FDA.reportPublic FDA data

DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE

Product NDC
72205-434
11-digit product format
722050434
Labeler code
72205
Product ID
72205-434_4f890458-be94-4baf-b606-83a097e1e23e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Novadoz Pharmaceuticals LLC
Application
ANDA211479
Marketing category
ANDA
Marketing start
2026-04-06
Substance
DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE
Active strength
5; 500 mg/1; mg/1
Pharmacologic classes
Biguanide [EPC], Biguanides [CS], 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 AND METFORMIN HYDROCHLORIDE
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DAPAGLIFLOZIN5 mg/1
METFORMIN HYDROCHLORIDE500 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii786Z46389E, 1ULL0QJ8UC
Rxcui1593058, 1593068, 1593070, 1593072

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6a29d87d-f465-752d-5fa9-bd728c608ca2Product name420251215
f6d21fb1-2c09-48ab-8d89-eeadf5a9698eProduct name120250724
a985afd1-89a8-bfab-0231-b59db1a3a9b5Product name720250515
25bfaa4d-02a1-402c-96ec-9bf6e625484cProduct name120250307
08b60e13-e5d0-74ca-b5a8-e6df9cb1dca0Product name220240829
16dbe107-66d5-47b3-57ed-0cba6a8dfcccProduct name620240215
08b3e508-8c7e-3b95-0275-113510642fc6Product name220220309
c30aab5e-c89f-4b59-83b1-99a940b63351Product name120200925
3a90349e-ff2e-41bd-a106-b368fbc1c1f8Product name120200612
5ab9c07d-ba46-4f19-88f9-a3bc7929fb86Product name120200214
1dc427fa-8c3b-4309-981e-ea1ff01326e5Product name120190731
85b4e38c-4488-4e48-919e-244e107d9bd9Product name220190731
ca3f036c-6c06-b829-b379-1a3a4097099cProduct name920180605
e1ede89f-54c8-428f-ae84-9e8a2deb67dbProduct name120180306
5ec207a9-fa56-4ff7-8fae-9a7d9a6bf52cProduct name220170824
bea938a6-c880-985b-d27b-b59b0d8b5a77Product name320170626
0600b0d3-c32a-40bb-8d87-3a2934cd8f2fProduct name120170616
e2382c7e-9e14-4196-aeff-98e2cfaf63cbProduct name120170224
988f737f-e7e9-4613-8558-824b1ab755f9Product name120161128
58b66776-50d5-434f-916f-958ccf131e0eProduct name120160713
3e9b6ece-066b-2ac3-28f7-5e13060e5934Product name220151109
2988466d-5fc4-4430-9cee-fc9132f02d2cProduct name120150910
85cbb42f-1a8d-f945-f85e-188e823b7f5bProduct name220150731
e740bf83-275a-4f0c-adf4-ec60ebd882b7Product name120150105
8d7b9e2e-c1f8-4f6e-a1f3-e4ce405be5f0Product name120141205
0d79b284-47e8-e90c-f249-892b9b251003Product name120140508
25391a6f-d1ba-6bff-d36e-050dc68ef0e6Product name120140508
2de6e143-c970-2061-1b77-61c3aa8f4026Product name120140508
2dee091b-3b8c-d27a-b1ba-fcb0d32e776aProduct name120140508
ce63c1f8-ba50-8a17-9290-94522d75daffProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72205-434-01DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE30 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE301
72205-434-02DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE500 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE5001

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72205-434-01EA - Each72205-434e3b6a175-ec74-4ac7-9a03-b1ceb933082a12026-05-22

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1593058dapagliflozin 10 MG / metFORMIN HCl 1000 MG 24HR Extended Release Oral TabletPSN4f890458-be94-4baf-b606-83a097e1e23e1
1593068dapagliflozin 10 MG / metFORMIN HCl 500 MG 24HR Extended Release Oral TabletPSN4f890458-be94-4baf-b606-83a097e1e23e1
1593070dapagliflozin 5 MG / metFORMIN HCl 1000 MG 24HR Extended Release Oral TabletPSN4f890458-be94-4baf-b606-83a097e1e23e1
1593072dapagliflozin 5 MG / metFORMIN HCl 500 MG 24HR Extended Release Oral TabletPSN4f890458-be94-4baf-b606-83a097e1e23e1
159305824 HR dapagliflozin 10 MG / metformin hydrochloride 1000 MG Extended Release Oral TabletSCD4f890458-be94-4baf-b606-83a097e1e23e1
159306824 HR dapagliflozin 10 MG / metformin hydrochloride 500 MG Extended Release Oral TabletSCD4f890458-be94-4baf-b606-83a097e1e23e1
159307024 HR dapagliflozin 5 MG / metformin hydrochloride 1000 MG Extended Release Oral TabletSCD4f890458-be94-4baf-b606-83a097e1e23e1
159307224 HR dapagliflozin 5 MG / metformin hydrochloride 500 MG Extended Release Oral TabletSCD4f890458-be94-4baf-b606-83a097e1e23e1
1593058dapagliflozin (as dapagliflozin propanediol) 10 MG / metformin hydrochloride 1000 MG 24 HR Extended Release Oral TabletSY4f890458-be94-4baf-b606-83a097e1e23e1
1593070dapagliflozin (as dapagliflozin propanediol) 5 MG / metformin hydrochloride 1000 MG 24 HR Extended Release Oral TabletSY4f890458-be94-4baf-b606-83a097e1e23e1
1593068dapagliflozin 10 MG / metformin HCl 500 MG 24HR Extended Release Oral TabletSY4f890458-be94-4baf-b606-83a097e1e23e1
1593072dapagliflozin 5 MG / metformin HCl 500 MG 24HR Extended Release Oral TabletSY4f890458-be94-4baf-b606-83a097e1e23e1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
72205-434-017220504340130 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (72205-434-01) 2026-04-09NoNoHistorical
72205-434-0272205043402500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (72205-434-02) 2026-04-09NoNoHistorical