guanfacine

Generic: guanfacine

Labeler: slate run pharmaceuticals, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name guanfacine
Generic Name guanfacine
Labeler slate run pharmaceuticals, llc
Dosage Form TABLET, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

guanfacine hydrochloride 4 mg/1

Manufacturer
Slate Run Pharmaceuticals, LLC

Identifiers & Regulatory

Product NDC 70436-042
Product ID 70436-042_44e07739-2e64-f744-e063-6394a90ab3ac
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA213428
Listing Expiration 2026-12-31
Marketing Start 2022-08-01

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 70436042
Hyphenated Format 70436-042

Supplemental Identifiers

RxCUI
862006 862013 862019 862025
UPC
0370436039012 0370436042012 0370436041015 0370436040018
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 ANDA213428 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 4 mg/1
source: ndc
Packaging
  • 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (70436-042-01)
source: ndc

Packages (1)

70436-042-01 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (70436-042-01)

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": "44e07739-2e64-f744-e063-6394a90ab3ac", "openfda": {"upc": ["0370436039012", "0370436042012", "0370436041015", "0370436040018"], "unii": ["PML56A160O"], "rxcui": ["862006", "862013", "862019", "862025"], "spl_set_id": ["ed65ca51-b9b0-43b9-9826-03a7be256a2a"], "manufacturer_name": ["Slate Run Pharmaceuticals, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, EXTENDED RELEASE in 1 BOTTLE (70436-042-01)", "package_ndc": "70436-042-01", "marketing_start_date": "20220801"}], "brand_name": "Guanfacine", "product_id": "70436-042_44e07739-2e64-f744-e063-6394a90ab3ac", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Adrenergic alpha2-Agonists [MoA]", "Central alpha-2 Adrenergic Agonist [EPC]"], "product_ndc": "70436-042", "generic_name": "guanfacine", "labeler_name": "Slate Run Pharmaceuticals, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Guanfacine", "active_ingredients": [{"name": "GUANFACINE HYDROCHLORIDE", "strength": "4 mg/1"}], "application_number": "ANDA213428", "marketing_category": "ANDA", "marketing_start_date": "20220801", "listing_expiration_date": "20261231"}