guanfacine hydrochloride

Generic: guanfacine

Labeler: twi pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name guanfacine hydrochloride
Generic Name guanfacine
Labeler twi pharmaceuticals, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

guanfacine hydrochloride 2 mg/1

Manufacturer
TWi Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 24979-199
Product ID 24979-199_ef3592ef-2184-43de-9f37-062bd24079d6
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA216399
Listing Expiration 2026-12-31
Marketing Start 2022-09-01

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 24979199
Hyphenated Format 24979-199

Supplemental Identifiers

RxCUI
197745 197746
UPC
0324979199016 0324979198019
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 hydrochloride (source: ndc)
Generic Name guanfacine (source: ndc)
Application Number ANDA216399 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 2 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (24979-199-01)
source: ndc

Packages (1)

24979-199-01 100 TABLET in 1 BOTTLE (24979-199-01)

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": "ef3592ef-2184-43de-9f37-062bd24079d6", "openfda": {"upc": ["0324979199016", "0324979198019"], "unii": ["PML56A160O"], "rxcui": ["197745", "197746"], "spl_set_id": ["a0c2d95d-805c-4c7d-9733-52073a65218a"], "manufacturer_name": ["TWi Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (24979-199-01)", "package_ndc": "24979-199-01", "marketing_start_date": "20220901"}], "brand_name": "Guanfacine Hydrochloride", "product_id": "24979-199_ef3592ef-2184-43de-9f37-062bd24079d6", "dosage_form": "TABLET", "pharm_class": ["Adrenergic alpha2-Agonists [MoA]", "Central alpha-2 Adrenergic Agonist [EPC]"], "product_ndc": "24979-199", "generic_name": "Guanfacine", "labeler_name": "TWi Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Guanfacine Hydrochloride", "active_ingredients": [{"name": "GUANFACINE HYDROCHLORIDE", "strength": "2 mg/1"}], "application_number": "ANDA216399", "marketing_category": "ANDA", "marketing_start_date": "20220901", "listing_expiration_date": "20261231"}