0597-0116 : 24 Hr Mirapex 4.5 mg Extended Release Tablet


NDC: 0597-0116
Labeler: Boehringer Ingelheim Pharmaceuticals, Inc.
Product Type: Human Prescription Drug
Drug Name:  Mirapex ER
Dosage Form: Oral Tablet, Extended Release
Application #: NDA022421
Rev. Date: 


Appearance:


Markings: ER;4;5
Shapes:  Oval
Colors:  White
Size (mm): 16
Segments: * 1

* Segments = the number of equally sized pieces which the pill can be broken into. In this case, a value of 1 indicates a solid pill with no score lines.

ER 4 5: (0597-0116) 24 Hr Mirapex 4.5 mg Extended Release Tablet by Boehringer Ingelheim Pharmaceuticals, Inc.
The above image is provided by the U.S. National Library of Medicine (NLM) and is not part of the official label.

NDC Package Codes:

  • 0597-0116-30: 1 BOTTLE, PLASTIC IN 1 CARTON (0597‑0116‑30) > 30 TABLET, EXTENDED RELEASE IN 1 BOTTLE, PLASTIC

Active Ingredients:

  • Pramipexole Dihydrochloride

Dosage Strength:

  • 4.5 mg

Pharmaceutical Classes:

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

Related Products:

Based on records with the same trade name.
  • 0597-0101 Mirapex 0.75 mg Oral Tablet by Boehringer Ingelheim Pharmaceuticals, Inc.
  • 0597-0109 24 Hr Mirapex 0.375 mg Extended Release Tablet by Boehringer Ingelheim Pharmaceuticals, Inc.
  • 0597-0113 24 Hr Mirapex 1.5 mg Extended Release Tablet by Boehringer Ingelheim Pharmaceuticals, Inc.
  • 0597-0115 24 Hr Mirapex 3 mg Extended Release Tablet by Boehringer Ingelheim Pharmaceuticals, Inc.
  • 0597-0183 Mirapex 0.125 mg Oral Tablet by Boehringer Ingelheim Pharmaceuticals, Inc.
  • 0597-0184 Mirapex 0.25 mg Oral Tablet by Boehringer Ingelheim Pharmaceuticals, Inc.
  • 0597-0185 Mirapex 0.5 mg Oral Tablet by Boehringer Ingelheim Pharmaceuticals, Inc.
  • 0597-0190 Mirapex 1 mg Oral Tablet by Boehringer Ingelheim Pharmaceuticals, Inc.
  • 0597-0191 Mirapex 1.5 mg Oral Tablet by Boehringer Ingelheim Pharmaceuticals, Inc.
  • 0597-0285 24 Hr Mirapex 0.75 mg Extended Release Tablet by Boehringer Ingelheim Pharmaceuticals, Inc.
  • 0597-0286 24 Hr Mirapex 2.25 mg Extended Release Tablet by Boehringer Ingelheim Pharmaceuticals, Inc.
  • 0597-0287 24 Hr Mirapex 3.75 mg Extended Release Tablet by Boehringer Ingelheim Pharmaceuticals, Inc.
  • 21695-867 Mirapex 0.5 mg Oral Tablet by Rebel Distributors Corp
  • 35356-392 Mirapex 0.125 mg Oral Tablet by Lake Erie Medical Dba Quality Care Products LLC
  • 54868-4211 Mirapex 0.25 mg Oral Tablet by Physicians Total Care, Inc.
  • 54868-4912 Mirapex 0.125 mg Oral Tablet by Physicians Total Care, Inc.
  • 54868-5412 Mirapex 0.5 mg Oral Tablet by Physicians Total Care, Inc.
  • 54868-5746 Mirapex 1 mg Oral Tablet by Physicians Total Care, Inc.
  • 55154-0409 Mirapex 0.25 mg Oral Tablet by Cardinal Health

NDC QR Code

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NDC 0597-0116 QR Code

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Note: The RxChat NDC Database uses publicly available data from the FDA and the U.S. National Library of Medicine (NLM); The NLM is not responsible for the data presented and does not endorse or recommend this or any other product. While we make every effort to ensure that the information presented is accurate, you should assume that all results are unvalidated. To report any errors or inconsistencies please contact us.