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
Routes
ORAL
Active Ingredients

guanfacine hydrochloride 1 mg/1

Manufacturer
Actavis Pharma, Inc.

Identifiers & Regulatory

Product NDC 0591-0444
Product ID 0591-0444_3ed0b0fa-4fd2-494b-ba55-52fcf77bc9d6
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA074145
Listing Expiration 2026-12-31
Marketing Start 1995-10-17

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 05910444
Hyphenated Format 0591-0444

Supplemental Identifiers

RxCUI
197745 197746
UPC
0305910453015 0305910444013
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 ANDA074145 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 1 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE, PLASTIC (0591-0444-01)
source: ndc

Packages (1)

0591-0444-01 100 TABLET in 1 BOTTLE, PLASTIC (0591-0444-01)

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": "3ed0b0fa-4fd2-494b-ba55-52fcf77bc9d6", "openfda": {"upc": ["0305910453015", "0305910444013"], "unii": ["PML56A160O"], "rxcui": ["197745", "197746"], "spl_set_id": ["a81b956b-f004-4426-ba20-375ccf21eb71"], "manufacturer_name": ["Actavis Pharma, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE, PLASTIC (0591-0444-01)", "package_ndc": "0591-0444-01", "marketing_start_date": "19951017"}], "brand_name": "Guanfacine", "product_id": "0591-0444_3ed0b0fa-4fd2-494b-ba55-52fcf77bc9d6", "dosage_form": "TABLET", "pharm_class": ["Adrenergic alpha2-Agonists [MoA]", "Central alpha-2 Adrenergic Agonist [EPC]"], "product_ndc": "0591-0444", "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": "ANDA074145", "marketing_category": "ANDA", "marketing_start_date": "19951017", "listing_expiration_date": "20261231"}