guanfacine hydrochloride

Generic: guanfacine

Labeler: avpak
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name guanfacine hydrochloride
Generic Name guanfacine
Labeler avpak
Dosage Form TABLET
Routes
ORAL
Active Ingredients

guanfacine hydrochloride 2 mg/1

Manufacturer
AvPAK

Identifiers & Regulatory

Product NDC 50268-374
Product ID 50268-374_4b96421c-395d-065d-e063-6294a90a330b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA075109
Listing Expiration 2027-12-31
Marketing Start 2017-06-07

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 50268374
Hyphenated Format 50268-374

Supplemental Identifiers

RxCUI
197745 197746
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
  • 2 mg/1
source: ndc
Packaging
  • 50 BLISTER PACK in 1 BOX, UNIT-DOSE (50268-374-15) / 1 TABLET in 1 BLISTER PACK (50268-374-11)
source: ndc

Packages (1)

50268-374-15 50 BLISTER PACK in 1 BOX, UNIT-DOSE (50268-374-15) / 1 TABLET in 1 BLISTER PACK (50268-374-11)

Ingredients (1)

guanfacine hydrochloride (2 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": "4b96421c-395d-065d-e063-6294a90a330b", "openfda": {"unii": ["PML56A160O"], "rxcui": ["197745", "197746"], "spl_set_id": ["cc3cc6de-583c-4180-9f4c-9e4c75eb6f38"], "manufacturer_name": ["AvPAK"]}, "finished": true, "packaging": [{"sample": false, "description": "50 BLISTER PACK in 1 BOX, UNIT-DOSE (50268-374-15)  / 1 TABLET in 1 BLISTER PACK (50268-374-11)", "package_ndc": "50268-374-15", "marketing_start_date": "20170607"}], "brand_name": "Guanfacine Hydrochloride", "product_id": "50268-374_4b96421c-395d-065d-e063-6294a90a330b", "dosage_form": "TABLET", "pharm_class": ["Adrenergic alpha2-Agonists [MoA]", "Central alpha-2 Adrenergic Agonist [EPC]"], "product_ndc": "50268-374", "generic_name": "Guanfacine", "labeler_name": "AvPAK", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Guanfacine Hydrochloride", "active_ingredients": [{"name": "GUANFACINE HYDROCHLORIDE", "strength": "2 mg/1"}], "application_number": "ANDA075109", "marketing_category": "ANDA", "marketing_start_date": "20170607", "listing_expiration_date": "20271231"}