guanfacine

Generic: guanfacine

Labeler: advagen pharma limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name guanfacine
Generic Name guanfacine
Labeler advagen pharma limited
Dosage Form TABLET, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

guanfacine hydrochloride 3 mg/1

Manufacturer
Advagen Pharma Limited

Identifiers & Regulatory

Product NDC 72888-226
Product ID 72888-226_3383419f-2181-88f4-e063-6394a90a38bc
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA219689
Listing Expiration 2026-12-31
Marketing Start 2025-04-15

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 72888226
Hyphenated Format 72888-226

Supplemental Identifiers

RxCUI
862006 862013 862019 862025
UPC
0372888202051 0372888227016 0372888225012 0372888224015 0372888226019
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 ANDA219689 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 3 mg/1
source: ndc
Packaging
  • 1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (72888-226-00)
  • 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (72888-226-01)
  • 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (72888-226-05)
  • 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (72888-226-30)
source: ndc

Packages (4)

72888-226-00 1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (72888-226-00) 72888-226-01 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (72888-226-01) 72888-226-05 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (72888-226-05) 72888-226-30 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (72888-226-30)

Ingredients (1)

guanfacine hydrochloride (3 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": "3383419f-2181-88f4-e063-6394a90a38bc", "openfda": {"upc": ["0372888202051", "0372888227016", "0372888225012", "0372888224015", "0372888226019"], "unii": ["PML56A160O"], "rxcui": ["862006", "862013", "862019", "862025"], "spl_set_id": ["e16beec7-9acd-4cd1-be5c-b666ad7d2430"], "manufacturer_name": ["Advagen Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (72888-226-00)", "package_ndc": "72888-226-00", "marketing_start_date": "20250415"}, {"sample": false, "description": "100 TABLET, EXTENDED RELEASE in 1 BOTTLE (72888-226-01)", "package_ndc": "72888-226-01", "marketing_start_date": "20250415"}, {"sample": false, "description": "500 TABLET, EXTENDED RELEASE in 1 BOTTLE (72888-226-05)", "package_ndc": "72888-226-05", "marketing_start_date": "20250415"}, {"sample": false, "description": "30 TABLET, EXTENDED RELEASE in 1 BOTTLE (72888-226-30)", "package_ndc": "72888-226-30", "marketing_start_date": "20250415"}], "brand_name": "GUANFACINE", "product_id": "72888-226_3383419f-2181-88f4-e063-6394a90a38bc", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Adrenergic alpha2-Agonists [MoA]", "Central alpha-2 Adrenergic Agonist [EPC]"], "product_ndc": "72888-226", "generic_name": "GUANFACINE", "labeler_name": "Advagen Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "GUANFACINE", "active_ingredients": [{"name": "GUANFACINE HYDROCHLORIDE", "strength": "3 mg/1"}], "application_number": "ANDA219689", "marketing_category": "ANDA", "marketing_start_date": "20250415", "listing_expiration_date": "20261231"}