guanfacine er

Generic: guanfacine er

Labeler: direct_rx
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name guanfacine er
Generic Name guanfacine er
Labeler direct_rx
Dosage Form TABLET, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

guanfacine hydrochloride 1 mg/1

Manufacturer
Direct_rx

Identifiers & Regulatory

Product NDC 72189-597
Product ID 72189-597_286214e2-a65c-f43b-e063-6394a90a33be
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA217269
Listing Expiration 2026-12-31
Marketing Start 2024-12-03

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 72189597
Hyphenated Format 72189-597

Supplemental Identifiers

RxCUI
862006
UNII
PML56A160O

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 er (source: ndc)
Generic Name guanfacine er (source: ndc)
Application Number ANDA217269 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 1 mg/1
source: ndc
Packaging
  • 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (72189-597-30)
source: ndc

Packages (1)

72189-597-30 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (72189-597-30)

Ingredients (1)

guanfacine hydrochloride (1 mg/1)

Linked Drug Pages (1)

Guanfacine ER ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "286214e2-a65c-f43b-e063-6394a90a33be", "openfda": {"unii": ["PML56A160O"], "rxcui": ["862006"], "spl_set_id": ["286214e2-a65b-f43b-e063-6394a90a33be"], "manufacturer_name": ["Direct_rx"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, EXTENDED RELEASE in 1 BOTTLE (72189-597-30)", "package_ndc": "72189-597-30", "marketing_start_date": "20241203"}], "brand_name": "Guanfacine ER", "product_id": "72189-597_286214e2-a65c-f43b-e063-6394a90a33be", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Adrenergic alpha2-Agonists [MoA]", "Central alpha-2 Adrenergic Agonist [EPC]"], "product_ndc": "72189-597", "generic_name": "Guanfacine ER", "labeler_name": "Direct_rx", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Guanfacine ER", "active_ingredients": [{"name": "GUANFACINE HYDROCHLORIDE", "strength": "1 mg/1"}], "application_number": "ANDA217269", "marketing_category": "ANDA", "marketing_start_date": "20241203", "listing_expiration_date": "20261231"}