guanfacine

Generic: gaunfacine

Labeler: i3 pharmaceuticals, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name guanfacine
Generic Name gaunfacine
Labeler i3 pharmaceuticals, llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

guanfacine hydrochloride 1 mg/1

Manufacturer
i3 Pharmaceuticals, LLC

Identifiers & Regulatory

Product NDC 72319-018
Product ID 72319-018_262d9624-c761-8f3d-e063-6394a90a2640
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA216828
Listing Expiration 2026-12-31
Marketing Start 2022-10-31

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 72319018
Hyphenated Format 72319-018

Supplemental Identifiers

RxCUI
197745 197746
UPC
0372319019043 0372319018046
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 gaunfacine (source: ndc)
Application Number ANDA216828 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 1 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (72319-018-04)
source: ndc

Packages (1)

72319-018-04 100 TABLET in 1 BOTTLE (72319-018-04)

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": "262d9624-c761-8f3d-e063-6394a90a2640", "openfda": {"upc": ["0372319019043", "0372319018046"], "unii": ["PML56A160O"], "rxcui": ["197745", "197746"], "spl_set_id": ["387b33dd-829d-4dab-afe4-078fd1559027"], "manufacturer_name": ["i3 Pharmaceuticals, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (72319-018-04)", "package_ndc": "72319-018-04", "marketing_start_date": "20221031"}], "brand_name": "Guanfacine", "product_id": "72319-018_262d9624-c761-8f3d-e063-6394a90a2640", "dosage_form": "TABLET", "pharm_class": ["Adrenergic alpha2-Agonists [MoA]", "Central alpha-2 Adrenergic Agonist [EPC]"], "product_ndc": "72319-018", "generic_name": "Gaunfacine", "labeler_name": "i3 Pharmaceuticals, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Guanfacine", "active_ingredients": [{"name": "GUANFACINE HYDROCHLORIDE", "strength": "1 mg/1"}], "application_number": "ANDA216828", "marketing_category": "ANDA", "marketing_start_date": "20221031", "listing_expiration_date": "20261231"}