FDA.reportPublic FDA data

GEMTESA

Product NDC
73336-075
11-digit product format
733360075
Labeler code
73336
Product ID
73336-075_6744a1cf-7abb-4623-85e3-8f67a9eb19d4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
vibegron
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Sumitomo Pharma America, Inc.
Application
NDA213006
Marketing category
NDA
Marketing start
2020-12-29
Substance
VIBEGRON
Active strength
75 mg/1
Pharmacologic classes
Adrenergic beta3-Agonists [MoA], beta3-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
GEMTESA
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
VIBEGRON75 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiM5TSE03W5U
Rxcui2472315, 2472321

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ba7af2ad-3b19-4bfc-8565-d06d002febf2Product name120210610
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73336-075-07GEMTESA1 in 1 CARTONTABLET, FILM COATED112
73336-075-07GEMTESA7 in 1 BOTTLETABLET, FILM COATED712
73336-075-30GEMTESA30 in 1 BOTTLETABLET, FILM COATED3012
73336-075-90GEMTESA90 in 1 BOTTLETABLET, FILM COATED9012

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
73336-075-30EA - Each73336-075f6b7ef54-78da-4722-9449-735b53ff880312021-02-05
73336-075-90EA - Each73336-07539bf4d29-7033-4227-b368-4bef4d373fc212022-01-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73336-075GEMTESA (VIBEGRON) TABLET, FILM COATED [SUMITOMO PHARMA AMERICA, INC. ]12Current NDC, Legacy NDC, 4 package rows20250409_25f21d25-14f8-4fda-91f6-7aa8b68aa1c8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2472321GEMTESA 75 MG Once-Daily Oral TabletPSN25f21d25-14f8-4fda-91f6-7aa8b68aa1c812
2472315vibegron 75 MG Once-Daily Oral TabletPSN25f21d25-14f8-4fda-91f6-7aa8b68aa1c812
2472321vibegron 75 MG Oral Tablet [Gemtesa]SBD25f21d25-14f8-4fda-91f6-7aa8b68aa1c812
2472315vibegron 75 MG Oral TabletSCD25f21d25-14f8-4fda-91f6-7aa8b68aa1c812
2472321Gemtesa 75 MG Oral TabletSY25f21d25-14f8-4fda-91f6-7aa8b68aa1c812

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
73336-075-07733360075071 BOTTLE in 1 CARTON (73336-075-07) / 7 TABLET, FILM COATED in 1 BOTTLE1 bottle2020-12-290000-00-00NoNoCurrent
73336-075-307333600753030 TABLET, FILM COATED in 1 BOTTLE (73336-075-30) 2020-12-290000-00-00NoNoCurrent
73336-075-907333600759090 TABLET, FILM COATED in 1 BOTTLE (73336-075-90) 2020-12-290000-00-00NoNoCurrent