guanfacine extended-release

Generic: guanfacine

Labeler: apotex corp.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name guanfacine extended-release
Generic Name guanfacine
Labeler apotex corp.
Dosage Form TABLET, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

guanfacine hydrochloride 3 mg/1

Manufacturer
Apotex Corp.

Identifiers & Regulatory

Product NDC 60505-3929
Product ID 60505-3929_00fff10c-71af-e1a3-235f-51b131ccc17d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA205430
Listing Expiration 2026-12-31
Marketing Start 2018-10-03

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 605053929
Hyphenated Format 60505-3929

Supplemental Identifiers

RxCUI
862006 862013 862019 862025
UPC
0360505392711 0360505392810 0360505393015 0360505392919
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 extended-release (source: ndc)
Generic Name guanfacine (source: ndc)
Application Number ANDA205430 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 3 mg/1
source: ndc
Packaging
  • 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (60505-3929-1)
source: ndc

Packages (1)

60505-3929-1 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (60505-3929-1)

Ingredients (1)

guanfacine hydrochloride (3 mg/1)

Linked Drug Pages (1)

Guanfacine extended-release ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "00fff10c-71af-e1a3-235f-51b131ccc17d", "openfda": {"upc": ["0360505392711", "0360505392810", "0360505393015", "0360505392919"], "unii": ["PML56A160O"], "rxcui": ["862006", "862013", "862019", "862025"], "spl_set_id": ["1c492e87-3406-ddb8-aaf2-e609c2ded503"], "manufacturer_name": ["Apotex Corp."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, EXTENDED RELEASE in 1 BOTTLE (60505-3929-1)", "package_ndc": "60505-3929-1", "marketing_start_date": "20181003"}], "brand_name": "Guanfacine extended-release", "product_id": "60505-3929_00fff10c-71af-e1a3-235f-51b131ccc17d", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Adrenergic alpha2-Agonists [MoA]", "Central alpha-2 Adrenergic Agonist [EPC]"], "product_ndc": "60505-3929", "generic_name": "guanfacine", "labeler_name": "Apotex Corp.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Guanfacine extended-release", "active_ingredients": [{"name": "GUANFACINE HYDROCHLORIDE", "strength": "3 mg/1"}], "application_number": "ANDA205430", "marketing_category": "ANDA", "marketing_start_date": "20181003", "listing_expiration_date": "20261231"}