NDC 10370-253

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 Par Pharmaceutical, Inc.. The primary component is Pramipexole Dihydrochloride.

• Product ID: 10370-253_2b6f1e16-0d57-41c5-adf8-45a3fdb21670
• NDC: 10370-253
• 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: 2015-02-09
• Marketing Category: ANDA / ANDA
• Application Number: ANDA202206
• Labeler Name: Par Pharmaceutical, Inc.
• Substance Name: PRAMIPEXOLE DIHYDROCHLORIDE
• Active Ingredient Strength: 2 mg/1
• Pharm Classes: Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 10370-253-11

30 TABLET, EXTENDED RELEASE in 1 BOTTLE (10370-253-11)

• Marketing Start Date: 2015-02-09
• Marketing End Date: 2023-09-30
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 10370-253-11 [10370025311]

Pramipexole Dihydrochloride Extended-Release TABLET, EXTENDED RELEASE

• Marketing Category: ANDA
• Application Number: ANDA202206
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2015-02-09

Drug Details

Active Ingredients

Ingredient	Strength
PRAMIPEXOLE DIHYDROCHLORIDE	1.5 mg/1

OpenFDA Data

• SPL SET ID: 79d73ae4-beaf-4a99-b0f3-d66438c122bd
• Manufacturer:
  • Par Pharmaceutical, Inc.
• UNII:
  • 3D867NP06J
• RxNorm Concept Unique ID - RxCUI:
  • 901534
  • 901550
  • 901555
  • 901546
  • 1114485
  • 901541
  • 1114479

Pharmacological Class

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

Medicade Reported Pricing

10370025311 PRAMIPEXOLE ER 1.5 MG TABLET

Pricing Unit: EA | Drug Type:

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