guanfacine hydrochloride

Generic: guanfacine hydrochloride

Labeler: northstar rx llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name guanfacine hydrochloride
Generic Name guanfacine hydrochloride
Labeler northstar rx llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

guanfacine hydrochloride 2 mg/1

Manufacturer
NORTHSTAR RX LLC

Identifiers & Regulatory

Product NDC 72603-269
Product ID 72603-269_34444967-f5f1-a36d-a394-95e01c65eb8f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA218326
Listing Expiration 2026-12-31
Marketing Start 2024-07-15

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 72603269
Hyphenated Format 72603-269

Supplemental Identifiers

RxCUI
197745 197746
UPC
0372603268010
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 hydrochloride (source: ndc)
Generic Name guanfacine hydrochloride (source: ndc)
Application Number ANDA218326 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 2 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (72603-269-01)
source: ndc

Packages (1)

72603-269-01 100 TABLET in 1 BOTTLE (72603-269-01)

Ingredients (1)

guanfacine hydrochloride (2 mg/1)

Linked Drug Pages (1)

Guanfacine Hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "34444967-f5f1-a36d-a394-95e01c65eb8f", "openfda": {"upc": ["0372603268010"], "unii": ["PML56A160O"], "rxcui": ["197745", "197746"], "spl_set_id": ["83d0739b-46fd-6228-e85c-089611067a35"], "manufacturer_name": ["NORTHSTAR RX LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (72603-269-01)", "package_ndc": "72603-269-01", "marketing_start_date": "20240715"}], "brand_name": "Guanfacine Hydrochloride", "product_id": "72603-269_34444967-f5f1-a36d-a394-95e01c65eb8f", "dosage_form": "TABLET", "pharm_class": ["Adrenergic alpha2-Agonists [MoA]", "Central alpha-2 Adrenergic Agonist [EPC]"], "product_ndc": "72603-269", "generic_name": "Guanfacine Hydrochloride", "labeler_name": "NORTHSTAR RX LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Guanfacine Hydrochloride", "active_ingredients": [{"name": "GUANFACINE HYDROCHLORIDE", "strength": "2 mg/1"}], "application_number": "ANDA218326", "marketing_category": "ANDA", "marketing_start_date": "20240715", "listing_expiration_date": "20261231"}