guanfacine

Generic: guanfacine

Labeler: a-s medication solutions
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name guanfacine
Generic Name guanfacine
Labeler a-s medication solutions
Dosage Form TABLET, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

guanfacine hydrochloride 3 mg/1

Manufacturer
A-S Medication Solutions

Identifiers & Regulatory

Product NDC 50090-7644
Product ID 50090-7644_0db3ff09-e75b-4a2b-a0bf-1a9459b917a4
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA217269
Listing Expiration 2026-12-31
Marketing Start 2023-08-08

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 500907644
Hyphenated Format 50090-7644

Supplemental Identifiers

RxCUI
862019
UNII
PML56A160O

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 ANDA217269 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 3 mg/1
source: ndc
Packaging
  • 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (50090-7644-0)
source: ndc

Packages (1)

50090-7644-0 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (50090-7644-0)

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": "0db3ff09-e75b-4a2b-a0bf-1a9459b917a4", "openfda": {"unii": ["PML56A160O"], "rxcui": ["862019"], "spl_set_id": ["0836a1d5-f1fc-4b94-9667-667278a74c93"], "manufacturer_name": ["A-S Medication Solutions"]}, "finished": true, "packaging": [{"sample": false, "description": "90 TABLET, EXTENDED RELEASE in 1 BOTTLE (50090-7644-0)", "package_ndc": "50090-7644-0", "marketing_start_date": "20250828"}], "brand_name": "GUANFACINE", "product_id": "50090-7644_0db3ff09-e75b-4a2b-a0bf-1a9459b917a4", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Adrenergic alpha2-Agonists [MoA]", "Central alpha-2 Adrenergic Agonist [EPC]"], "product_ndc": "50090-7644", "generic_name": "GUANFACINE", "labeler_name": "A-S Medication Solutions", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "GUANFACINE", "active_ingredients": [{"name": "GUANFACINE HYDROCHLORIDE", "strength": "3 mg/1"}], "application_number": "ANDA217269", "marketing_category": "ANDA", "marketing_start_date": "20230808", "listing_expiration_date": "20261231"}