42291-555 : Pramipexole Dihydrochloride Extended-release 1.5 mg Oral Tablet, Extended Release


NDC: 42291-555
Labeler: Avkare, Inc.
Product Type: Human Prescription Drug
Drug Name:  Pramipexole Dihydrochloride Extended-release
Dosage Form: Oral Tablet, Extended Release
Application #: ANDA202206
Rev. Date: 


Appearance:


Markings: 253
Shapes:  Oval
Colors:  White
Size (mm): 14
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.

NDC Package Codes:

  • 42291-555-90: 90 TABLET, EXTENDED RELEASE IN 1 BOTTLE (42291‑555‑90)

Active Ingredients:

  • Pramipexole Dihydrochloride

Dosage Strength:

  • 1.5 mg

Inactive Ingredients:

  • Hypromelloses
  • Starch, Corn
  • Silicon Dioxide
  • D&c Yellow No. 10
  • Hydrogenated Cottonseed Oil
  • Hydroxypropyl Cellulose (Type H)
  • Magnesium Stearate
  • Mannitol
  • Cellulose, Microcrystalline
  • Polyvinyl Alcohol (18000 Mw)
  • Titanium Dioxide
  • Talc
  • Lecithin, Soybean
  • Xanthan Gum

Pharmaceutical Classes:

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

Related Products:

Based on records with the same trade name.
  • 42291-554 Pramipexole Dihydrochloride Extended-release .75 mg Oral Tablet, Extended Release by Avkare, Inc.
  • 42291-556 Pramipexole Dihydrochloride Extended-release 3 mg Oral Tablet, Extended Release by Avkare, Inc.
  • 42291-557 Pramipexole Dihydrochloride Extended-release 4.5 mg Oral Tablet, Extended Release by Avkare, Inc.
  • 10370-251 Pramipexole Dihydrochloride .375 mg Oral Tablet, Extended Release by Par Pharmaceutical, Inc.
  • 10370-252 Pramipexole Dihydrochloride .75 mg Oral Tablet, Extended Release by Par Pharmaceutical, Inc.
  • 10370-253 Pramipexole Dihydrochloride 1.5 mg Oral Tablet, Extended Release by Par Pharmaceutical, Inc.
  • 10370-254 Pramipexole Dihydrochloride 3 mg Oral Tablet, Extended Release by Par Pharmaceutical, Inc.
  • 10370-255 Pramipexole Dihydrochloride Extended-release 4.5 mg Oral Tablet, Extended Release by Par Pharmaceutical
  • 10370-305 Pramipexole Dihydrochloride 2.25 mg Oral Tablet, Extended Release by Par Pharmaceutical, Inc.
  • 10370-306 Pramipexole Dihydrochloride Extended-release 3.75 mg Oral Tablet, Extended Release by Par Pharmaceutical
  • 69680-145 Pramipexole Dihydrochloride Extended-release .375 mg Oral Tablet, Extended Release by Vitruvias Therapeutics, Inc.
  • 71034-002 Pramipexole Dihydrochloride Extended-release .375 mg Oral Tablet, Extended Release by Xiamen Lp Pharmaceutical Co., Ltd.
  • 71034-003 Pramipexole Dihydrochloride Extended-release .75 mg Oral Tablet, Extended Release by Xiamen Lp Pharmaceutical Co., Ltd.

NDC QR Code

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NDC 42291-555 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.