guanfacine

Generic: guanfacine

Labeler: coupler llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name guanfacine
Generic Name guanfacine
Labeler coupler llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

guanfacine hydrochloride 2 mg/1

Manufacturer
Coupler LLC

Identifiers & Regulatory

Product NDC 67046-1655
Product ID 67046-1655_4973ca2b-3a76-d8d0-e063-6394a90a9d0e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA217293
Listing Expiration 2027-12-31
Marketing Start 2026-01-28

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 670461655
Hyphenated Format 67046-1655

Supplemental Identifiers

RxCUI
197746
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 (source: ndc)
Generic Name guanfacine (source: ndc)
Application Number ANDA217293 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 2 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BLISTER PACK (67046-1655-3)
source: ndc

Packages (1)

67046-1655-3 30 TABLET in 1 BLISTER PACK (67046-1655-3)

Ingredients (1)

guanfacine hydrochloride (2 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": "4973ca2b-3a76-d8d0-e063-6394a90a9d0e", "openfda": {"unii": ["PML56A160O"], "rxcui": ["197746"], "spl_set_id": ["4973deb3-57ec-1ef3-e063-6294a90aa035"], "manufacturer_name": ["Coupler LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BLISTER PACK (67046-1655-3)", "package_ndc": "67046-1655-3", "marketing_start_date": "20260128"}], "brand_name": "Guanfacine", "product_id": "67046-1655_4973ca2b-3a76-d8d0-e063-6394a90a9d0e", "dosage_form": "TABLET", "pharm_class": ["Adrenergic alpha2-Agonists [MoA]", "Central alpha-2 Adrenergic Agonist [EPC]"], "product_ndc": "67046-1655", "generic_name": "Guanfacine", "labeler_name": "Coupler LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Guanfacine", "active_ingredients": [{"name": "GUANFACINE HYDROCHLORIDE", "strength": "2 mg/1"}], "application_number": "ANDA217293", "marketing_category": "ANDA", "marketing_start_date": "20260128", "listing_expiration_date": "20271231"}