Pramipexole Dihydrochloride
- Product NDC
- 63629-5042
- 11-digit product format
- 636295042
- Labeler code
- 63629
- Product ID
- 63629-5042_c2a84c54-b4d7-4989-9bb9-21a523d0a938
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Pramipexole Dihydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA090865
- Marketing category
- ANDA
- Marketing start
- 2010-10-08
- Substance
- PRAMIPEXOLE DIHYDROCHLORIDE
- Active strength
- .125 mg/1
- Pharmacologic classes
- Dopamine Agonists [MoA], Nonergot Dopamine Agonist [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A090865-001 | PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | 0.125MG | TABLET / ORAL | AB | 2010-10-08 | |
| A090865-002 | PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | 0.25MG | TABLET / ORAL | AB | 2010-10-08 | |
| A090865-003 | PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | 0.5MG | TABLET / ORAL | AB | 2010-10-08 | |
| A090865-004 | PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | 0.75MG | TABLET / ORAL | AB | 2010-10-08 | |
| A090865-005 | PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | 1MG | TABLET / ORAL | AB | 2010-10-08 | |
| A090865-006 | PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | 1.5MG | TABLET / ORAL | AB | 2010-10-08 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A090865-001 | AB |
| A090865-002 | AB |
| A090865-003 | AB |
| A090865-004 | AB |
| A090865-005 | AB |
| A090865-006 | AB |
Observed Orange Book product history#
Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A090865-001 | PRAMIPEXOLE DIHYDROCHLORIDE | 0.125MG | TABLET / ORAL | AB | 2010-10-08 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A090865-002 | PRAMIPEXOLE DIHYDROCHLORIDE | 0.25MG | TABLET / ORAL | AB | 2010-10-08 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A090865-003 | PRAMIPEXOLE DIHYDROCHLORIDE | 0.5MG | TABLET / ORAL | AB | 2010-10-08 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A090865-004 | PRAMIPEXOLE DIHYDROCHLORIDE | 0.75MG | TABLET / ORAL | AB | 2010-10-08 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A090865-005 | PRAMIPEXOLE DIHYDROCHLORIDE | 1MG | TABLET / ORAL | AB | 2010-10-08 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A090865-006 | PRAMIPEXOLE DIHYDROCHLORIDE | 1.5MG | TABLET / ORAL | AB | 2010-10-08 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090865-001 | PRAMIPEXOLE DIHYDROCHLORIDE | 0.125MG | TABLET / ORAL | AB | 2010-10-08 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090865-002 | PRAMIPEXOLE DIHYDROCHLORIDE | 0.25MG | TABLET / ORAL | AB | 2010-10-08 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090865-003 | PRAMIPEXOLE DIHYDROCHLORIDE | 0.5MG | TABLET / ORAL | AB | 2010-10-08 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090865-004 | PRAMIPEXOLE DIHYDROCHLORIDE | 0.75MG | TABLET / ORAL | AB | 2010-10-08 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090865-005 | PRAMIPEXOLE DIHYDROCHLORIDE | 1MG | TABLET / ORAL | AB | 2010-10-08 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090865-006 | PRAMIPEXOLE DIHYDROCHLORIDE | 1.5MG | TABLET / ORAL | AB | 2010-10-08 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A090865-001 | PRAMIPEXOLE DIHYDROCHLORIDE | 0.125MG | TABLET / ORAL | AB | 2010-10-08 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A090865-002 | PRAMIPEXOLE DIHYDROCHLORIDE | 0.25MG | TABLET / ORAL | AB | 2010-10-08 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A090865-003 | PRAMIPEXOLE DIHYDROCHLORIDE | 0.5MG | TABLET / ORAL | AB | 2010-10-08 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A090865-004 | PRAMIPEXOLE DIHYDROCHLORIDE | 0.75MG | TABLET / ORAL | AB | 2010-10-08 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A090865-005 | PRAMIPEXOLE DIHYDROCHLORIDE | 1MG | TABLET / ORAL | AB | 2010-10-08 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A090865-006 | PRAMIPEXOLE DIHYDROCHLORIDE | 1.5MG | TABLET / ORAL | AB | 2010-10-08 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090865-001 | PRAMIPEXOLE DIHYDROCHLORIDE | 0.125MG | TABLET / ORAL | AB | 2010-10-08 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090865-002 | PRAMIPEXOLE DIHYDROCHLORIDE | 0.25MG | TABLET / ORAL | AB | 2010-10-08 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090865-003 | PRAMIPEXOLE DIHYDROCHLORIDE | 0.5MG | TABLET / ORAL | AB | 2010-10-08 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090865-004 | PRAMIPEXOLE DIHYDROCHLORIDE | 0.75MG | TABLET / ORAL | AB | 2010-10-08 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090865-005 | PRAMIPEXOLE DIHYDROCHLORIDE | 1MG | TABLET / ORAL | AB | 2010-10-08 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090865-006 | PRAMIPEXOLE DIHYDROCHLORIDE | 1.5MG | TABLET / ORAL | AB | 2010-10-08 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090865-001 | PRAMIPEXOLE DIHYDROCHLORIDE | 0.125MG | TABLET / ORAL | AB | 2010-10-08 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090865-002 | PRAMIPEXOLE DIHYDROCHLORIDE | 0.25MG | TABLET / ORAL | AB | 2010-10-08 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090865-003 | PRAMIPEXOLE DIHYDROCHLORIDE | 0.5MG | TABLET / ORAL | AB | 2010-10-08 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090865-004 | PRAMIPEXOLE DIHYDROCHLORIDE | 0.75MG | TABLET / ORAL | AB | 2010-10-08 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090865-005 | PRAMIPEXOLE DIHYDROCHLORIDE | 1MG | TABLET / ORAL | AB | 2010-10-08 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090865-006 | PRAMIPEXOLE DIHYDROCHLORIDE | 1.5MG | TABLET / ORAL | AB | 2010-10-08 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090865-001 | PRAMIPEXOLE DIHYDROCHLORIDE | 0.125MG | TABLET / ORAL | AB | 2010-10-08 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090865-002 | PRAMIPEXOLE DIHYDROCHLORIDE | 0.25MG | TABLET / ORAL | AB | 2010-10-08 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090865-003 | PRAMIPEXOLE DIHYDROCHLORIDE | 0.5MG | TABLET / ORAL | AB | 2010-10-08 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090865-004 | PRAMIPEXOLE DIHYDROCHLORIDE | 0.75MG | TABLET / ORAL | AB | 2010-10-08 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090865-005 | PRAMIPEXOLE DIHYDROCHLORIDE | 1MG | TABLET / ORAL | AB | 2010-10-08 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090865-006 | PRAMIPEXOLE DIHYDROCHLORIDE | 1.5MG | TABLET / ORAL | AB | 2010-10-08 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090865-001 | PRAMIPEXOLE DIHYDROCHLORIDE | 0.125MG | TABLET / ORAL | AB | 2010-10-08 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090865-002 | PRAMIPEXOLE DIHYDROCHLORIDE | 0.25MG | TABLET / ORAL | AB | 2010-10-08 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090865-003 | PRAMIPEXOLE DIHYDROCHLORIDE | 0.5MG | TABLET / ORAL | AB | 2010-10-08 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090865-004 | PRAMIPEXOLE DIHYDROCHLORIDE | 0.75MG | TABLET / ORAL | AB | 2010-10-08 | 2680178bc6a6… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A090865-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A090865-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A090865-003 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A090865-004 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A090865-005 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A090865-006 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090865-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090865-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090865-003 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090865-004 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090865-005 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090865-006 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A090865-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A090865-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A090865-003 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A090865-004 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A090865-005 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A090865-006 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090865-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090865-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090865-003 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090865-004 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090865-005 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090865-006 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090865-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090865-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090865-003 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090865-004 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090865-005 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090865-006 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090865-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090865-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090865-003 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090865-004 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090865-005 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090865-006 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090865-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090865-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090865-003 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090865-004 | AB | 1 | 2680178bc6a6… |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Pramipexole Dihydrochloride
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| PRAMIPEXOLE DIHYDROCHLORIDE | .125 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 3D867NP06J | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 859033 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| bd0f7ae1-11ef-4fab-894f-c4c59f75aa99 | Available on FDA.report |
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 |
|---|---|---|---|---|---|---|
| 63629-5042-1 | Pramipexole Dihydrochloride | 30 in 1 BOTTLE | TABLET | 30 | 1014 | |
| 63629-5042-2 | Pramipexole Dihydrochloride | 60 in 1 BOTTLE | TABLET | 60 | 1014 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 63629-5042-1 | EA - Each | 63629-5042 | f916496b-434d-4032-ac92-89a4dcac4940 | 1 | 2019-11-12 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| PRAMIPEXOLE DIHYDROCHLORIDE | ACTIVE INGREDIENT | 3D867NP06J | PRAMIPEXOLE DIHYDROCHLORIDE TABLET [BRYANT RANCH PREPACK] | 1000 | |
| PRAMIPEXOLE | ACTIVE MOIETY | 83619PEU5T | PRAMIPEXOLE DIHYDROCHLORIDE TABLET [BRYANT RANCH PREPACK] | 1000 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | PRAMIPEXOLE DIHYDROCHLORIDE TABLET [BRYANT RANCH PREPACK] | 1000 | |
| MANNITOL | INACTIVE INGREDIENT | 3OWL53L36A | PRAMIPEXOLE DIHYDROCHLORIDE TABLET [BRYANT RANCH PREPACK] | 1000 | |
| POVIDONE K30 | INACTIVE INGREDIENT | U725QWY32X | PRAMIPEXOLE DIHYDROCHLORIDE TABLET [BRYANT RANCH PREPACK] | 1000 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | PRAMIPEXOLE DIHYDROCHLORIDE TABLET [BRYANT RANCH PREPACK] | 1000 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | PRAMIPEXOLE DIHYDROCHLORIDE TABLET [BRYANT RANCH PREPACK] | 1000 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 63629-5042 | PRAMIPEXOLE DIHYDROCHLORIDE TABLET [BRYANT RANCH PREPACK] | 1013 | Current NDC, Legacy NDC, 2 package rows | 20240912_bd0f7ae1-11ef-4fab-894f-c4c59f75aa99.zip |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Pramipexole Dihydrochloride | PRAMIPEXOLE DIHYDROCHLORIDE | Bryant Ranch Prepack | 46f88017-7b0e-437e-90b1-37bdf9013e72 | 2026-05-22 | Warnings, Adverse reactions | 090865 ANDA090865 |
| Pramipexole Dihydrochloride | PRAMIPEXOLE DIHYDROCHLORIDE | A-S Medication Solutions | 3db0613d-524b-4b33-9a07-602f84d6c304 | 2026-04-26 | Warnings, Adverse reactions | 090865 ANDA090865 |
| Pramipexole Dihydrochloride | PRAMIPEXOLE DIHYDROCHLORIDE | Bryant Ranch Prepack | bd0f7ae1-11ef-4fab-894f-c4c59f75aa99 | 2026-04-03 | Warnings, Adverse reactions | 090865 ANDA090865 63629-5042 |
| Pramipexole Dihydrochloride | PRAMIPEXOLE DIHYDROCHLORIDE | Bryant Ranch Prepack | dd4b4e2a-97b5-417d-bb90-bec692dc359b | 2026-04-02 | Warnings, Adverse reactions | 090865 ANDA090865 |
| Pramipexole Dihydrochloride | PRAMIPEXOLE DIHYDROCHLORIDE | Torrent Pharmaceuticals Limited | 60167d7c-469f-455a-a113-561841af5e59 | 2026-03-31 | Warnings, Adverse reactions | 090865 ANDA090865 |
| Pramipexole Dihydrochloride | PRAMIPEXOLE DIHYDROCHLORIDE | American Health Packaging | f4d97c2e-f447-4cfe-b9d4-852323f0cfb5 | 2026-03-03 | Warnings, Adverse reactions | 090865 ANDA090865 |
| Pramipexole Dihydrochloride | PRAMIPEXOLE DIHYDROCHLORIDE | Major Pharmaceuticals | 978c0e89-35f0-44a2-9302-8bed7e5d60e0 | 2026-01-21 | Warnings, Adverse reactions | 090865 ANDA090865 |
| Pramipexole Dihydrochloride | PRAMIPEXOLE DIHYDROCHLORIDE | Bryant Ranch Prepack | 794fdab8-1c15-4469-963e-4f9e3495536f | 2025-11-17 | Warnings, Adverse reactions | 090865 ANDA090865 |
| Pramipexole Dihydrochloride | PRAMIPEXOLE DIHYDROCHLORIDE | Bryant Ranch Prepack | 350a3f84-0f98-405f-bdae-6abbc47d48a4 | 2024-08-29 | Warnings, Adverse reactions | 090865 ANDA090865 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 859033 | pramipexole dihydrochloride 0.125 MG Oral Tablet | PSN | bd0f7ae1-11ef-4fab-894f-c4c59f75aa99 | 1014 |
| 859033 | pramipexole dihydrochloride 0.125 MG Oral Tablet | SCD | bd0f7ae1-11ef-4fab-894f-c4c59f75aa99 | 1014 |
| 859033 | pramipexole dihydrochloride 0.125 MG (pramipexole 0.088 MG) Oral Tablet | SY | bd0f7ae1-11ef-4fab-894f-c4c59f75aa99 | 1014 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 63629-5042-1 | 63629504201 | 30 TABLET in 1 BOTTLE (63629-5042-1) | 30 tablet | 2013-07-16 | 0000-00-00 | No | No | Current |
| 63629-5042-2 | 63629504202 | 60 TABLET in 1 BOTTLE (63629-5042-2) | 60 tablet | 2013-09-10 | 0000-00-00 | No | No | Current |