FDA.reportPublic FDA data

Guanfacine

Product NDC
16714-190
11-digit product format
167140190
Labeler code
16714
Product ID
16714-190_2a3f66a1-c942-7bba-e063-6394a90a05a1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Guanfacine
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
NORTHSTAR RXLLC
Application
ANDA205689
Marketing category
ANDA
Marketing start
2021-09-17
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
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GUANFACINE HYDROCHLORIDE1 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiPML56A160O
Rxcui862006, 862013, 862019, 862025

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
16714-190-01Guanfacine100 in 1 BOTTLETABLET, EXTENDED RELEASE1004

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16714-190-01EA - Each16714-190d1833764-d894-4e34-974e-aba8bdf3f0b512021-12-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16714-190GUANFACINE TABLET, EXTENDED RELEASE [NORTHSTAR RXLLC]4Current NDC, Legacy NDC, 1 package rows20241228_0b2afdab-8c92-463e-9734-f2c8b4200777.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
862006guanFACINE 1 MG 24HR Extended Release Oral TabletPSN0b2afdab-8c92-463e-9734-f2c8b42007774
862013guanFACINE 2 MG 24HR Extended Release Oral TabletPSN0b2afdab-8c92-463e-9734-f2c8b42007774
862019guanFACINE 3 MG 24HR Extended Release Oral TabletPSN0b2afdab-8c92-463e-9734-f2c8b42007774
862025guanFACINE 4 MG 24HR Extended Release Oral TabletPSN0b2afdab-8c92-463e-9734-f2c8b42007774
86200624 HR guanfacine 1 MG Extended Release Oral TabletSCD0b2afdab-8c92-463e-9734-f2c8b42007774
86201324 HR guanfacine 2 MG Extended Release Oral TabletSCD0b2afdab-8c92-463e-9734-f2c8b42007774
86201924 HR guanfacine 3 MG Extended Release Oral TabletSCD0b2afdab-8c92-463e-9734-f2c8b42007774
86202524 HR guanfacine 4 MG Extended Release Oral TabletSCD0b2afdab-8c92-463e-9734-f2c8b42007774
862006guanfacine 1 MG (as guanfacine hydrochloride 1.14 MG) 24 HR Extended Release Oral TabletSY0b2afdab-8c92-463e-9734-f2c8b42007774
862006guanfacine 1 MG (as guanfacine hydrochloride 1.15 MG) 24 HR Extended Release Oral TabletSY0b2afdab-8c92-463e-9734-f2c8b42007774
862013guanfacine 2 MG (as guanfacine hydrochloride 2.28 MG) 24 HR Extended Release Oral TabletSY0b2afdab-8c92-463e-9734-f2c8b42007774
862013guanfacine 2 MG (as guanfacine hydrochloride 2.3 MG) 24 HR Extended Release Oral TabletSY0b2afdab-8c92-463e-9734-f2c8b42007774
862019guanfacine 3 MG (as guanfacine hydrochloride 3.42 MG) 24 HR Extended Release Oral TabletSY0b2afdab-8c92-463e-9734-f2c8b42007774
862019guanfacine 3 MG (as guanfacine hydrochloride 3.45 MG) 24 HR Extended Release Oral TabletSY0b2afdab-8c92-463e-9734-f2c8b42007774
862025guanfacine 4 MG (as guanfacine hydrochloride 4.56 MG) 24 HR Extended Release Oral TabletSY0b2afdab-8c92-463e-9734-f2c8b42007774
862025guanfacine 4 MG (as guanfacine hydrochloride 4.6 MG) 24 HR Extended Release Oral TabletSY0b2afdab-8c92-463e-9734-f2c8b42007774

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
16714-190-0116714019001100 TABLET, EXTENDED RELEASE in 1 BOTTLE (16714-190-01) 2021-09-170000-00-00NoNoCurrent