NDC 65841-734

PRAMIPEXOLE DIHYDROCHLORIDE

Pramipexole Dihydrochloride

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

• Product ID: 65841-734_45a8b1f5-90da-46df-9f01-2f174331f3e8
• NDC: 65841-734
• Product Type: Human Prescription Drug
• Proprietary Name: PRAMIPEXOLE DIHYDROCHLORIDE
• Generic Name: Pramipexole Dihydrochloride
• Dosage Form: Tablet
• Route of Administration: ORAL
• Marketing Start Date: 2010-07-10
• Marketing Category: ANDA / ANDA
• Application Number: ANDA078920
• Labeler Name: Zydus Lifesciences 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: 2023-12-31

Packaging

NDC 65841-734-05

500 TABLET in 1 BOTTLE (65841-734-05)

• Marketing Start Date: 2010-07-10
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 65841-734-05 [65841073405]

PRAMIPEXOLE DIHYDROCHLORIDE TABLET

• Marketing Category: ANDA
• Application Number: ANDA078920
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2010-07-10

NDC 65841-734-10 [65841073410]

PRAMIPEXOLE DIHYDROCHLORIDE TABLET

• Marketing Category: ANDA
• Application Number: ANDA078920
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2010-07-10

NDC 65841-734-16 [65841073416]

PRAMIPEXOLE DIHYDROCHLORIDE TABLET

• Marketing Category: ANDA
• Application Number: ANDA078920
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2010-07-10

Drug Details

Active Ingredients

Ingredient	Strength
PRAMIPEXOLE DIHYDROCHLORIDE	.125 mg/1

OpenFDA Data

• SPL SET ID: 0ac104bc-8ee9-4602-b1b3-38521342f97c
• Manufacturer:
  • Cadila Healthcare Limited
• UNII:
  • 3D867NP06J
• RxNorm Concept Unique ID - RxCUI:
  • 859040
  • 859048
  • 859033
  • 859044
  • 859052
• UPC Code:
  • 0365841734102
  • 0365841736106
  • 0365841737103
  • 0365841735109

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