FDA.reportPublic FDA data

Guanfacine Hydrochloride

Product NDC
70700-301
11-digit product format
707000301
Labeler code
70700
Product ID
70700-301_23ee7a86-0dc4-c845-93ff-f02aab00ce8f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Guanfacine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
XIROMED, LLC
Application
ANDA218326
Marketing category
ANDA
Marketing start
2024-02-24
Substance
GUANFACINE HYDROCHLORIDE
Active strength
1 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 Hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GUANFACINE HYDROCHLORIDE1 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiPML56A160O
Rxcui197745, 197746

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
44b80df7-57c9-56d4-c87a-f0d57d327460Product name920260127
4e3af9ef-fc83-b9f5-a7ba-995eabf1f1f0Product name320230308

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70700-301-01Guanfacine Hydrochloride100 in 1 BOTTLETABLET1002
70700-301-30Guanfacine Hydrochloride30 in 1 BOTTLETABLET302

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70700-301-01EA - Each70700-30166f0e985-da20-4651-adcb-3561a6cf4c2912024-04-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70700-301GUANFACINE HYDROCHLORIDE TABLET [XIROMED, LLC]2Current NDC, 2 package rows20240328_4f1e668a-37dd-44f4-ae99-3a1f6dba3eea.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197745guanFACINE HCl 1 MG Oral TabletPSN4f1e668a-37dd-44f4-ae99-3a1f6dba3eea2
197746guanFACINE HCl 2 MG Oral TabletPSN4f1e668a-37dd-44f4-ae99-3a1f6dba3eea2
197745guanfacine 1 MG Oral TabletSCD4f1e668a-37dd-44f4-ae99-3a1f6dba3eea2
197746guanfacine 2 MG Oral TabletSCD4f1e668a-37dd-44f4-ae99-3a1f6dba3eea2
197745guanfacine 1 MG (as guanfacine HCl 1.15 MG) Oral TabletSY4f1e668a-37dd-44f4-ae99-3a1f6dba3eea2
197746guanfacine 2 MG (as guanfacine HCl 2.3 MG) Oral TabletSY4f1e668a-37dd-44f4-ae99-3a1f6dba3eea2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70700-301-0170700030101100 TABLET in 1 BOTTLE (70700-301-01) 100 tablet2024-02-24NoNoCurrent
70700-301-307070003013030 TABLET in 1 BOTTLE (70700-301-30) 30 tablet2024-02-24NoNoCurrent