NDC 68382-474-30 - Pramipexole Dihydrochloride
This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.
- Product NDC
- 68382-474
- Requested NDC
- 68382-474-30
- Package NDCs from labels
- 68382-474-06, 68382-474-30, 68382-474-77
- Manufacturer
- Zydus Pharmaceuticals USA Inc. | Zydus Lifesciences Limited
- Effective date
- 2022-11-10
- Current FDA listing
- Not matched in FDA.report NDC product tables
DailyMed Labels#
| Label | Manufacturer | Effective date | Type |
|---|---|---|---|
| PRAMIPEXOLE - Zydus Pharmaceuticals USA Inc. | Zydus Lifesciences Limited | Zydus Pharmaceuticals USA Inc. | Zydus Lifesciences Limited | 2022-11-10 | HUMAN PRESCRIPTION DRUG LABEL |
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 | Unichem Pharmaceuticals (USA), Inc. | b978aa75-c62d-444b-9ec6-6c0d21a66688 | 2025-10-14 | Warnings, Adverse reactions | 3D867NP06J |
| Pramipexole Dihydrochloride | PRAMIPEXOLE DIHYDROCHLORIDE | Aurobindo Pharma Limited | 3f90971a-e005-4dd3-bb93-b09125ada3c8 | 2025-10-03 | Warnings, Adverse reactions | 3D867NP06J |
| Osmitrol | MANNITOL | Baxter Healthcare Company | 0d914965-7001-45cb-ba51-d7c5964b05bc | 2025-08-26 | Warnings, Adverse reactions | 3OWL53L36A |
| pramipexole dihydrochloride | PRAMIPEXOLE DIHYDROCHLORIDE | Strides Pharma Science Limited | fb2260d6-204c-4d25-a331-0f8340d83a6e | 2025-08-17 | Warnings, Adverse reactions | 3D867NP06J |
| Mannitol | MANNITOL | Henry Schein, Inc. | e2444db1-9dfe-451f-a33c-9b00786464d2 | 2025-05-20 | Warnings, Adverse reactions | 3OWL53L36A |
| fd74557e-8d4d-4963-9d45-51aacf68d0c1 | f48a60e8-3b4a-40fd-afdd-161e9b4f79f6 | 2025-05-05 | Warnings, Adverse reactions | f48a60e8-3b4a-40fd-afdd-161e9b4f79f6 | ||
| Pramipexole dihydrochloride | PRAMIPEXOLE DIHYDROCHLORIDE | Ingenus Pharmaceuticals, LLC | 1d2b1d2c-ae22-424a-bad7-ce24a817b042 | 2025-04-24 | Warnings, Adverse reactions | 3D867NP06J |
| Chemtox | TRITICUM AESTIVUM, BERBERIS VULGARIS, GLYCYRRHIZA GLABRA, LAPPA MAJOR, RHAMNUS FRANGULA, RHAMNUS PURSHIANA, STILLINGIA SYLVATICA, TRIFOLIUM PRATENSE, XANTHOXYLUM FRAXINEUM, PHYTOLACCA DECANDRA, GLANDULA SUPRARENALIS SUIS, HEPAR SUIS, LYMPH NODE (SUIS), THYROIDINUM (SUIS), BELLADONNA, LYCOPODIUM CLAVATUM, NITRICUM ACIDUM, NUX VOMICA, PHOSPHORICUM ACIDUM, PHOSPHORUS, SALICYLICUM ACIDUM, CORTISONE ACETICUM, EUGENOL, STEARYL ALCOHOL, XYLITOL, FOLLICULINUM, BENZOICUM ACIDUM, CHLORINUM, POTASSIUM SORBATE, | BioActive Nutritional, Inc. | a480e5f4-5f9e-4b23-b257-b0ac1ebfc115 | 2025-01-07 | Warnings | 2KR89I4H1Y |
| Chemtox | TRITICUM AESTIVUM, BERBERIS VULGARIS, GLYCYRRHIZA GLABRA, LAPPA MAJOR, RHAMNUS FRANGULA, RHAMNUS PURSHIANA, STILLINGIA SYLVATICA, TRIFOLIUM PRATENSE, XANTHOXYLUM FRAXINEUM, PHYTOLACCA DECANDRA, GLANDULA SUPRARENALIS SUIS, HEPAR SUIS, LYMPH NODE (SUIS), THYROIDINUM (SUIS), BELLADONNA, LYCOPODIUM CLAVATUM, NITRICUM ACIDUM, NUX VOMICA, PHOSPHORICUM ACIDUM, PHOSPHORUS, SALICYLICUM ACIDUM, CORTISONE ACETICUM, EUGENOL, STEARYL ALCOHOL, XYLITOL, FOLLICULINUM, BENZOICUM ACIDUM, CHLORINUM, POTASSIUM SORBATE, | BioActive Nutritional, Inc. | 9aa060f1-f8f6-46e6-a7d0-bd46a73f2676 | 2024-10-17 | Warnings | 2KR89I4H1Y |
| Pramipexole dihydrochloride | PRAMIPEXOLE DIHYDROCHLORIDE | NCS HealthCare of KY, LLC dba Vangard Labs | 5e6f2187-a5cc-481e-b0a1-d38d3f92e822 | 2024-10-09 | Warnings, Adverse reactions | 3D867NP06J |
| Pramipexole Dihydrochloride | PRAMIPEXOLE DIHYDROCHLORIDE | Bryant Ranch Prepack | 350a3f84-0f98-405f-bdae-6abbc47d48a4 | 2024-08-29 | Warnings, Adverse reactions | 3D867NP06J |
| Pramipexole Dihydrochloride | PRAMIPEXOLE DIHYDROCHLORIDE | NorthStar RxLLC | 946c8a72-8c48-4925-93d3-7940f4c0fd29 | 2024-08-20 | Warnings, Adverse reactions | 3D867NP06J |
| Pramipexole Dihydrochloride Extended-Release | PRAMIPEXOLE DIHYDROCHLORIDE | Vitruvias Therapeutics, Inc. | d07aad1b-e078-4fca-8386-ca2e8e899688 | 2024-07-23 | Warnings, Adverse reactions | 3D867NP06J |
| Pramipexole Dihydrochloride | PRAMIPEXOLE DIHYDROCHLORIDE | Macleods Pharmaceuticals Limited | 1dbb8d2f-e0d9-4f8b-89d2-2a03496ef7be | 2024-07-06 | Warnings, Adverse reactions | 3D867NP06J |
| Pramipexole Dihydrochloride | PRAMIPEXOLE DIHYDROCHLORIDE | Alembic Pharmaceuticals Inc. | e18b67b6-a085-43e5-bb2b-fe74fa00cb65 | 2024-06-20 | Warnings, Adverse reactions | 3D867NP06J |
| Pure Cornstarch Baby | CORN STARCH | Walgreen Company | d0e9bd13-b568-4f7e-b036-8d23e71ad8bf | 2024-03-25 | Warnings | O8232NY3SJ |
| MANNITOL | MANNITOL | HF Acquisition Co LLC, DBA HealthFirst | 999ce711-2d5b-0d7d-e053-2995a90a2689 | 2024-01-27 | Warnings, Adverse reactions | 3OWL53L36A |
| Pramipexole Dihydrochloride | PRAMIPEXOLE DIHYDROCHLORIDE | A-S Medication Solutions | 7cd6a546-d516-427c-af79-555390ccd35b | 2023-12-15 | Warnings, Adverse reactions | 3D867NP06J |
| Pramipexole Dihydrochloride | PRAMIPEXOLE DIHYDROCHLORIDE | Alembic Pharmaceuticals Limited | 0a3ed933-ef5b-4091-8ae9-5768ae18514f | 2023-12-08 | Warnings, Adverse reactions | 3D867NP06J |
| Lipotox | SQUALENE, CHOLESTERINUM, ESTRADIOL, PROGESTERONE, ASPARTAME, BENZALKONIUM CHLORIDE, FORMALINUM, METHYLENE CHLORIDE, METHYLPARABEN, PROPYLPARABEN, SODIUM BENZOATE, SODIUM CITRATE, TITANIUM DIOXIDE, ZINCUM OXYDATUM, ARSENICUM ALBUM, LYCOPODIUM CLAVATUM, NUX VOMICA, PHOSPHORICUM ACIDUM, PHOSPHORUS, ACETICUM ACIDUM, BENZOICUM ACIDUM, BENZYL ALCOHOL, BORICUM ACIDUM, CHLORINUM, CORTISONE ACETICUM, EUGENOL, FOLLICULINUM, ISOPROPYL PALMITATE, LACTICUM ACIDUM, PETROLEUM JELLY, PHENYL BUTAZONE, PLUMBUM METALLICUM, | BioActive Nutritional, Inc. | a1538692-ca00-4e52-9b7e-409767ee27e1 | 2023-09-05 | Warnings | 2KR89I4H1Y |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.