FDA.reportPublic FDA data

Dapagliflozin and Metformin Hydrochloride

Product NDC
33342-409
11-digit product format
333420409
Labeler code
33342
Product ID
33342-409_237ce7d1-f375-4c14-971d-a682fdccd6bf
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dapagliflozin and Metformin Hydrochloride
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Macleods Pharmaceuticals Limited
Application
ANDA211559
Marketing category
ANDA
Marketing start
2026-04-06
Substance
DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE
Active strength
10; 1000 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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A211559-001DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDEDAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE5MG;500MGTABLET, EXTENDED RELEASE / ORALAB2026-04-06
A211559-002DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDEDAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE5MG;1GMTABLET, EXTENDED RELEASE / ORALAB2026-04-06
A211559-003DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDEDAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE10MG;500MGTABLET, EXTENDED RELEASE / ORALAB2026-04-06
A211559-004DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDEDAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE10MG;1GMTABLET, EXTENDED RELEASE / ORALAB2026-04-06

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-productTE code
A211559-001AB
A211559-002AB
A211559-003AB
A211559-004AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A211559-001DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE5MG;500MGTABLET, EXTENDED RELEASE / ORALAB2026-04-0684e616aacf4f…
2026-09-14 22:38:342026-08A211559-002DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE5MG;1GMTABLET, EXTENDED RELEASE / ORALAB2026-04-0684e616aacf4f…
2026-09-14 22:38:342026-08A211559-003DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE10MG;500MGTABLET, EXTENDED RELEASE / ORALAB2026-04-0684e616aacf4f…
2026-09-14 22:38:342026-08A211559-004DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE10MG;1GMTABLET, EXTENDED RELEASE / ORALAB2026-04-0684e616aacf4f…
2026-08-18 06:07:402026-07A211559-001DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE5MG;500MGTABLET, EXTENDED RELEASE / ORALAB2026-04-06caaa826d4ba7…
2026-08-18 06:07:402026-07A211559-002DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE5MG;1GMTABLET, EXTENDED RELEASE / ORALAB2026-04-06caaa826d4ba7…
2026-08-18 06:07:402026-07A211559-003DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE10MG;500MGTABLET, EXTENDED RELEASE / ORALAB2026-04-06caaa826d4ba7…
2026-08-18 06:07:402026-07A211559-004DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE10MG;1GMTABLET, EXTENDED RELEASE / ORALAB2026-04-06caaa826d4ba7…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A211559-001DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE5MG;500MGTABLET, EXTENDED RELEASE / ORALAB2026-04-06a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A211559-002DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE5MG;1GMTABLET, EXTENDED RELEASE / ORALAB2026-04-06a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A211559-003DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE10MG;500MGTABLET, EXTENDED RELEASE / ORALAB2026-04-06a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A211559-004DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE10MG;1GMTABLET, EXTENDED RELEASE / ORALAB2026-04-06a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A211559-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A211559-002AB184e616aacf4f…
2026-09-14 22:38:342026-08A211559-003AB184e616aacf4f…
2026-09-14 22:38:342026-08A211559-004AB184e616aacf4f…
2026-08-18 06:07:402026-07A211559-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A211559-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A211559-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A211559-004AB1caaa826d4ba7…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A211559-001AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A211559-002AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A211559-003AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A211559-004AB1a50c72e98297…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
Dapagliflozin and Metformin Hydrochloride
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DAPAGLIFLOZIN10 mg/1
METFORMIN HYDROCHLORIDE1000 mg/1

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
33342-409-06Dapagliflozin and Metformin Hydrochloride3 in 1 CARTONTABLET, EXTENDED RELEASE31
33342-409-07Dapagliflozin and Metformin Hydrochloride30 in 1 BOTTLETABLET, EXTENDED RELEASE301
33342-409-09Dapagliflozin and Metformin Hydrochloride60 in 1 BOTTLETABLET, EXTENDED RELEASE601
33342-409-10Dapagliflozin and Metformin Hydrochloride90 in 1 BOTTLETABLET, EXTENDED RELEASE901
33342-409-15Dapagliflozin and Metformin Hydrochloride500 in 1 BOTTLETABLET, EXTENDED RELEASE5001
33342-409-66Dapagliflozin and Metformin Hydrochloride10 in 1 BLISTER PACKTABLET, EXTENDED RELEASE101

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
33342-409-07EA - Each33342-4094839cec7-f605-47be-8859-3d7fec47529a12026-05-22

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1593058dapagliflozin 10 MG / metFORMIN HCl 1000 MG 24HR Extended Release Oral TabletPSN7d575ca8-9c1f-469d-a341-34daf2f036dd1
1593068dapagliflozin 10 MG / metFORMIN HCl 500 MG 24HR Extended Release Oral TabletPSN7d575ca8-9c1f-469d-a341-34daf2f036dd1
1593070dapagliflozin 5 MG / metFORMIN HCl 1000 MG 24HR Extended Release Oral TabletPSN7d575ca8-9c1f-469d-a341-34daf2f036dd1
1593072dapagliflozin 5 MG / metFORMIN HCl 500 MG 24HR Extended Release Oral TabletPSN7d575ca8-9c1f-469d-a341-34daf2f036dd1
159305824 HR dapagliflozin 10 MG / metformin hydrochloride 1000 MG Extended Release Oral TabletSCD7d575ca8-9c1f-469d-a341-34daf2f036dd1
159306824 HR dapagliflozin 10 MG / metformin hydrochloride 500 MG Extended Release Oral TabletSCD7d575ca8-9c1f-469d-a341-34daf2f036dd1
159307024 HR dapagliflozin 5 MG / metformin hydrochloride 1000 MG Extended Release Oral TabletSCD7d575ca8-9c1f-469d-a341-34daf2f036dd1
159307224 HR dapagliflozin 5 MG / metformin hydrochloride 500 MG Extended Release Oral TabletSCD7d575ca8-9c1f-469d-a341-34daf2f036dd1
1593058dapagliflozin (as dapagliflozin propanediol) 10 MG / metformin hydrochloride 1000 MG 24 HR Extended Release Oral TabletSY7d575ca8-9c1f-469d-a341-34daf2f036dd1
1593070dapagliflozin (as dapagliflozin propanediol) 5 MG / metformin hydrochloride 1000 MG 24 HR Extended Release Oral TabletSY7d575ca8-9c1f-469d-a341-34daf2f036dd1
1593068dapagliflozin 10 MG / metformin HCl 500 MG 24HR Extended Release Oral TabletSY7d575ca8-9c1f-469d-a341-34daf2f036dd1
1593072dapagliflozin 5 MG / metformin HCl 500 MG 24HR Extended Release Oral TabletSY7d575ca8-9c1f-469d-a341-34daf2f036dd1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
33342-409-06333420409063 BLISTER PACK in 1 CARTON (33342-409-06) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (33342-409-66) 3 blister pack2026-04-06NoNoCurrent
33342-409-073334204090730 TABLET, EXTENDED RELEASE in 1 BOTTLE (33342-409-07) 2026-04-06NoNoCurrent
33342-409-093334204090960 TABLET, EXTENDED RELEASE in 1 BOTTLE (33342-409-09) 2026-04-06NoNoCurrent
33342-409-103334204091090 TABLET, EXTENDED RELEASE in 1 BOTTLE (33342-409-10) 2026-04-06NoNoCurrent
33342-409-1533342040915500 TABLET, EXTENDED RELEASE in 1 BOTTLE (33342-409-15) 2026-04-06NoNoCurrent
33342-409-663334204096610 in 1 BLISTER PACKHistorical