guanfacine

Generic: guanfacine

Labeler: epic pharma, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name guanfacine
Generic Name guanfacine
Labeler epic pharma, llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

guanfacine hydrochloride 1 mg/1

Manufacturer
Epic Pharma, LLC

Identifiers & Regulatory

Product NDC 42806-048
Product ID 42806-048_d0ca35de-12e8-4154-825a-c82eed36efd7
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA074673
Listing Expiration 2026-12-31
Marketing Start 2013-12-02

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 42806048
Hyphenated Format 42806-048

Supplemental Identifiers

RxCUI
197745 197746
UNII
PML56A160O

Packaging Origin

Original Packager
true

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 ANDA074673 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 1 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (42806-048-01)
source: ndc

Packages (1)

42806-048-01 100 TABLET in 1 BOTTLE (42806-048-01)

Ingredients (1)

guanfacine hydrochloride (1 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": "d0ca35de-12e8-4154-825a-c82eed36efd7", "openfda": {"unii": ["PML56A160O"], "rxcui": ["197745", "197746"], "spl_set_id": ["fac4a4c2-f5f0-46ef-b76b-315abe9136fa"], "manufacturer_name": ["Epic Pharma, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (42806-048-01)", "package_ndc": "42806-048-01", "marketing_start_date": "20131202"}], "brand_name": "Guanfacine", "product_id": "42806-048_d0ca35de-12e8-4154-825a-c82eed36efd7", "dosage_form": "TABLET", "pharm_class": ["Adrenergic alpha2-Agonists [MoA]", "Central alpha-2 Adrenergic Agonist [EPC]"], "product_ndc": "42806-048", "generic_name": "Guanfacine", "labeler_name": "Epic Pharma, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Guanfacine", "active_ingredients": [{"name": "GUANFACINE HYDROCHLORIDE", "strength": "1 mg/1"}], "application_number": "ANDA074673", "marketing_category": "ANDA", "marketing_start_date": "20131202", "listing_expiration_date": "20261231"}