NDC 33342-208

Pramipexole Dihydrochloride

Pramipexole Dihydrochloride

Pramipexole Dihydrochloride is a Oral Tablet, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Macleods Pharmaceuticals Limited. The primary component is Pramipexole Dihydrochloride.

• Product ID: 33342-208_2093e34c-e526-435f-b884-6ac9e05e1d99
• NDC: 33342-208
• Product Type: Human Prescription Drug
• Proprietary Name: Pramipexole Dihydrochloride
• Generic Name: Pramipexole Dihydrochloride
• Dosage Form: Tablet, Extended Release
• Route of Administration: ORAL
• Marketing Start Date: 2017-01-01
• Marketing Category: ANDA / ANDA
• Application Number: ANDA206156
• Labeler Name: Macleods Pharmaceuticals 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: 2020-12-31

Packaging

NDC 33342-208-07

30 TABLET, EXTENDED RELEASE in 1 BOTTLE (33342-208-07)

• Marketing Start Date: 2020-08-24
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 33342-208-12 [33342020812]

Pramipexole Dihydrochloride TABLET, EXTENDED RELEASE

• Marketing Category: ANDA
• Application Number: ANDA206156
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2017-01-01

NDC 33342-208-07 [33342020807]

Pramipexole Dihydrochloride TABLET, EXTENDED RELEASE

• Marketing Category: ANDA
• Application Number: ANDA206156
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2017-01-01

Drug Details

Active Ingredients

Ingredient	Strength
PRAMIPEXOLE DIHYDROCHLORIDE	.375 mg/1

OpenFDA Data

• SPL SET ID: 1dbb8d2f-e0d9-4f8b-89d2-2a03496ef7be
• Manufacturer:
  • Macleods Pharmaceuticals Limited
• UNII:
  • 3D867NP06J
• RxNorm Concept Unique ID - RxCUI:
  • 901534
  • 901550
  • 901555
  • 901546
  • 1114485
  • 901541
  • 1114479
• UPC Code:
  • 0333342214072
  • 0333342208071
  • 0333342211071
  • 0333342210074
  • 0333342212078
  • 0333342209078

Pharmacological Class

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

Medicade Reported Pricing

33342020807 PRAMIPEXOLE ER 0.375 MG TABLET

Pricing Unit: EA | Drug Type:

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