NDC 42291-557

Pramipexole Dihydrochloride Extended-Release

Pramipexole

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

• Product ID: 42291-557_7e17404b-77ac-1a76-e053-2991aa0a82c9
• NDC: 42291-557
• Product Type: Human Prescription Drug
• Proprietary Name: Pramipexole Dihydrochloride Extended-Release
• Generic Name: Pramipexole
• Dosage Form: Tablet, Extended Release
• Route of Administration: ORAL
• Marketing Start Date: 2016-07-05
• Marketing Category: ANDA / ANDA
• Application Number: ANDA202206
• Labeler Name: AvKARE, Inc.
• Substance Name: PRAMIPEXOLE DIHYDROCHLORIDE
• Active Ingredient Strength: 5 mg/1
• Pharm Classes: Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 42291-557-90

90 TABLET, EXTENDED RELEASE in 1 BOTTLE (42291-557-90)

• Marketing Start Date: 2016-11-23
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 42291-557-90 [42291055790]

Pramipexole Dihydrochloride Extended-Release TABLET, EXTENDED RELEASE

• Marketing Category: ANDA
• Application Number: ANDA202206
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2016-11-23
• Marketing End Date: 2019-04-30

Drug Details

Active Ingredients

Ingredient	Strength
PRAMIPEXOLE DIHYDROCHLORIDE	4.5 mg/1

OpenFDA Data

• SPL SET ID: fd5fea0e-231e-a5bf-98b7-f7e95b765c7a
• Manufacturer:
  • AvKARE, Inc.
• UNII:
  • 3D867NP06J
• RxNorm Concept Unique ID - RxCUI:
  • 901550
  • 901546
  • 901555
  • 901534

Pharmacological Class

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

NDC Crossover Matching brand name "Pramipexole Dihydrochloride Extended-Release" or generic name "Pramipexole"

NDC	Brand Name	Generic Name
31722-906	PRAMIPEXOLE	PRAMIPEXOLE
31722-907	PRAMIPEXOLE	PRAMIPEXOLE
31722-908	PRAMIPEXOLE	PRAMIPEXOLE
31722-909	PRAMIPEXOLE	PRAMIPEXOLE
31722-910	PRAMIPEXOLE	PRAMIPEXOLE
31722-911	PRAMIPEXOLE	PRAMIPEXOLE
50090-3009	PRAMIPEXOLE	PRAMIPEXOLE
10370-251	Pramipexole Dihydrochloride	Pramipexole
10370-252	Pramipexole Dihydrochloride	Pramipexole
10370-253	Pramipexole Dihydrochloride	Pramipexole
10370-254	Pramipexole Dihydrochloride	Pramipexole
10370-255	Pramipexole Dihydrochloride	Pramipexole
10370-305	Pramipexole Dihydrochloride	Pramipexole
10370-306	Pramipexole Dihydrochloride	Pramipexole
42291-557	Pramipexole Dihydrochloride	Pramipexole