Guanfacine

Product NDC
70518-4488
11-digit product format
705184488
Labeler code
70518
Product ID
70518-4488_4009ab4c-4e58-ea2b-e063-6294a90a26f3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Guanfacine
Dosage form
TABLET
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA217293
Marketing category
ANDA
Marketing start
2025-09-30
Substance
GUANFACINE HYDROCHLORIDE
Active strength
2 mg/1
Pharmacologic classes
Adrenergic alpha2-Agonists [MoA], Central alpha-2 Adrenergic Agonist [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Guanfacine
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GUANFACINE HYDROCHLORIDE2 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiPML56A160O
Rxcui197746

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
44b80df7-57c9-56d4-c87a-f0d57d327460Product name920260127
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
4e3af9ef-fc83-b9f5-a7ba-995eabf1f1f0Product name320230308
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70518-4488-0Guanfacine30 in 1 BLISTER PACKTABLET301

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197746guanFACINE HCl 2 MG Oral TabletPSN4248d53e-4dc3-452b-96f8-5d715c254c261
197746guanfacine 2 MG Oral TabletSCD4248d53e-4dc3-452b-96f8-5d715c254c261
197746guanfacine 2 MG (as guanfacine HCl 2.3 MG) Oral TabletSY4248d53e-4dc3-452b-96f8-5d715c254c261

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70518-4488-07051844880030 TABLET in 1 BLISTER PACK (70518-4488-0) 30 tablet2025-09-30NoNoHistorical