NDC 0597-0116

Mirapex ER

Pramipexole Dihydrochloride

Mirapex ER is a Oral Tablet, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Boehringer Ingelheim Pharmaceuticals, Inc.. The primary component is Pramipexole Dihydrochloride.

• Product ID: 0597-0116_52132628-35e3-4594-a642-da7162158112
• NDC: 0597-0116
• Product Type: Human Prescription Drug
• Proprietary Name: Mirapex ER
• Generic Name: Pramipexole Dihydrochloride
• Dosage Form: Tablet, Extended Release
• Route of Administration: ORAL
• Marketing Start Date: 2010-02-22
• Marketing Category: NDA / NDA
• Application Number: NDA022421
• Labeler Name: Boehringer Ingelheim Pharmaceuticals, 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: 2023-12-31

Packaging

NDC 0597-0116-30

1 BOTTLE, PLASTIC in 1 CARTON (0597-0116-30) > 30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC

• Marketing Start Date: 2010-02-22
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0597-0116-30 [00597011630]

Mirapex ER TABLET, EXTENDED RELEASE

• Marketing Category: NDA
• Application Number: NDA022421
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2010-02-22

Drug Details

Active Ingredients

Ingredient	Strength
PRAMIPEXOLE DIHYDROCHLORIDE	4.5 mg/1

OpenFDA Data

• SPL SET ID: e2902ed1-cfeb-4815-adc3-129c577917a1
• Manufacturer:
  • Boehringer Ingelheim Pharmaceuticals, Inc.
• UNII:
  • 3D867NP06J
• RxNorm Concept Unique ID - RxCUI:
  • 901534
  • 1114481
  • 901550
  • 901551
  • 901555
  • 901557
  • 901547
  • 901546
  • 901543
  • 901537
  • 901541
  • 1114487
  • 1114479
  • 1114485

Pharmacological Class

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

NDC Crossover Matching brand name "Mirapex ER" or generic name "Pramipexole Dihydrochloride"

NDC	Brand Name	Generic Name
0597-0287	Mirapex ER	Mirapex ER
0597-0286	Mirapex ER	Mirapex ER
0597-0101	Mirapex	pramipexole dihydrochloride
0597-0109	Mirapex	pramipexole dihydrochloride
0597-0113	Mirapex	pramipexole dihydrochloride
0597-0115	Mirapex	pramipexole dihydrochloride
0597-0116	Mirapex	pramipexole dihydrochloride
0597-0183	Mirapex	pramipexole dihydrochloride
0597-0184	Mirapex	pramipexole dihydrochloride
0597-0185	Mirapex	pramipexole dihydrochloride
0597-0190	Mirapex	pramipexole dihydrochloride
0597-0191	Mirapex	pramipexole dihydrochloride
0597-0285	Mirapex	pramipexole dihydrochloride