guanfacine

Generic: guanfacine

Labeler: remedyrepack inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name guanfacine
Generic Name guanfacine
Labeler remedyrepack inc.
Dosage Form TABLET, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

guanfacine hydrochloride 1 mg/1

Manufacturer
REMEDYREPACK INC.

Identifiers & Regulatory

Product NDC 70518-4539
Product ID 70518-4539_4858f0eb-08c7-1a50-e063-6394a90a4c5b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA219033
Listing Expiration 2027-12-31
Marketing Start 2025-12-23

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 705184539
Hyphenated Format 70518-4539

Supplemental Identifiers

RxCUI
862006
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 ANDA219033 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 1 mg/1
source: ndc
Packaging
  • 30 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (70518-4539-0)
source: ndc

Packages (1)

70518-4539-0 30 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (70518-4539-0)

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": "4858f0eb-08c7-1a50-e063-6394a90a4c5b", "openfda": {"unii": ["PML56A160O"], "rxcui": ["862006"], "spl_set_id": ["145a191d-9049-4014-9c42-503fdde063dc"], "manufacturer_name": ["REMEDYREPACK INC."]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (70518-4539-0)", "package_ndc": "70518-4539-0", "marketing_start_date": "20251223"}], "brand_name": "Guanfacine", "product_id": "70518-4539_4858f0eb-08c7-1a50-e063-6394a90a4c5b", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Adrenergic alpha2-Agonists [MoA]", "Central alpha-2 Adrenergic Agonist [EPC]"], "product_ndc": "70518-4539", "generic_name": "Guanfacine", "labeler_name": "REMEDYREPACK INC.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Guanfacine", "active_ingredients": [{"name": "GUANFACINE HYDROCHLORIDE", "strength": "1 mg/1"}], "application_number": "ANDA219033", "marketing_category": "ANDA", "marketing_start_date": "20251223", "listing_expiration_date": "20271231"}