guanfacine

Generic: guanfacine

Labeler: avkare
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

guanfacine hydrochloride 4 mg/1

Manufacturer
AvKARE

Identifiers & Regulatory

Product NDC 42291-327
Product ID 42291-327_435760cc-e7f3-28b9-e063-6294a90a7004
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA200881
Listing Expiration 2026-12-31
Marketing Start 2015-07-09

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 42291327
Hyphenated Format 42291-327

Supplemental Identifiers

RxCUI
862006 862013 862019 862025
UPC
0342291327016 0342291325012
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 ANDA200881 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 4 mg/1
source: ndc
Packaging
  • 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (42291-327-01)
source: ndc

Packages (1)

42291-327-01 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (42291-327-01)

Ingredients (1)

guanfacine hydrochloride (4 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": "435760cc-e7f3-28b9-e063-6294a90a7004", "openfda": {"upc": ["0342291327016", "0342291325012"], "unii": ["PML56A160O"], "rxcui": ["862006", "862013", "862019", "862025"], "spl_set_id": ["301f01a7-2b0a-cfba-9c3d-a1dd831785a3"], "manufacturer_name": ["AvKARE"]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, EXTENDED RELEASE in 1 BOTTLE (42291-327-01)", "package_ndc": "42291-327-01", "marketing_start_date": "20150709"}], "brand_name": "guanfacine", "product_id": "42291-327_435760cc-e7f3-28b9-e063-6294a90a7004", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Adrenergic alpha2-Agonists [MoA]", "Central alpha-2 Adrenergic Agonist [EPC]"], "product_ndc": "42291-327", "generic_name": "guanfacine", "labeler_name": "AvKARE", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "guanfacine", "active_ingredients": [{"name": "GUANFACINE HYDROCHLORIDE", "strength": "4 mg/1"}], "application_number": "ANDA200881", "marketing_category": "ANDA", "marketing_start_date": "20150709", "listing_expiration_date": "20261231"}