DAPAGLIFLOZIN

Product NDC
50090-7057
11-digit product format
500907057
Labeler code
50090
Product ID
50090-7057_593bc861-fc6b-408d-8a45-b08745301f02
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
DAPAGLIFLOZIN
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
NDA202293
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2024-01-03
Substance
DAPAGLIFLOZIN PROPANEDIOL
Active strength
10 mg/1
Pharmacologic classes
Sodium-Glucose Cotransporter 2 Inhibitor [EPC], Sodium-Glucose Transporter 2 Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DAPAGLIFLOZIN PROPANEDIOL10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii887K2391VH
Rxcui1488569

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c30aab5e-c89f-4b59-83b1-99a940b63351Product name120200925
1dc427fa-8c3b-4309-981e-ea1ff01326e5Product name120190731
85b4e38c-4488-4e48-919e-244e107d9bd9Product name220190731
5ec207a9-fa56-4ff7-8fae-9a7d9a6bf52cProduct name220170824

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-7057-0DAPAGLIFLOZIN30 in 1 BOTTLE, PLASTICTABLET, FILM COATED304

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-7057-0EA - Each50090-70576d2adcbd-ca2b-45c7-9c16-e4ff476d97f612024-02-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-7057DAPAGLIFLOZIN TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]4Current NDC, 1 package rows20240629_87521963-0d2a-4a2a-89c6-d50e8582419e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1488569dapagliflozin 10 MG Oral TabletPSN87521963-0d2a-4a2a-89c6-d50e8582419e4
1488569dapagliflozin 10 MG Oral TabletSCD87521963-0d2a-4a2a-89c6-d50e8582419e4
1488569dapagliflozin 10 MG Oral TabletSY87521963-0d2a-4a2a-89c6-d50e8582419e4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
50090-7057-05009070570030 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50090-7057-0) 2024-01-16NoNoCurrent