guanfacine extended-release

Generic: guanfacine

Labeler: upsher-smith laboratories, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name guanfacine extended-release
Generic Name guanfacine
Labeler upsher-smith laboratories, llc
Dosage Form TABLET, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

guanfacine 4 mg/1

Manufacturer
Upsher-Smith Laboratories, LLC

Identifiers & Regulatory

Product NDC 24979-538
Product ID 24979-538_6634768f-1e5a-4604-9587-fe5ffbd7e331
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA201408
Listing Expiration 2026-12-31
Marketing Start 2017-07-07

Pharmacologic Class

Established (EPC)
central alpha-2 adrenergic agonist [epc]
Mechanism of Action
adrenergic alpha2-agonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 24979538
Hyphenated Format 24979-538

Supplemental Identifiers

RxCUI
862006 862013 862019 862025
UPC
0324979536019 0324979534015 0324979533018 0324979538013
UNII
30OMY4G3MK
NUI
N0000009918 N0000175554

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 ANDA201408 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 4 mg/1
source: ndc
Packaging
  • 100000 TABLET, EXTENDED RELEASE in 1 DRUM (24979-538-00)
  • 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (24979-538-01)
  • 1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (24979-538-10)
source: ndc

Packages (3)

24979-538-00 100000 TABLET, EXTENDED RELEASE in 1 DRUM (24979-538-00) 24979-538-01 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (24979-538-01) 24979-538-10 1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (24979-538-10)

Ingredients (1)

guanfacine (4 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": "6634768f-1e5a-4604-9587-fe5ffbd7e331", "openfda": {"nui": ["N0000009918", "N0000175554"], "upc": ["0324979536019", "0324979534015", "0324979533018", "0324979538013"], "unii": ["30OMY4G3MK"], "rxcui": ["862006", "862013", "862019", "862025"], "spl_set_id": ["07a701e2-39b7-4bb1-a7c7-d9baed4ab18a"], "pharm_class_epc": ["Central alpha-2 Adrenergic Agonist [EPC]"], "pharm_class_moa": ["Adrenergic alpha2-Agonists [MoA]"], "manufacturer_name": ["Upsher-Smith Laboratories, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100000 TABLET, EXTENDED RELEASE in 1 DRUM (24979-538-00)", "package_ndc": "24979-538-00", "marketing_start_date": "20240701"}, {"sample": false, "description": "100 TABLET, EXTENDED RELEASE in 1 BOTTLE (24979-538-01)", "package_ndc": "24979-538-01", "marketing_start_date": "20170707"}, {"sample": false, "description": "1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (24979-538-10)", "package_ndc": "24979-538-10", "marketing_start_date": "20170707"}], "brand_name": "Guanfacine Extended-Release", "product_id": "24979-538_6634768f-1e5a-4604-9587-fe5ffbd7e331", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Adrenergic alpha2-Agonists [MoA]", "Central alpha-2 Adrenergic Agonist [EPC]"], "product_ndc": "24979-538", "generic_name": "Guanfacine", "labeler_name": "Upsher-Smith Laboratories, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Guanfacine", "brand_name_suffix": "Extended-Release", "active_ingredients": [{"name": "GUANFACINE", "strength": "4 mg/1"}], "application_number": "ANDA201408", "marketing_category": "ANDA", "marketing_start_date": "20170707", "listing_expiration_date": "20261231"}