guanfacine

Generic: guanfacine

Labeler: ajanta pharma usa inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name guanfacine
Generic Name guanfacine
Labeler ajanta pharma usa inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

guanfacine hydrochloride 2 mg/1

Manufacturer
Ajanta Pharma USA Inc.

Identifiers & Regulatory

Product NDC 27241-243
Product ID 27241-243_de4816b4-f03b-4b28-ac3d-979c166b4c9c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA217293
Listing Expiration 2027-12-31
Marketing Start 2023-04-27

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 27241243
Hyphenated Format 27241-243

Supplemental Identifiers

RxCUI
197745 197746
UPC
0327241243011 0327241242014
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 ANDA217293 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 2 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (27241-243-01)
source: ndc

Packages (1)

27241-243-01 100 TABLET in 1 BOTTLE (27241-243-01)

Ingredients (1)

guanfacine hydrochloride (2 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": "de4816b4-f03b-4b28-ac3d-979c166b4c9c", "openfda": {"upc": ["0327241243011", "0327241242014"], "unii": ["PML56A160O"], "rxcui": ["197745", "197746"], "spl_set_id": ["830c0be8-2137-46ee-94c6-aa048b7de35f"], "manufacturer_name": ["Ajanta Pharma USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (27241-243-01)", "package_ndc": "27241-243-01", "marketing_start_date": "20230427"}], "brand_name": "Guanfacine", "product_id": "27241-243_de4816b4-f03b-4b28-ac3d-979c166b4c9c", "dosage_form": "TABLET", "pharm_class": ["Adrenergic alpha2-Agonists [MoA]", "Central alpha-2 Adrenergic Agonist [EPC]"], "product_ndc": "27241-243", "generic_name": "Guanfacine", "labeler_name": "Ajanta Pharma USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Guanfacine", "active_ingredients": [{"name": "GUANFACINE HYDROCHLORIDE", "strength": "2 mg/1"}], "application_number": "ANDA217293", "marketing_category": "ANDA", "marketing_start_date": "20230427", "listing_expiration_date": "20271231"}