intuniv

Generic: guanfacine

Labeler: takeda pharmaceuticals america, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name intuniv
Generic Name guanfacine
Labeler takeda pharmaceuticals america, inc.
Dosage Form TABLET, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

guanfacine hydrochloride 2 mg/1

Manufacturer
Takeda Pharmaceuticals America, Inc.

Identifiers & Regulatory

Product NDC 54092-515
Product ID 54092-515_448b4d80-7441-4a2f-839f-c61052d6e83a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA022037
Listing Expiration 2026-12-31
Marketing Start 2009-09-02

Pharmacologic Class

Classes
adrenergic alpha2-agonists [moa] central alpha-2 adrenergic agonist [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 54092515
Hyphenated Format 54092-515

Supplemental Identifiers

RxCUI
862006 862010 862013 862015 862019 862021 862025 862027 1092566 1092567
UPC
0354092513024 0354092519026 0354092515028 0354092517022
UNII
PML56A160O

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name intuniv (source: ndc)
Generic Name guanfacine (source: ndc)
Application Number NDA022037 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 2 mg/1
source: ndc
Packaging
  • 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (54092-515-02)
source: ndc

Packages (1)

54092-515-02 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (54092-515-02)

Ingredients (1)

guanfacine hydrochloride (2 mg/1)

Linked Drug Pages (1)

Intuniv ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "448b4d80-7441-4a2f-839f-c61052d6e83a", "openfda": {"upc": ["0354092513024", "0354092519026", "0354092515028", "0354092517022"], "unii": ["PML56A160O"], "rxcui": ["862006", "862010", "862013", "862015", "862019", "862021", "862025", "862027", "1092566", "1092567"], "spl_set_id": ["b972af81-3a37-40be-9fe1-3ddf59852528"], "manufacturer_name": ["Takeda Pharmaceuticals America, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, EXTENDED RELEASE in 1 BOTTLE (54092-515-02)", "package_ndc": "54092-515-02", "marketing_start_date": "20090902"}], "brand_name": "Intuniv", "product_id": "54092-515_448b4d80-7441-4a2f-839f-c61052d6e83a", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Adrenergic alpha2-Agonists [MoA]", "Central alpha-2 Adrenergic Agonist [EPC]"], "product_ndc": "54092-515", "generic_name": "guanfacine", "labeler_name": "Takeda Pharmaceuticals America, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Intuniv", "active_ingredients": [{"name": "GUANFACINE HYDROCHLORIDE", "strength": "2 mg/1"}], "application_number": "NDA022037", "marketing_category": "NDA", "marketing_start_date": "20090902", "listing_expiration_date": "20261231"}