FDA.reportPublic FDA data

XIGDUO

Product NDC
0310-6225
11-digit product format
003106225
Labeler code
0310
Product ID
0310-6225_a8717b28-9445-4292-9ac7-e979f378d9c8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
dapagliflozin and metformin hydrochloride
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
AstraZeneca Pharmaceuticals LP
Application
NDA205649
Marketing category
NDA
Marketing start
2014-10-29
Substance
DAPAGLIFLOZIN PROPANEDIOL; METFORMIN HYDROCHLORIDE
Active strength
2.5; 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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
XIGDUO
Brand name suffix
XR
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DAPAGLIFLOZIN PROPANEDIOL2.5 mg/1
METFORMIN HYDROCHLORIDE1000 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii786Z46389E, 887K2391VH
Rxcui1593058, 1593068, 1593070, 1593072, 1593775, 1593831, 1593833, 1593835, 1940496, 1940498

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
0310-6225-60XIGDUOXR60 in 1 BOTTLE, PLASTICTABLET, FILM COATED, EXTENDED RE6038
0310-6225-94XIGDUOXR14 in 1 BLISTER PACKTABLET, FILM COATED, EXTENDED RE1438
0310-6225-94XIGDUOXR1 in 1 CARTONTABLET, FILM COATED, EXTENDED RE138

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0310-6225-60EA - Each0310-6225d036711d-73ba-4043-be51-063dfbe6ed4a12018-02-20

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DAPAGLIFLOZIN PROPANEDIOLACTIVE INGREDIENT887K2391VHXIGDUO XR (DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [ASTRAZENECA PHARMACEUTICALS LP]1
METFORMIN HYDROCHLORIDEACTIVE INGREDIENT786Z46389EXIGDUO XR (DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [ASTRAZENECA PHARMACEUTICALS LP]1
dapagliflozinACTIVE MOIETY1ULL0QJ8UCXIGDUO XR (DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [ASTRAZENECA PHARMACEUTICALS LP]1
metforminACTIVE MOIETY9100L32L2NXIGDUO XR (DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [ASTRAZENECA PHARMACEUTICALS LP]1
anhydrous lactoseINACTIVE INGREDIENT3SY5LH9PMKXIGDUO XR (DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [ASTRAZENECA PHARMACEUTICALS LP]1
carboxymethylcellulose sodiumINACTIVE INGREDIENTK679OBS311XIGDUO XR (DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [ASTRAZENECA PHARMACEUTICALS LP]1
cellulose, microcrystallineINACTIVE INGREDIENTOP1R32D61UXIGDUO XR (DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [ASTRAZENECA PHARMACEUTICALS LP]1
crospovidoneINACTIVE INGREDIENT68401960MKXIGDUO XR (DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [ASTRAZENECA PHARMACEUTICALS LP]1
HYPROMELLOSE 2208 (100000 MPA.S)INACTIVE INGREDIENTVM7F0B23ZIXIGDUO XR (DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [ASTRAZENECA PHARMACEUTICALS LP]1
HYPROMELLOSE 2910 (5 MPA.S)INACTIVE INGREDIENTR75537T0T4XIGDUO XR (DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [ASTRAZENECA PHARMACEUTICALS LP]1
magnesium stearateINACTIVE INGREDIENT70097M6I30XIGDUO XR (DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [ASTRAZENECA PHARMACEUTICALS LP]1
silicon dioxideINACTIVE INGREDIENTETJ7Z6XBU4XIGDUO XR (DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [ASTRAZENECA PHARMACEUTICALS LP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0310-6225XIGDUO XR (DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [ASTRAZENECA PHARMACEUTICALS LP]38Current NDC, Legacy NDC, 3 package rows20250123_ac8a0f7b-9f69-4495-abbc-3a47cd75a859.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1593058dapagliflozin 10 MG / metFORMIN HCl 1000 MG 24HR Extended Release Oral TabletPSNac8a0f7b-9f69-4495-abbc-3a47cd75a85938
1593068dapagliflozin 10 MG / metFORMIN HCl 500 MG 24HR Extended Release Oral TabletPSNac8a0f7b-9f69-4495-abbc-3a47cd75a85938
1940496dapagliflozin 2.5 MG / metFORMIN HCl 1000 MG 24HR Extended Release Oral TabletPSNac8a0f7b-9f69-4495-abbc-3a47cd75a85938
1593070dapagliflozin 5 MG / metFORMIN HCl 1000 MG 24HR Extended Release Oral TabletPSNac8a0f7b-9f69-4495-abbc-3a47cd75a85938
1593072dapagliflozin 5 MG / metFORMIN HCl 500 MG 24HR Extended Release Oral TabletPSNac8a0f7b-9f69-4495-abbc-3a47cd75a85938
1593775Xigduo XR 10/1000 24HR Extended Release Oral TabletPSNac8a0f7b-9f69-4495-abbc-3a47cd75a85938
1593835Xigduo XR 10/500 24HR Extended Release Oral TabletPSNac8a0f7b-9f69-4495-abbc-3a47cd75a85938
1940498Xigduo XR 2.5/1000 24HR Extended Release Oral TabletPSNac8a0f7b-9f69-4495-abbc-3a47cd75a85938
1593833Xigduo XR 5/1000 24HR Extended Release Oral TabletPSNac8a0f7b-9f69-4495-abbc-3a47cd75a85938
1593831Xigduo XR 5/500 24HR Extended Release Oral TabletPSNac8a0f7b-9f69-4495-abbc-3a47cd75a85938
159377524 HR dapagliflozin 10 MG / metformin hydrochloride 1000 MG Extended Release Oral Tablet [Xigduo]SBDac8a0f7b-9f69-4495-abbc-3a47cd75a85938
159383524 HR dapagliflozin 10 MG / metformin hydrochloride 500 MG Extended Release Oral Tablet [Xigduo]SBDac8a0f7b-9f69-4495-abbc-3a47cd75a85938
194049824 HR dapagliflozin 2.5 MG / metformin hydrochloride 1000 MG Extended Release Oral Tablet [Xigduo]SBDac8a0f7b-9f69-4495-abbc-3a47cd75a85938
159383324 HR dapagliflozin 5 MG / metformin hydrochloride 1000 MG Extended Release Oral Tablet [Xigduo]SBDac8a0f7b-9f69-4495-abbc-3a47cd75a85938
159383124 HR dapagliflozin 5 MG / metformin hydrochloride 500 MG Extended Release Oral Tablet [Xigduo]SBDac8a0f7b-9f69-4495-abbc-3a47cd75a85938
159305824 HR dapagliflozin 10 MG / metformin hydrochloride 1000 MG Extended Release Oral TabletSCDac8a0f7b-9f69-4495-abbc-3a47cd75a85938
159306824 HR dapagliflozin 10 MG / metformin hydrochloride 500 MG Extended Release Oral TabletSCDac8a0f7b-9f69-4495-abbc-3a47cd75a85938
194049624 HR dapagliflozin 2.5 MG / metformin hydrochloride 1000 MG Extended Release Oral TabletSCDac8a0f7b-9f69-4495-abbc-3a47cd75a85938
159307024 HR dapagliflozin 5 MG / metformin hydrochloride 1000 MG Extended Release Oral TabletSCDac8a0f7b-9f69-4495-abbc-3a47cd75a85938
159307224 HR dapagliflozin 5 MG / metformin hydrochloride 500 MG Extended Release Oral TabletSCDac8a0f7b-9f69-4495-abbc-3a47cd75a85938
1593058dapagliflozin (as dapagliflozin propanediol) 10 MG / metformin hydrochloride 1000 MG 24 HR Extended Release Oral TabletSYac8a0f7b-9f69-4495-abbc-3a47cd75a85938
1593070dapagliflozin (as dapagliflozin propanediol) 5 MG / metformin hydrochloride 1000 MG 24 HR Extended Release Oral TabletSYac8a0f7b-9f69-4495-abbc-3a47cd75a85938
1593068dapagliflozin 10 MG / metformin HCl 500 MG 24HR Extended Release Oral TabletSYac8a0f7b-9f69-4495-abbc-3a47cd75a85938
1940496dapagliflozin 2.5 MG / metformin HCl 1000 MG 24HR Extended Release Oral TabletSYac8a0f7b-9f69-4495-abbc-3a47cd75a85938
1593072dapagliflozin 5 MG / metformin HCl 500 MG 24HR Extended Release Oral TabletSYac8a0f7b-9f69-4495-abbc-3a47cd75a85938
1593775Xigduo XR 10/1000 24HR Extended Release Oral TabletSYac8a0f7b-9f69-4495-abbc-3a47cd75a85938
1593835Xigduo XR 10/500 24HR Extended Release Oral TabletSYac8a0f7b-9f69-4495-abbc-3a47cd75a85938
1940498Xigduo XR 2.5/1000 24HR Extended Release Oral TabletSYac8a0f7b-9f69-4495-abbc-3a47cd75a85938
1593833Xigduo XR 5/1000 24HR Extended Release Oral TabletSYac8a0f7b-9f69-4495-abbc-3a47cd75a85938
1593831Xigduo XR 5/500 24HR Extended Release Oral TabletSYac8a0f7b-9f69-4495-abbc-3a47cd75a85938

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0310-6225-600031062256060 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0310-6225-60) 2018-01-150000-00-00NoNoCurrent
0310-6225-94003106225941 BLISTER PACK in 1 CARTON (0310-6225-94) > 14 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK1 blister pack2018-01-150000-00-00YesNoCurrent