NDC 54092-513

Intuniv

Guanfacine

Intuniv is a Oral Tablet, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Takeda Pharmaceuticals America, Inc.. The primary component is Guanfacine Hydrochloride.

• Product ID: 54092-513_1eef54c1-5c87-44f1-bab6-42f72d4fe0be
• NDC: 54092-513
• Product Type: Human Prescription Drug
• Proprietary Name: Intuniv
• Generic Name: Guanfacine
• Dosage Form: Tablet, Extended Release
• Route of Administration: ORAL
• Marketing Start Date: 2009-09-02
• Marketing Category: NDA / NDA
• Application Number: NDA022037
• Labeler Name: Takeda Pharmaceuticals America, Inc.
• Substance Name: GUANFACINE HYDROCHLORIDE
• Active Ingredient Strength: 1 mg/1
• Pharm Classes: Adrenergic alpha2-Agonists [MoA], Central alpha-2 Adrenergic Agonist [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2023-12-31

Packaging

NDC 54092-513-02

100 TABLET, EXTENDED RELEASE in 1 BOTTLE (54092-513-02)

• Marketing Start Date: 2009-09-02
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 54092-513-02 [54092051302]

Intuniv TABLET, EXTENDED RELEASE

• Marketing Category: NDA
• Application Number: NDA022037
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2009-09-02

NDC 54092-513-03 [54092051303]

Intuniv TABLET, EXTENDED RELEASE

• Marketing Category: NDA
• Application Number: NDA022037
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2009-09-02

Drug Details

Active Ingredients

Ingredient	Strength
GUANFACINE HYDROCHLORIDE	1 mg/1

OpenFDA Data

• SPL SET ID: b972af81-3a37-40be-9fe1-3ddf59852528
• Manufacturer:
  • Shire US Manufacturing Inc.
• UNII:
  • PML56A160O
• RxNorm Concept Unique ID - RxCUI:
  • 862019
  • 862006
  • 862021
  • 862010
  • 862013
  • 862025
  • 862015
  • 862027
  • 1092566
  • 1092567
• UPC Code:
  • 0354092513024
  • 0354092519026
  • 0354092515028

Pharmacological Class

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

Medicade Reported Pricing

54092051302 INTUNIV ER 1 MG TABLET

Pricing Unit: EA | Drug Type:

NDC Crossover Matching brand name "Intuniv" or generic name "Guanfacine"

NDC	Brand Name	Generic Name
54092-520	Intuniv	Intuniv
54092-513	Intuniv	Intuniv
54092-517	Intuniv	Intuniv
54092-515	Intuniv	Intuniv
54092-519	Intuniv	Intuniv
64725-0513	Intuniv	Intuniv
64725-0515	Intuniv	Intuniv
0093-5960	Guanfacine	Guanfacine
0093-5961	Guanfacine	Guanfacine
0093-5963	Guanfacine	Guanfacine
0093-5964	Guanfacine	Guanfacine
0228-2850	guanfacine	guanfacine
0228-2851	guanfacine	guanfacine
0228-2853	guanfacine	guanfacine
0228-2855	guanfacine	guanfacine