Guanfacine

Product NDC
0904-7140
11-digit product format
009047140
Labeler code
0904
Product ID
0904-7140_eaf671db-1fc7-4923-af07-99aea483d91a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Guanfacine
Dosage form
TABLET
Route
ORAL
Labeler
Major Pharmaceuticals
Application
ANDA074673
Marketing category
ANDA
Marketing start
2013-12-02
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Guanfacine
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GUANFACINE HYDROCHLORIDE1 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiPML56A160O
Rxcui197745

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
0904-7140-04Guanfacine30 in 1 CARTONTABLET305
0904-7140-04Guanfacine1 in 1 BLISTER PACKTABLET15

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-7140-04EA - Each0904-714052235c84-5a85-47f6-9896-22deac933fd312023-04-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0904-7140GUANFACINE TABLET [MAJOR PHARMACEUTICALS]3Current NDC, Legacy NDC, 2 package rows20240906_400be431-ad6c-4783-a513-ca8b47bf43ee.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197745guanFACINE HCl 1 MG Oral TabletPSN400be431-ad6c-4783-a513-ca8b47bf43ee5
197745guanfacine 1 MG Oral TabletSCD400be431-ad6c-4783-a513-ca8b47bf43ee5
197745guanfacine 1 MG (as guanfacine HCl 1.15 MG) Oral TabletSY400be431-ad6c-4783-a513-ca8b47bf43ee5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0904-7140-040090471400430 BLISTER PACK in 1 CARTON (0904-7140-04) / 1 TABLET in 1 BLISTER PACK30 blister pack2013-12-020000-00-00NoNoCurrent