13811-643 : Ropinirole 12 mg 24 Hr Extended Release Tablet


NDC: 13811-643
Labeler: Trigen Laboratories, Inc.
Product Type: Human Prescription Drug
Drug Name:  Ropinirole 12 mg
Dosage Form: Oral Tablet, Film Coated, Extended Release
Application #: ANDA202786
Rev. Date: 


Appearance:


Markings: L195
Shapes:  Capsule
Colors:  Green
Size (mm): 12
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:

  • 13811-643-01: 1000 TABLET, FILM COATED, EXTENDED RELEASE IN 1 BOTTLE (13811‑643‑01)
  • 13811-643-10: 100 TABLET, FILM COATED, EXTENDED RELEASE IN 1 BOTTLE (13811‑643‑10)
  • 13811-643-11: 100 TABLET, FILM COATED, EXTENDED RELEASE IN 1 CARTON (13811‑643‑11)
  • 13811-643-30: 30 TABLET, FILM COATED, EXTENDED RELEASE IN 1 BOTTLE (13811‑643‑30)
  • 13811-643-50: 500 TABLET, FILM COATED, EXTENDED RELEASE IN 1 BOTTLE (13811‑643‑50)
  • 13811-643-90: 90 TABLET, FILM COATED, EXTENDED RELEASE IN 1 BOTTLE (13811‑643‑90)

Active Ingredients:

  • Ropinirole Hydrochloride

Dosage Strength:

  • 12 mg

Inactive Ingredients:

  • Hypromelloses
  • Hydrogenated Castor Oil
  • Carboxymethylcellulose Sodium
  • Starch, Corn
  • Povidone K90
  • Silicon Dioxide
  • Magnesium Stearate
  • Ethylcelluloses
  • Titanium Dioxide
  • Polyethylene Glycol 6000
  • Ferric Oxide Yellow
  • Fd&c Blue No. 2

Pharmaceutical Classes:

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

Related Products:

Based on records with the same trade name.
  • 13811-639 Ropinirole 2 mg 24 Hr Extended Release Tablet by Trigen Laboratories, Inc.
  • 13811-640 Ropinirole 4 mg 24 Hr Extended Release Tablet by Trigen Laboratories, Inc.
  • 13811-641 Ropinirole 6 mg 24 Hr Extended Release Tablet by Trigen Laboratories, Inc.
  • 13811-642 Ropinirole 8 mg 24 Hr Extended Release Tablet by Trigen Laboratories, Inc.
  • 0054-0116 Ropinirole 0.25 mg (As Ropinirole Hydrochloride) Oral Tablet by Roxane Laboratories, Inc
  • 0054-0117 Ropinirole (As Ropinirole Hydrochloride) 0.5 mg Oral Tablet by Roxane Laboratories, Inc
  • 0054-0118 Ropinirole 1 mg (As Ropinirole Hydrochloride) Oral Tablet by Roxane Laboratories, Inc
  • 0054-0119 Ropinirole 2 mg (As Ropinirole Hydrochloride) Oral Tablet by Roxane Laboratories, Inc
  • 0054-0120 Ropinirole 3 mg (As Ropinirole Hydrochloride) Oral Tablet by Roxane Laboratories, Inc
  • 0054-0121 Ropinirole 4 mg (As Ropinirole Hydrochloride) Oral Tablet by Roxane Laboratories, Inc
  • 0054-0122 Ropinirole (As Ropinirole Hydrochloride) 5 mg Oral Tablet by Roxane Laboratories, Inc
  • 0228-3640 Ropinirole 6 mg 24 Hr Extended Release Tablet by Actavis Elizabeh LLC
  • 0228-3658 Ropinirole 2 mg 24 Hr Extended Release Tablet by Actavis Elizabeh LLC
  • 0228-3659 Ropinirole 4 mg 24 Hr Extended Release Tablet by Actavis Elizabeh LLC
  • 0228-3660 Ropinirole 8 mg 24 Hr Extended Release Tablet by Actavis Elizabeh LLC
  • 0228-3661 Ropinirole 12 mg 24 Hr Extended Release Tablet by Actavis Elizabeh LLC
  • 0781-5780 Ropinirole 2 mg 24 Hr Extended Release Tablet by Sandoz Inc
  • 0781-5782 Ropinirole 4 mg 24 Hr Extended Release Tablet by Sandoz Inc
  • 0781-5784 Ropinirole 6 mg 24 Hr Extended Release Tablet by Sandoz Inc
  • 0781-5786 Ropinirole 8 mg 24 Hr Extended Release Tablet by Sandoz Inc
  • More related products ...

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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.