FDA.reportPublic FDA data

Guanfacine

Product NDC
27241-243
11-digit product format
272410243
Labeler code
27241
Product ID
27241-243_de4816b4-f03b-4b28-ac3d-979c166b4c9c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Guanfacine
Dosage form
TABLET
Route
ORAL
Labeler
Ajanta Pharma USA Inc.
Application
ANDA217293
Marketing category
ANDA
Marketing start
2023-04-27
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
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 HYDROCHLORIDE2 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
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
27241-243-01Guanfacine100 in 1 BOTTLETABLET1004

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
27241-243-01EA - Each27241-2433aa7cf28-2ea2-40ef-95e1-971532b7b93c12023-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
27241-243GUANFACINE TABLET [AJANTA PHARMA USA INC.]3Current NDC, 1 package rows20240601_830c0be8-2137-46ee-94c6-aa048b7de35f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197745guanFACINE HCl 1 MG Oral TabletPSN830c0be8-2137-46ee-94c6-aa048b7de35f4
197746guanFACINE HCl 2 MG Oral TabletPSN830c0be8-2137-46ee-94c6-aa048b7de35f4
197745guanfacine 1 MG Oral TabletSCD830c0be8-2137-46ee-94c6-aa048b7de35f4
197746guanfacine 2 MG Oral TabletSCD830c0be8-2137-46ee-94c6-aa048b7de35f4
197745guanfacine 1 MG (as guanfacine HCl 1.15 MG) Oral TabletSY830c0be8-2137-46ee-94c6-aa048b7de35f4
197746guanfacine 2 MG (as guanfacine HCl 2.3 MG) Oral TabletSY830c0be8-2137-46ee-94c6-aa048b7de35f4
197746guanFACINE HCl 2 MG Oral TabletPSN4248d53e-4dc3-452b-96f8-5d715c254c261
197746guanFACINE HCl 2 MG Oral TabletPSN4973deb3-57ec-1ef3-e063-6294a90aa0351
197746guanfacine 2 MG Oral TabletSCD4248d53e-4dc3-452b-96f8-5d715c254c261
197746guanfacine 2 MG Oral TabletSCD4973deb3-57ec-1ef3-e063-6294a90aa0351
197746guanfacine 2 MG (as guanfacine HCl 2.3 MG) Oral TabletSY4248d53e-4dc3-452b-96f8-5d715c254c261
197746guanfacine 2 MG (as guanfacine HCl 2.3 MG) Oral TabletSY4973deb3-57ec-1ef3-e063-6294a90aa0351

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
27241-243-0127241024301100 TABLET in 1 BOTTLE (27241-243-01) 100 tablet2023-04-27NoNoCurrent