bbd9aa3a451
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- pramipexole dihydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Strides Pharma Science Limited
- Application
- ANDA202702
- Marketing category
- ANDA
- Marketing start
- 2021-02-15
- Substance
- PRAMIPEXOLE DIHYDROCHLORIDE
- Active strength
- 1 mg/1
- Pharmacologic classes
- Dopamine Agonists [MoA], Nonergot Dopamine Agonist [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- pramipexole dihydrochloride
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| PRAMIPEXOLE DIHYDROCHLORIDE | 1 mg/1 |
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 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 64380-750-01 | pramipexole dihydrochloride | 10 in 1 CARTON | TABLET | 10 | 10 | |
| 64380-750-01 | pramipexole dihydrochloride | 10 in 1 BLISTER PACK | TABLET | 10 | 10 | |
| 64380-750-05 | pramipexole dihydrochloride | 90 in 1 BOTTLE | TABLET | 90 | 10 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 64380-750-05 | EA - Each | 64380-750 | e2576531-7f43-43f3-8d3d-39bc2dd14832 | 1 | 2021-03-02 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| PRAMIPEXOLE DIHYDROCHLORIDE | ACTIVE INGREDIENT | 3D867NP06J | PRAMIPEXOLE DIHYDROCHLORIDE TABLET [STRIDES ARCOLAB LIMITED] | 3 | |
| PRAMIPEXOLE | ACTIVE MOIETY | 83619PEU5T | PRAMIPEXOLE DIHYDROCHLORIDE TABLET [STRIDES ARCOLAB LIMITED] | 3 | |
| COLLOIDAL SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | PRAMIPEXOLE DIHYDROCHLORIDE TABLET [STRIDES ARCOLAB LIMITED] | 3 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | PRAMIPEXOLE DIHYDROCHLORIDE TABLET [STRIDES ARCOLAB LIMITED] | 3 | |
| MANNITOL | INACTIVE INGREDIENT | 3OWL53L36A | PRAMIPEXOLE DIHYDROCHLORIDE TABLET [STRIDES ARCOLAB LIMITED] | 3 | |
| POVIDONE | INACTIVE INGREDIENT | FZ989GH94E | PRAMIPEXOLE DIHYDROCHLORIDE TABLET [STRIDES ARCOLAB LIMITED] | 3 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | PRAMIPEXOLE DIHYDROCHLORIDE TABLET [STRIDES ARCOLAB LIMITED] | 3 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 859033 | pramipexole dihydrochloride 0.125 MG Oral Tablet | PSN | fb2260d6-204c-4d25-a331-0f8340d83a6e | 10 |
| 859040 | pramipexole dihydrochloride 0.25 MG Oral Tablet | PSN | fb2260d6-204c-4d25-a331-0f8340d83a6e | 10 |
| 859044 | pramipexole dihydrochloride 0.5 MG Oral Tablet | PSN | fb2260d6-204c-4d25-a331-0f8340d83a6e | 10 |
| 858625 | pramipexole dihydrochloride 0.75 MG Oral Tablet | PSN | fb2260d6-204c-4d25-a331-0f8340d83a6e | 10 |
| 859052 | pramipexole dihydrochloride 1 MG Oral Tablet | PSN | fb2260d6-204c-4d25-a331-0f8340d83a6e | 10 |
| 859048 | pramipexole dihydrochloride 1.5 MG Oral Tablet | PSN | fb2260d6-204c-4d25-a331-0f8340d83a6e | 10 |
| 859033 | pramipexole dihydrochloride 0.125 MG Oral Tablet | SCD | fb2260d6-204c-4d25-a331-0f8340d83a6e | 10 |
| 859040 | pramipexole dihydrochloride 0.25 MG Oral Tablet | SCD | fb2260d6-204c-4d25-a331-0f8340d83a6e | 10 |
| 859044 | pramipexole dihydrochloride 0.5 MG Oral Tablet | SCD | fb2260d6-204c-4d25-a331-0f8340d83a6e | 10 |
| 858625 | pramipexole dihydrochloride 0.75 MG Oral Tablet | SCD | fb2260d6-204c-4d25-a331-0f8340d83a6e | 10 |
| 859052 | pramipexole dihydrochloride 1 MG Oral Tablet | SCD | fb2260d6-204c-4d25-a331-0f8340d83a6e | 10 |
| 859048 | pramipexole dihydrochloride 1.5 MG Oral Tablet | SCD | fb2260d6-204c-4d25-a331-0f8340d83a6e | 10 |
| 859033 | pramipexole dihydrochloride 0.125 MG (pramipexole 0.088 MG) Oral Tablet | SY | fb2260d6-204c-4d25-a331-0f8340d83a6e | 10 |
| 859040 | pramipexole dihydrochloride 0.25 MG (pramipexole 0.18 MG) Oral Tablet | SY | fb2260d6-204c-4d25-a331-0f8340d83a6e | 10 |
| 859044 | pramipexole dihydrochloride 0.5 MG (pramipexole 0.35 MG) Oral Tablet | SY | fb2260d6-204c-4d25-a331-0f8340d83a6e | 10 |
| 858625 | pramipexole dihydrochloride 0.75 MG (pramipexole 0.525 MG) Oral Tablet | SY | fb2260d6-204c-4d25-a331-0f8340d83a6e | 10 |
| 859052 | pramipexole dihydrochloride 1 MG (pramipexole 0.7 MG) Oral Tablet | SY | fb2260d6-204c-4d25-a331-0f8340d83a6e | 10 |
| 859048 | pramipexole dihydrochloride 1.5 MG (equivalent to pramipexole 1 MG) Oral Tablet | SY | fb2260d6-204c-4d25-a331-0f8340d83a6e | 10 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 64380-750-01 | 64380075001 | 10 BLISTER PACK in 1 CARTON (64380-750-01) / 10 TABLET in 1 BLISTER PACK | 10 blister pack | 2021-02-15 | 0000-00-00 | No | No | Current |
| 64380-750-05 | 64380075005 | 90 TABLET in 1 BOTTLE (64380-750-05) | 90 tablet | 2021-02-15 | 0000-00-00 | No | No | Current |