FDA.reportPublic FDA data

STEGLATRO

Product NDC
0006-5363
11-digit product format
000065363
Labeler code
0006
Product ID
0006-5363_1616eabd-2ed5-4a98-b255-964e73b63dc8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ertugliflozin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Merck Sharp & Dohme LLC
Application
NDA209803
Marketing category
NDA
Marketing start
2017-12-19
Substance
ERTUGLIFLOZIN PIDOLATE
Active strength
5 mg/1
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
STEGLATRO
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ERTUGLIFLOZIN PIDOLATE5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiMLU731K321
Rxcui1992810, 1992816, 1992819, 1992821

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
63c50ce2-9db8-486b-bf11-659e923f6f07Product name220250331
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
e1ede89f-54c8-428f-ae84-9e8a2deb67dbProduct name120180306
fd232072-39c4-4416-9b66-265d18a7bd93Product name120180306
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0006-5363-03STEGLATRO30 in 1 BOTTLETABLET, FILM COATED3016
0006-5363-06STEGLATRO90 in 1 BOTTLETABLET, FILM COATED9016
0006-5363-07STEGLATRO500 in 1 BOTTLETABLET, FILM COATED50016
0006-5363-08STEGLATRO7 in 1 BOTTLETABLET, FILM COATED716
0006-5363-09STEGLATRO2 in 1 CARTONTABLET, FILM COATED216
0006-5363-10STEGLATRO30 in 1 BOTTLETABLET, FILM COATED3016

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0006-5363-03EA - Each0006-536339535e37-f5d0-48ba-a708-85f6a4a5818912018-01-12
0006-5363-06EA - Each0006-5363b540f2ad-1847-4e7a-b0e7-c67f6c33be7412018-01-12
0006-5363-07EA - Each0006-536373213a19-039e-4928-88b2-2fde2b6550f112018-01-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0006-5363STEGLATRO (ERTUGLIFLOZIN) TABLET, FILM COATED [MERCK SHARP & DOHME LLC]16Current NDC, Legacy NDC, 6 package rows20250112_e6f3e718-bb99-48f1-ab94-b9f0af05fed6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1992819ertugliflozin 15 MG Oral TabletPSNe6f3e718-bb99-48f1-ab94-b9f0af05fed616
1992810ertugliflozin 5 MG Oral TabletPSNe6f3e718-bb99-48f1-ab94-b9f0af05fed616
1992821Steglatro 15 MG Oral TabletPSNe6f3e718-bb99-48f1-ab94-b9f0af05fed616
1992816Steglatro 5 MG Oral TabletPSNe6f3e718-bb99-48f1-ab94-b9f0af05fed616
1992821ertugliflozin 15 MG Oral Tablet [Steglatro]SBDe6f3e718-bb99-48f1-ab94-b9f0af05fed616
1992816ertugliflozin 5 MG Oral Tablet [Steglatro]SBDe6f3e718-bb99-48f1-ab94-b9f0af05fed616
1992819ertugliflozin 15 MG Oral TabletSCDe6f3e718-bb99-48f1-ab94-b9f0af05fed616
1992810ertugliflozin 5 MG Oral TabletSCDe6f3e718-bb99-48f1-ab94-b9f0af05fed616
1992821Steglatro 15 MG Oral TabletSYe6f3e718-bb99-48f1-ab94-b9f0af05fed616
1992816Steglatro 5 MG Oral TabletSYe6f3e718-bb99-48f1-ab94-b9f0af05fed616

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0006-5363-030000653630330 TABLET, FILM COATED in 1 BOTTLE (0006-5363-03) 2017-12-190000-00-00NoNoCurrent
0006-5363-060000653630690 TABLET, FILM COATED in 1 BOTTLE (0006-5363-06) 2017-12-190000-00-00NoNoCurrent
0006-5363-0700006536307500 TABLET, FILM COATED in 1 BOTTLE (0006-5363-07) 2017-12-190000-00-00NoNoCurrent
0006-5363-08000065363087 in 1 BOTTLEHistorical
0006-5363-09000065363092 BOTTLE in 1 CARTON (0006-5363-09) / 7 TABLET, FILM COATED in 1 BOTTLE (0006-5363-08) 2 bottle2017-12-190000-00-00NoNoCurrent
0006-5363-100000653631030 TABLET, FILM COATED in 1 BOTTLE (0006-5363-10) 2017-12-190000-00-00NoNoCurrent