DAPAGLIFLOZIN

Product NDC
63629-3253
11-digit product format
636293253
Labeler code
63629
Product ID
63629-3253_4ef8db0b-c28e-44ff-bf60-a9f8018c5861
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
DAPAGLIFLOZIN
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
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
63629-3253-1DAPAGLIFLOZIN30 in 1 BOTTLETABLET, FILM COATED30101

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-3253-1EA - Each63629-32535c0402f4-8915-4804-9c4b-c44510c4c3a512025-08-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-3253DAPAGLIFLOZIN TABLET, FILM COATED [BRYANT RANCH PREPACK]101Current NDC, 1 package rows20240820_979205ee-b0b8-4483-ae61-f283f750bb7f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1488569dapagliflozin 10 MG Oral TabletPSN979205ee-b0b8-4483-ae61-f283f750bb7f101
1488569dapagliflozin 10 MG Oral TabletSCD979205ee-b0b8-4483-ae61-f283f750bb7f101
1488569dapagliflozin 10 MG Oral TabletSY979205ee-b0b8-4483-ae61-f283f750bb7f101

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
63629-3253-16362932530130 TABLET, FILM COATED in 1 BOTTLE (63629-3253-1) 2024-01-24NoNoHistorical