FDA.reportPublic FDA data

Synjardy

Product NDC
0597-0300
11-digit product format
005970300
Labeler code
0597
Product ID
0597-0300_09b6e275-e784-41d8-a75d-74a22f3e2eca
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
empagliflozin, metformin hydrochloride
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Boehringer Ingelheim Pharmaceuticals, Inc.
Application
NDA208658
Marketing category
NDA
Marketing start
2016-12-10
Substance
EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE
Active strength
12.5; 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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Synjardy
Brand name suffix
XR
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
EMPAGLIFLOZIN12.5 mg/1
METFORMIN HYDROCHLORIDE1000 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiHDC1R2M35U, 786Z46389E
Rxcui1862685, 1862688, 1862691, 1862692, 1862695, 1862697, 1862700, 1862701

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
3a90349e-ff2e-41bd-a106-b368fbc1c1f8Product name120200612
5ab9c07d-ba46-4f19-88f9-a3bc7929fb86Product name120200214
1dc427fa-8c3b-4309-981e-ea1ff01326e5Product name120190731
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
a1e505bd-ab91-46e4-b7bc-a43a10199330Product name220170214
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
24acbc89-fd6a-458c-aa62-a3485b119bedProduct name120150323
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
0597-0300-20SynjardyXR14 in 1 BOTTLETABLET, EXTENDED RELEASE1417
0597-0300-20SynjardyXR1 in 1 CARTONTABLET, EXTENDED RELEASE117
0597-0300-45SynjardyXR60 in 1 BOTTLETABLET, EXTENDED RELEASE6017
0597-0300-93SynjardyXR180 in 1 BOTTLETABLET, EXTENDED RELEASE18017

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0597-0300-45EA - Each0597-0300c2e2f2e8-f5c5-43f4-94ca-7066df50000212017-04-05
0597-0300-93EA - Each0597-03004bdbcacc-4de9-49e9-b87e-76ed308267b912017-04-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0597-0300SYNJARDY XR (EMPAGLIFLOZIN, METFORMIN HYDROCHLORIDE) TABLET, EXTENDED RELEASE [BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.]14Current NDC, Legacy NDC, 4 package rows20250323_8006ba29-ee3a-f852-a9bb-c8ec9b41cf66.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1862685empagliflozin 10 MG / metFORMIN HCl 1000 MG 24HR Extended Release Oral TabletPSN8006ba29-ee3a-f852-a9bb-c8ec9b41cf6617
1862691empagliflozin 12.5 MG / metFORMIN HCl 1000 MG 24HR Extended Release Oral TabletPSN8006ba29-ee3a-f852-a9bb-c8ec9b41cf6617
1862695empagliflozin 25 MG / metFORMIN HCl 1000 MG 24HR Extended Release Oral TabletPSN8006ba29-ee3a-f852-a9bb-c8ec9b41cf6617
1862700empagliflozin 5 MG / metFORMIN HCl 1000 MG 24HR Extended Release Oral TabletPSN8006ba29-ee3a-f852-a9bb-c8ec9b41cf6617
1862688Synjardy XR 10 MG / 1000 MG 24HR Extended Release Oral TabletPSN8006ba29-ee3a-f852-a9bb-c8ec9b41cf6617
1862692Synjardy XR 12.5 MG / 1000 MG 24HR Extended Release Oral TabletPSN8006ba29-ee3a-f852-a9bb-c8ec9b41cf6617
1862697Synjardy XR 25 MG / 1000 MG 24HR Extended Release Oral TabletPSN8006ba29-ee3a-f852-a9bb-c8ec9b41cf6617
1862701Synjardy XR 5 MG / 1000 MG 24HR Extended Release Oral TabletPSN8006ba29-ee3a-f852-a9bb-c8ec9b41cf6617
186268824 HR empagliflozin 10 MG / metformin hydrochloride 1000 MG Extended Release Oral Tablet [Synjardy]SBD8006ba29-ee3a-f852-a9bb-c8ec9b41cf6617
186269224 HR empagliflozin 12.5 MG / metformin hydrochloride 1000 MG Extended Release Oral Tablet [Synjardy]SBD8006ba29-ee3a-f852-a9bb-c8ec9b41cf6617
186269724 HR empagliflozin 25 MG / metformin hydrochloride 1000 MG Extended Release Oral Tablet [Synjardy]SBD8006ba29-ee3a-f852-a9bb-c8ec9b41cf6617
186270124 HR empagliflozin 5 MG / metformin hydrochloride 1000 MG Extended Release Oral Tablet [Synjardy]SBD8006ba29-ee3a-f852-a9bb-c8ec9b41cf6617
186268524 HR empagliflozin 10 MG / metformin hydrochloride 1000 MG Extended Release Oral TabletSCD8006ba29-ee3a-f852-a9bb-c8ec9b41cf6617
186269124 HR empagliflozin 12.5 MG / metformin hydrochloride 1000 MG Extended Release Oral TabletSCD8006ba29-ee3a-f852-a9bb-c8ec9b41cf6617
186269524 HR empagliflozin 25 MG / metformin hydrochloride 1000 MG Extended Release Oral TabletSCD8006ba29-ee3a-f852-a9bb-c8ec9b41cf6617
186270024 HR empagliflozin 5 MG / metformin hydrochloride 1000 MG Extended Release Oral TabletSCD8006ba29-ee3a-f852-a9bb-c8ec9b41cf6617
1862685empagliflozin 10 MG / metformin HCl 1000 MG 24HR Extended Release Oral TabletSY8006ba29-ee3a-f852-a9bb-c8ec9b41cf6617
1862691empagliflozin 12.5 MG / metformin HCl 1000 MG 24HR Extended Release Oral TabletSY8006ba29-ee3a-f852-a9bb-c8ec9b41cf6617
1862695empagliflozin 25 MG / metformin HCl 1000 MG 24HR Extended Release Oral TabletSY8006ba29-ee3a-f852-a9bb-c8ec9b41cf6617
1862700empagliflozin 5 MG / metformin HCl 1000 MG 24HR Extended Release Oral TabletSY8006ba29-ee3a-f852-a9bb-c8ec9b41cf6617
1862688Synjardy XR 10 MG / 1000 MG 24HR Extended Release Oral TabletSY8006ba29-ee3a-f852-a9bb-c8ec9b41cf6617
1862692Synjardy XR 12.5 MG / 1000 MG 24HR Extended Release Oral TabletSY8006ba29-ee3a-f852-a9bb-c8ec9b41cf6617
1862697Synjardy XR 25 MG / 1000 MG 24HR Extended Release Oral TabletSY8006ba29-ee3a-f852-a9bb-c8ec9b41cf6617
1862701Synjardy XR 5 MG / 1000 MG 24HR Extended Release Oral TabletSY8006ba29-ee3a-f852-a9bb-c8ec9b41cf6617

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0597-0300-20005970300201 BOTTLE in 1 CARTON (0597-0300-20) / 14 TABLET, EXTENDED RELEASE in 1 BOTTLE1 bottle2016-12-100000-00-00YesNoCurrent
0597-0300-450059703004560 TABLET, EXTENDED RELEASE in 1 BOTTLE (0597-0300-45) 2016-12-100000-00-00NoNoCurrent
0597-0300-9300597030093180 TABLET, EXTENDED RELEASE in 1 BOTTLE (0597-0300-93) 2016-12-100000-00-00NoNoCurrent