guanfacine

Generic: guanfacine

Labeler: alembic pharmaceuticals limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name guanfacine
Generic Name guanfacine
Labeler alembic pharmaceuticals limited
Dosage Form TABLET, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

guanfacine hydrochloride 4 mg/1

Manufacturer
Alembic Pharmaceuticals Limited

Identifiers & Regulatory

Product NDC 46708-748
Product ID 46708-748_983b3157-cbea-435d-ba32-9ee7ef95226a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA217269
Listing Expiration 2026-12-31
Marketing Start 2023-08-08

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 46708748
Hyphenated Format 46708-748

Supplemental Identifiers

RxCUI
862006 862013 862019 862025
UPC
0346708746315 0346708745318 0346708748319 0346708747312
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 ANDA217269 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 4 mg/1
source: ndc
Packaging
  • 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (46708-748-31)
  • 1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (46708-748-91)
source: ndc

Packages (2)

46708-748-31 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (46708-748-31) 46708-748-91 1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (46708-748-91)

Ingredients (1)

guanfacine hydrochloride (4 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": "983b3157-cbea-435d-ba32-9ee7ef95226a", "openfda": {"upc": ["0346708746315", "0346708745318", "0346708748319", "0346708747312"], "unii": ["PML56A160O"], "rxcui": ["862006", "862013", "862019", "862025"], "spl_set_id": ["983b3157-cbea-435d-ba32-9ee7ef95226a"], "manufacturer_name": ["Alembic Pharmaceuticals Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, EXTENDED RELEASE in 1 BOTTLE (46708-748-31)", "package_ndc": "46708-748-31", "marketing_start_date": "20230808"}, {"sample": false, "description": "1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (46708-748-91)", "package_ndc": "46708-748-91", "marketing_start_date": "20230808"}], "brand_name": "GUANFACINE", "product_id": "46708-748_983b3157-cbea-435d-ba32-9ee7ef95226a", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Adrenergic alpha2-Agonists [MoA]", "Central alpha-2 Adrenergic Agonist [EPC]"], "product_ndc": "46708-748", "generic_name": "GUANFACINE", "labeler_name": "Alembic Pharmaceuticals Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "GUANFACINE", "active_ingredients": [{"name": "GUANFACINE HYDROCHLORIDE", "strength": "4 mg/1"}], "application_number": "ANDA217269", "marketing_category": "ANDA", "marketing_start_date": "20230808", "listing_expiration_date": "20261231"}