54092-513 : Intuniv 1 mg 24 Hr Extended Release Tablet


NDC54092-513
Labeler: Shire Us Manufacturing Inc.
Product Type: Human Prescription Drug
Drug Name:  Intuniv
Dosage Form: Oral Tablet, Extended Release
Application #: NDA022037
Rev. Date: 


Appearance:


Markings: 503;1mg
Shapes:  Round
Colors:  White
Size (mm): 7
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.

503 1mg: (54092-513) Intuniv 1 mg 24 Hr Extended Release Tablet by Shire Us Manufacturing 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:

  • 54092-513-02: 100 TABLET, EXTENDED RELEASE IN 1 BOTTLE (54092‑513‑02)
  • 54092-513-03: 7 TABLET, EXTENDED RELEASE IN 1 BOTTLE (54092‑513‑03)

Active Ingredients:

  • Guanfacine Hydrochloride

Dosage Strength:

  • 1 mg

Inactive Ingredients:

  • Hypromellose 2208 (15000 Mpa.s)
  • Lactose Monohydrate
  • Povidones
  • Crospovidone
  • Methacrylic Acid - Methyl Methacrylate Copolymer (1:1)
  • Cellulose, Microcrystalline
  • Glyceryl Dibehenate
  • Fumaric Acid

Pharmaceutical Classes:

  • Adrenergic alpha2-Agonists [MoA]
  • Central alpha-2 Adrenergic Agonist [EPC]

Related Products:

Based on records with the same trade name.
  • 54092-515 Intuniv 2 mg 24 Hr Extended Release Tablet by Shire Us Manufacturing Inc.
  • 54092-517 Intuniv 3 mg 24 Hr Extended Release Tablet by Shire Us Manufacturing Inc.
  • 54092-519 Intuniv 4 mg 24 Hr Extended Release Tablet by Shire Us Manufacturing Inc.
  • 54092-520 Intuniv Kit 7/7 by Shire Us Manufacturing Inc.
  • 64725-0513 Intuniv 1 mg Oral Tablet, Extended Release by Tya Pharmaceuticals
  • 64725-0515 Intuniv 2 mg Oral Tablet, Extended Release by Tya Pharmaceuticals

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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.