guanfacine hydrochloride

Generic: guanfacine

Labeler: precision dose, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name guanfacine hydrochloride
Generic Name guanfacine
Labeler precision dose, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

guanfacine hydrochloride 1 mg/1

Manufacturer
Precision Dose, Inc.

Identifiers & Regulatory

Product NDC 68094-065
Product ID 68094-065_370c543f-fc34-4fff-804c-3b990de04588
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA075109
Listing Expiration 2026-12-31
Marketing Start 2023-01-31

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 68094065
Hyphenated Format 68094-065

Supplemental Identifiers

RxCUI
197745
UPC
0368094065627
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 hydrochloride (source: ndc)
Generic Name guanfacine (source: ndc)
Application Number ANDA075109 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 1 mg/1
source: ndc
Packaging
  • 3 BLISTER PACK in 1 CARTON (68094-065-62) / 10 TABLET in 1 BLISTER PACK (68094-065-59)
source: ndc

Packages (1)

68094-065-62 3 BLISTER PACK in 1 CARTON (68094-065-62) / 10 TABLET in 1 BLISTER PACK (68094-065-59)

Ingredients (1)

guanfacine hydrochloride (1 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": "370c543f-fc34-4fff-804c-3b990de04588", "openfda": {"upc": ["0368094065627"], "unii": ["PML56A160O"], "rxcui": ["197745"], "spl_set_id": ["a80dfdc4-b9a7-4f8e-af67-dea30bc063ac"], "manufacturer_name": ["Precision Dose, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "3 BLISTER PACK in 1 CARTON (68094-065-62)  / 10 TABLET in 1 BLISTER PACK (68094-065-59)", "package_ndc": "68094-065-62", "marketing_start_date": "20230131"}], "brand_name": "Guanfacine Hydrochloride", "product_id": "68094-065_370c543f-fc34-4fff-804c-3b990de04588", "dosage_form": "TABLET", "pharm_class": ["Adrenergic alpha2-Agonists [MoA]", "Central alpha-2 Adrenergic Agonist [EPC]"], "product_ndc": "68094-065", "generic_name": "Guanfacine", "labeler_name": "Precision Dose, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Guanfacine Hydrochloride", "active_ingredients": [{"name": "GUANFACINE HYDROCHLORIDE", "strength": "1 mg/1"}], "application_number": "ANDA075109", "marketing_category": "ANDA", "marketing_start_date": "20230131", "listing_expiration_date": "20261231"}