NDC 64725-0513

Intuniv

Guanfacine

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

• Product ID: 64725-0513_6d3d53d5-10d9-46a7-a251-f1eb1a2ffeeb
• NDC: 64725-0513
• 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: TYA Pharmaceuticals
• Substance Name: GUANFACINE HYDROCHLORIDE
• Active Ingredient Strength: 1 mg/1
• Pharm Classes: Central alpha-2 Adrenergic Agonist [EPC],Adrenergic alpha2-Agonists [MoA]
• NDC Exclude Flag: E
• Listing Certified Through: 2017-12-31

Packaging

NDC 64725-0513-1

100 TABLET, EXTENDED RELEASE in 1 BOTTLE (64725-0513-1)

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

NDC SPL Data Element Entries

NDC 64725-0513-1 [64725051301]

Intuniv TABLET, EXTENDED RELEASE

• Marketing Category: NDA
• Application Number: NDA022037
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2009-09-02
• Inactivation Date: 2020-01-31

Drug Details

Active Ingredients

Ingredient	Strength
GUANFACINE HYDROCHLORIDE	1 mg/1

OpenFDA Data

• SPL SET ID: 1bb3fac5-11e8-4d1c-a5e4-2520abcdeb47
• Manufacturer:
  • TYA Pharmaceuticals
• UNII:
  • PML56A160O
• RxNorm Concept Unique ID - RxCUI:
  • 862006
  • 862015
  • 862010
  • 862013

Pharmacological Class

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

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