guanfacine

Generic: guanfacine

Labeler: fosun pharma usa, inc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name guanfacine
Generic Name guanfacine
Labeler fosun pharma usa, inc
Dosage Form TABLET, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

guanfacine hydrochloride 4 mg/1

Manufacturer
Fosun Pharma USA, Inc

Identifiers & Regulatory

Product NDC 72266-258
Product ID 72266-258_261bff95-e6fc-3353-e063-6394a90ad699
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA217638
Listing Expiration 2026-12-31
Marketing Start 2025-06-28

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 72266258
Hyphenated Format 72266-258

Supplemental Identifiers

RxCUI
862006 862013 862019 862025
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 guanfacine (source: ndc)
Generic Name guanfacine (source: ndc)
Application Number ANDA217638 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 4 mg/1
source: ndc
Packaging
  • 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (72266-258-55)
source: ndc

Packages (1)

72266-258-55 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (72266-258-55)

Ingredients (1)

guanfacine hydrochloride (4 mg/1)

Linked Drug Pages (1)

Guanfacine ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "261bff95-e6fc-3353-e063-6394a90ad699", "openfda": {"unii": ["PML56A160O"], "rxcui": ["862006", "862013", "862019", "862025"], "spl_set_id": ["261c06ce-8708-d659-e063-6294a90ac381"], "manufacturer_name": ["Fosun Pharma USA, Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, EXTENDED RELEASE in 1 BOTTLE (72266-258-55)", "package_ndc": "72266-258-55", "marketing_start_date": "20250628"}], "brand_name": "Guanfacine", "product_id": "72266-258_261bff95-e6fc-3353-e063-6394a90ad699", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Adrenergic alpha2-Agonists [MoA]", "Central alpha-2 Adrenergic Agonist [EPC]"], "product_ndc": "72266-258", "generic_name": "guanfacine", "labeler_name": "Fosun Pharma USA, Inc", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Guanfacine", "active_ingredients": [{"name": "GUANFACINE HYDROCHLORIDE", "strength": "4 mg/1"}], "application_number": "ANDA217638", "marketing_category": "ANDA", "marketing_start_date": "20250628", "listing_expiration_date": "20261231"}