0378-4094 : Ropinirole 12 mg 24 Hr Extended Release Tablet


NDC: 0378-4094
Labeler: Mylan Pharmaceuticals Inc.
Product Type: Human Prescription Drug
Drug Name:  Ropinirole Hydrochloride
Dosage Form: Oral Tablet, Film Coated, Extended Release
Application #: ANDA200462
Rev. Date: 


Appearance:


Markings: M;RE12
Shapes:  Round
Colors:  Green
Size (mm): 10
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.

M RE12: (0378-4094) Ropinirole 12 mg 24 Hr Extended Release Tablet by Mylan 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:

  • 0378-4094-05: 500 TABLET, FILM COATED, EXTENDED RELEASE IN 1 BOTTLE, PLASTIC (0378‑4094‑05)
  • 0378-4094-77: 90 TABLET, FILM COATED, EXTENDED RELEASE IN 1 BOTTLE, PLASTIC (0378‑4094‑77)
  • 0378-4094-93: 30 TABLET, FILM COATED, EXTENDED RELEASE IN 1 BOTTLE, PLASTIC (0378‑4094‑93)

Active Ingredients:

  • Ropinirole Hydrochloride

Dosage Strength:

  • 12 mg

Inactive Ingredients:

  • Anhydrous Lactose
  • Ferrosoferric Oxide
  • Silicon Dioxide
  • Ethylcelluloses
  • Fd&c Red No. 40
  • Fd&c Yellow No. 6
  • Hypromelloses
  • Magnesium Stearate
  • Cellulose, Microcrystalline
  • Propylene Glycol
  • Fd&c Blue No. 2
  • D&c Yellow No. 10

Pharmaceutical Classes:

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

Related Products:

Based on records with the same trade name.
  • 0378-4090 Ropinirole 2 mg 24 Hr Extended Release Tablet by Mylan Pharmaceuticals Inc.
  • 0378-4091 Ropinirole 4 mg 24 Hr Extended Release Tablet by Mylan Pharmaceuticals Inc.
  • 0378-4092 Ropinirole 6 mg 24 Hr Extended Release Tablet by Mylan Pharmaceuticals Inc.
  • 0378-4093 Ropinirole 8 mg 24 Hr Extended Release Tablet by Mylan Pharmaceuticals Inc.
  • 0378-4095 Ropinirole 3 mg 24 Hr Extended Release Tablet by Mylan Pharmaceuticals Inc.
  • 0378-5501 Ropinirole 1 mg (As Ropinirole Hydrochloride) Oral Tablet by Mylan Pharmaceuticals Inc.
  • 0378-5502 Ropinirole 2 mg (As Ropinirole Hydrochloride) Oral Tablet by Mylan Pharmaceuticals Inc.
  • 0378-5503 Ropinirole 3 mg (As Ropinirole Hydrochloride) Oral Tablet by Mylan Pharmaceuticals Inc.
  • 0378-5504 Ropinirole 4 mg (As Ropinirole Hydrochloride) Oral Tablet by Mylan Pharmaceuticals Inc.
  • 0378-5505 Ropinirole (As Ropinirole Hydrochloride) 5 mg Oral Tablet by Mylan Pharmaceuticals Inc.
  • 0378-5525 Ropinirole 0.25 mg (As Ropinirole Hydrochloride) Oral Tablet by Mylan Pharmaceuticals Inc.
  • 0378-5550 Ropinirole (As Ropinirole Hydrochloride) 0.5 mg Oral Tablet by Mylan Pharmaceuticals Inc.
  • 0093-5285 Ropinirole 2 mg (As Ropinirole Hydrochloride) Oral Tablet by Teva Pharmaceuticals USA Inc
  • 0093-5286 Ropinirole 3 mg (As Ropinirole Hydrochloride) Oral Tablet by Teva Pharmaceuticals USA Inc
  • 0093-5287 Ropinirole 4 mg (As Ropinirole Hydrochloride) Oral Tablet by Teva Pharmaceuticals USA Inc
  • 0093-5288 Ropinirole (As Ropinirole Hydrochloride) 5 mg Oral Tablet by Teva Pharmaceuticals USA Inc
  • 0591-3611 Ropinirole 2 mg 24 Hr Extended Release Tablet by Watson Laboratories, Inc.
  • 0591-3612 Ropinirole 12 mg 24 Hr Extended Release Tablet by Watson Laboratories, Inc.
  • 0591-3613 Ropinirole 4 mg 24 Hr Extended Release Tablet by Watson Laboratories, Inc.
  • 0591-3614 Ropinirole 8 mg 24 Hr Extended Release Tablet by Watson Laboratories, Inc.
  • More related products ...

NDC QR Code

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NDC 0378-4094 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.