guanfacine

Generic: guanfacine

Labeler: actavis pharma, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

guanfacine hydrochloride 1 mg/1

Manufacturer
Actavis Pharma, Inc.

Identifiers & Regulatory

Product NDC 0228-2850
Product ID 0228-2850_b9040df2-42e8-404d-9b90-331dd3efc38c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA200881
Listing Expiration 2026-12-31
Marketing Start 2014-12-01

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 02282850
Hyphenated Format 0228-2850

Supplemental Identifiers

RxCUI
862006 862013 862019 862025
UPC
0302282853115 0302282851111 0302282850114
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 ANDA200881 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 1 mg/1
source: ndc
Packaging
  • 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (0228-2850-11)
source: ndc

Packages (1)

0228-2850-11 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (0228-2850-11)

Ingredients (1)

guanfacine hydrochloride (1 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": "b9040df2-42e8-404d-9b90-331dd3efc38c", "openfda": {"upc": ["0302282853115", "0302282851111", "0302282850114"], "unii": ["PML56A160O"], "rxcui": ["862006", "862013", "862019", "862025"], "spl_set_id": ["3a171942-37af-430d-8b9d-bb678ca2be4b"], "manufacturer_name": ["Actavis Pharma, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, EXTENDED RELEASE in 1 BOTTLE (0228-2850-11)", "package_ndc": "0228-2850-11", "marketing_start_date": "20141201"}], "brand_name": "guanfacine", "product_id": "0228-2850_b9040df2-42e8-404d-9b90-331dd3efc38c", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Adrenergic alpha2-Agonists [MoA]", "Central alpha-2 Adrenergic Agonist [EPC]"], "product_ndc": "0228-2850", "generic_name": "guanfacine", "labeler_name": "Actavis Pharma, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "guanfacine", "active_ingredients": [{"name": "GUANFACINE HYDROCHLORIDE", "strength": "1 mg/1"}], "application_number": "ANDA200881", "marketing_category": "ANDA", "marketing_start_date": "20141201", "listing_expiration_date": "20261231"}