NDC 69844-042

PRAMIPEXOLE DIHYDROCHLORIDE

Pramipexole Dihydrochloride

PRAMIPEXOLE DIHYDROCHLORIDE is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Graviti Pharmaceuticals Private Limited. The primary component is Pramipexole Dihydrochloride.

• Product ID: 69844-042_b8230032-fa60-4c04-b5e3-6544654cb5d6
• NDC: 69844-042
• Product Type: Human Prescription Drug
• Proprietary Name: PRAMIPEXOLE DIHYDROCHLORIDE
• Generic Name: Pramipexole Dihydrochloride
• Dosage Form: Tablet
• Route of Administration: ORAL
• Marketing Start Date: 2020-04-06
• Marketing Category: ANDA / ANDA
• Application Number: ANDA211088
• Labeler Name: Graviti Pharmaceuticals Private Limited
• Substance Name: PRAMIPEXOLE DIHYDROCHLORIDE
• Active Ingredient Strength: 0 mg/1
• Pharm Classes: Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2021-12-31

Packaging

NDC 69844-042-01

90 TABLET in 1 BOTTLE (69844-042-01)

• Marketing Start Date: 2020-04-06
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 69844-042-01 [69844004201]

PRAMIPEXOLE DIHYDROCHLORIDE TABLET

• Marketing Category: ANDA
• Application Number: ANDA211088
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2020-04-06

Drug Details

Active Ingredients

Ingredient	Strength
PRAMIPEXOLE DIHYDROCHLORIDE	.25 mg/1

OpenFDA Data

• SPL SET ID: 85c8649f-2bde-4bb8-9f57-f609934346d1
• Manufacturer:
  • Graviti Pharmaceuticals Private Limited
• UNII:
  • 3D867NP06J
• RxNorm Concept Unique ID - RxCUI:
  • 859040
  • 859048
  • 858625
  • 859044
  • 859052

Pharmacological Class

• Dopamine Agonists [MoA]
• Nonergot Dopamine Agonist [EPC]

NDC Crossover Matching brand name "PRAMIPEXOLE DIHYDROCHLORIDE" or generic name "Pramipexole Dihydrochloride"

NDC	Brand Name	Generic Name
68084-793	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride
68084-982	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride
68084-440	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride
68084-974	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride
68151-3966	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride
68151-0329	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride
68151-3645	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride
68382-196	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride
68382-198	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride
68382-199	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride
68382-475	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride
68382-200	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride
68382-476	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride
68382-875	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride
68382-477	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride
68382-197	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride
68382-474	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride
68382-478	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride
68382-874	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride
68462-627	Pramipexole dihydrochloride	Pramipexole dihydrochloride
68462-330	Pramipexole dihydrochloride	Pramipexole dihydrochloride
68462-332	Pramipexole dihydrochloride	Pramipexole dihydrochloride
68462-334	Pramipexole dihydrochloride	Pramipexole dihydrochloride
68462-333	Pramipexole dihydrochloride	Pramipexole dihydrochloride
68462-331	Pramipexole dihydrochloride	Pramipexole dihydrochloride
70771-1330	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride
70771-1333	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride
70771-1329	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride
70771-1334	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride
70771-1328	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride
70771-1331	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride
70771-1332	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride
71335-0584	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride
0615-7597	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride
0781-5249	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride
0781-5248	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride
0781-5252	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride
0781-5281	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride
0781-5250	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride
0781-5251	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride
13668-095	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride
13668-184	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride
13668-092	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride
13668-091	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride
13668-094	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride
13668-093	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride
16714-920	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride
16714-916	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride
16714-922	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride
16714-918	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride