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 72189-469
Product ID 72189-469_2c4def88-252f-7c8b-e063-6294a90aeb94
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA205430
Listing Expiration 2026-12-31
Marketing Start 2023-05-04

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 72189469
Hyphenated Format 72189-469

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 ANDA205430 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 1 mg/1
source: ndc
Packaging
  • 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (72189-469-30)
source: ndc

Packages (1)

72189-469-30 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (72189-469-30)

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": "2c4def88-252f-7c8b-e063-6294a90aeb94", "openfda": {"unii": ["PML56A160O"], "rxcui": ["862006"], "spl_set_id": ["fae2df3c-2298-a3e1-e053-6294a90aeac4"], "manufacturer_name": ["Direct_Rx"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, EXTENDED RELEASE in 1 BOTTLE (72189-469-30)", "package_ndc": "72189-469-30", "marketing_start_date": "20230504"}], "brand_name": "Guanfacine ER", "product_id": "72189-469_2c4def88-252f-7c8b-e063-6294a90aeb94", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Adrenergic alpha2-Agonists [MoA]", "Central alpha-2 Adrenergic Agonist [EPC]"], "product_ndc": "72189-469", "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": "ANDA205430", "marketing_category": "ANDA", "marketing_start_date": "20230504", "listing_expiration_date": "20261231"}