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
Routes
ORAL
Active Ingredients

guanfacine hydrochloride 1 mg/1

Manufacturer
REMEDYREPACK INC.

Identifiers & Regulatory

Product NDC 70518-1369
Product ID 70518-1369_48ea1abe-4028-4b74-e063-6394a90aeade
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA074145
Listing Expiration 2027-12-31
Marketing Start 2018-08-10

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 705181369
Hyphenated Format 70518-1369

Supplemental Identifiers

RxCUI
197745
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 ANDA074145 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 1 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BLISTER PACK (70518-1369-0)
source: ndc

Packages (1)

70518-1369-0 30 TABLET in 1 BLISTER PACK (70518-1369-0)

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": "48ea1abe-4028-4b74-e063-6394a90aeade", "openfda": {"unii": ["PML56A160O"], "rxcui": ["197745"], "spl_set_id": ["b6b1d427-e19a-4fc1-b518-f58bacc46736"], "manufacturer_name": ["REMEDYREPACK INC."]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BLISTER PACK (70518-1369-0)", "package_ndc": "70518-1369-0", "marketing_start_date": "20180810"}], "brand_name": "Guanfacine", "product_id": "70518-1369_48ea1abe-4028-4b74-e063-6394a90aeade", "dosage_form": "TABLET", "pharm_class": ["Adrenergic alpha2-Agonists [MoA]", "Central alpha-2 Adrenergic Agonist [EPC]"], "product_ndc": "70518-1369", "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": "ANDA074145", "marketing_category": "ANDA", "marketing_start_date": "20180810", "listing_expiration_date": "20271231"}