DAPAGLIFLOZIN

Product NDC
66993-457
11-digit product format
669930457
Labeler code
66993
Product ID
66993-457_4cdea416-6da9-411e-aa5a-ba78fc388844
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
DAPAGLIFLOZIN
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Prasco Laboratories
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
DAPAGLIFLOZIN
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DAPAGLIFLOZIN PROPANEDIOL10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii887K2391VH
Rxcui1488569, 1488574

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
66993-457-30DAPAGLIFLOZIN30 in 1 BOTTLE, PLASTICTABLET, FILM COATED309

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
66993-457-30EA - Each66993-4579e8ea173-8990-4ad8-8a54-1a11f868ac7b12024-02-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66993-457DAPAGLIFLOZIN TABLET, FILM COATED [PRASCO, LLC]6Current NDC, 1 package rows20241031_3aba33aa-f8c6-4b10-85c8-dfa14578d07c.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
1488569dapagliflozin 10 MG Oral TabletPSN3aba33aa-f8c6-4b10-85c8-dfa14578d07c9
1488574dapagliflozin 5 MG Oral TabletPSN3aba33aa-f8c6-4b10-85c8-dfa14578d07c9
1488569dapagliflozin 10 MG Oral TabletSCD3aba33aa-f8c6-4b10-85c8-dfa14578d07c9
1488574dapagliflozin 5 MG Oral TabletSCD3aba33aa-f8c6-4b10-85c8-dfa14578d07c9
1488569dapagliflozin 10 MG Oral TabletSY3aba33aa-f8c6-4b10-85c8-dfa14578d07c9
1488574dapagliflozin 5 MG Oral TabletSY3aba33aa-f8c6-4b10-85c8-dfa14578d07c9
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
66993-457-306699304573030 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (66993-457-30) 2024-01-03NoNoHistorical