FDA.reportPublic FDA data

Jardiance

Product NDC
0597-0152
Requested package NDC
0597-0152-70
11-digit product format
005970152
Labeler code
0597
Product ID
0597-0152_09daa78d-f417-436c-a29e-029c015ca6d6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Empagliflozin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Boehringer Ingelheim Pharmaceuticals, Inc.
Application
NDA204629
Marketing category
NDA
Marketing start
2014-08-01
Substance
EMPAGLIFLOZIN
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

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage0597-01520597-0152-70DDiscontinued by firm2026-07-31

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N204629-001JARDIANCEEMPAGLIFLOZIN10MGTABLET / ORALRLD2014-08-01
N204629-002JARDIANCEEMPAGLIFLOZIN25MGTABLET / ORALRLD, RS2014-08-01

Orange Book patents#

Current patent rows page 1 of 1 · 64 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N204629-00177139382027-04-15Drug substance, Drug product2014-08-15
N204629-0017713938*PED2027-10-15Pediatric extension
N204629-00175794492028-08-01Drug substance2014-08-15
N204629-0017579449*PED2029-02-01Pediatric extension
N204629-00185519572029-10-14U-16512016-03-14
N204629-001121151792030-02-11U-40232024-11-12
N204629-0018551957*PED2030-04-14Pediatric extension
N204629-00112115179*PED2030-08-11Pediatric extension
N204629-001125278102033-04-22U-44032026-02-10
N204629-00112527810*PED2033-10-22Pediatric extension
N204629-001102586372034-04-03U-22902019-04-30
N204629-001110903232034-04-03U-31912021-08-20
N204629-001116665902034-04-03U-36912023-10-03
N204629-001118132752034-04-03U-37592023-12-13
N204629-001118132752034-04-03U-37602023-12-13
N204629-001118331662034-04-03U-37762024-01-03
N204629-001118331662034-04-03U-37772024-01-03
N204629-001122631532034-04-03U-41712025-04-29
N204629-001124271622034-04-03U-42872025-10-17
N204629-001124339062034-04-03U-42932025-10-30
N204629-001124339062034-04-03U-42942025-10-30
N204629-001124339062034-04-03U-42952025-10-30
N204629-001124339062034-04-03U-42962025-10-30
N204629-001124339062034-04-03U-43042025-10-30
N204629-00199499972034-05-17U-22922018-05-15
N204629-00199499972034-05-17U-31992018-05-15
N204629-00199499972034-05-17U-33252018-05-15
N204629-00199499982034-06-11U-22902018-05-15
N204629-00110258637*PED2034-10-03Pediatric extension
N204629-00111090323*PED2034-10-03Pediatric extension
N204629-00111813275*PED2034-10-03Pediatric extension
N204629-00111833166*PED2034-10-03Pediatric extension
N204629-00112433906*PED2034-10-03Pediatric extension
N204629-0019949997*PED2034-11-17Pediatric extension
N204629-0019949998*PED2034-12-11Pediatric extension
N204629-00277139382027-04-15Drug substance, Drug product2014-08-15
N204629-0027713938*PED2027-10-15Pediatric extension
N204629-00275794492028-08-01Drug substance2014-08-15
N204629-0027579449*PED2029-02-01Pediatric extension
N204629-00285519572029-10-14U-16512016-03-14
N204629-002121151792030-02-11U-40232024-11-12
N204629-0028551957*PED2030-04-14Pediatric extension
N204629-00212115179*PED2030-08-11Pediatric extension
N204629-002125278102033-04-22U-44032026-02-10
N204629-00212527810*PED2033-10-22Pediatric extension
N204629-002102586372034-04-03U-22902019-04-30
N204629-002110903232034-04-03U-31912021-08-20
N204629-002118331662034-04-03U-37762024-01-03
N204629-002118331662034-04-03U-37772024-01-03
N204629-002122631532034-04-03U-41712025-04-29
N204629-002124271622034-04-03U-42872025-10-17
N204629-002124339062034-04-03U-42932025-10-30
N204629-002124339062034-04-03U-42942025-10-30
N204629-002124339062034-04-03U-42952025-10-30
N204629-002124339062034-04-03U-42962025-10-30
N204629-002124339062034-04-03U-43042025-10-30
N204629-00299499972034-05-17U-22922018-05-15
N204629-00299499982034-06-11U-22902018-05-15
N204629-00210258637*PED2034-10-03Pediatric extension
N204629-00211090323*PED2034-10-03Pediatric extension
N204629-00211833166*PED2034-10-03Pediatric extension
N204629-00212433906*PED2034-10-03Pediatric extension
N204629-0029949997*PED2034-11-17Pediatric extension
N204629-0029949998*PED2034-12-11Pediatric extension

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 5 matching rows.

Application-product, Exclusivity code, Expiration table
Application-productExclusivity codeExpiration
N204629-001NPP2026-06-20
N204629-001I-9222026-09-21
N204629-001PED2026-12-20
N204629-002NPP2026-06-20
N204629-002PED2026-12-20

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
2026-08-01 22:54:322026-06N204629-001JARDIANCE10MGTABLET / ORALRLD2014-08-01a50c72e98297…
2026-08-01 22:54:322026-06N204629-002JARDIANCE25MGTABLET / ORALRLD, RS2014-08-01a50c72e98297…

Observed Orange Book patent history#

Patent history page 1 of 2 · 64 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-08-01 22:54:322026-06N204629-00177139382027-04-15Drug substance, Drug product2014-08-15a50c72e98297…
2026-08-01 22:54:322026-06N204629-0017713938*PED2027-10-15Pediatric extensiona50c72e98297…
2026-08-01 22:54:322026-06N204629-00175794492028-08-01Drug substance2014-08-15a50c72e98297…
2026-08-01 22:54:322026-06N204629-0017579449*PED2029-02-01Pediatric extensiona50c72e98297…
2026-08-01 22:54:322026-06N204629-00185519572029-10-14U-16512016-03-14a50c72e98297…
2026-08-01 22:54:322026-06N204629-001121151792030-02-11U-40232024-11-12a50c72e98297…
2026-08-01 22:54:322026-06N204629-0018551957*PED2030-04-14Pediatric extensiona50c72e98297…
2026-08-01 22:54:322026-06N204629-00112115179*PED2030-08-11Pediatric extensiona50c72e98297…
2026-08-01 22:54:322026-06N204629-001125278102033-04-22U-44032026-02-10a50c72e98297…
2026-08-01 22:54:322026-06N204629-00112527810*PED2033-10-22Pediatric extensiona50c72e98297…
2026-08-01 22:54:322026-06N204629-001102586372034-04-03U-22902019-04-30a50c72e98297…
2026-08-01 22:54:322026-06N204629-001110903232034-04-03U-31912021-08-20a50c72e98297…
2026-08-01 22:54:322026-06N204629-001116665902034-04-03U-36912023-10-03a50c72e98297…
2026-08-01 22:54:322026-06N204629-001118132752034-04-03U-37592023-12-13a50c72e98297…
2026-08-01 22:54:322026-06N204629-001118132752034-04-03U-37602023-12-13a50c72e98297…
2026-08-01 22:54:322026-06N204629-001118331662034-04-03U-37762024-01-03a50c72e98297…
2026-08-01 22:54:322026-06N204629-001118331662034-04-03U-37772024-01-03a50c72e98297…
2026-08-01 22:54:322026-06N204629-001122631532034-04-03U-41712025-04-29a50c72e98297…
2026-08-01 22:54:322026-06N204629-001124271622034-04-03U-42872025-10-17a50c72e98297…
2026-08-01 22:54:322026-06N204629-001124339062034-04-03U-43042025-10-30a50c72e98297…
2026-08-01 22:54:322026-06N204629-001124339062034-04-03U-42932025-10-30a50c72e98297…
2026-08-01 22:54:322026-06N204629-001124339062034-04-03U-42942025-10-30a50c72e98297…
2026-08-01 22:54:322026-06N204629-001124339062034-04-03U-42952025-10-30a50c72e98297…
2026-08-01 22:54:322026-06N204629-001124339062034-04-03U-42962025-10-30a50c72e98297…
2026-08-01 22:54:322026-06N204629-00199499972034-05-17U-22922018-05-15a50c72e98297…
2026-08-01 22:54:322026-06N204629-00199499972034-05-17U-33252018-05-15a50c72e98297…
2026-08-01 22:54:322026-06N204629-00199499972034-05-17U-31992018-05-15a50c72e98297…
2026-08-01 22:54:322026-06N204629-00199499982034-06-11U-22902018-05-15a50c72e98297…
2026-08-01 22:54:322026-06N204629-00110258637*PED2034-10-03Pediatric extensiona50c72e98297…
2026-08-01 22:54:322026-06N204629-00111090323*PED2034-10-03Pediatric extensiona50c72e98297…
2026-08-01 22:54:322026-06N204629-00111813275*PED2034-10-03Pediatric extensiona50c72e98297…
2026-08-01 22:54:322026-06N204629-00111833166*PED2034-10-03Pediatric extensiona50c72e98297…
2026-08-01 22:54:322026-06N204629-00112433906*PED2034-10-03Pediatric extensiona50c72e98297…
2026-08-01 22:54:322026-06N204629-0019949997*PED2034-11-17Pediatric extensiona50c72e98297…
2026-08-01 22:54:322026-06N204629-0019949998*PED2034-12-11Pediatric extensiona50c72e98297…
2026-08-01 22:54:322026-06N204629-00277139382027-04-15Drug substance, Drug product2014-08-15a50c72e98297…
2026-08-01 22:54:322026-06N204629-0027713938*PED2027-10-15Pediatric extensiona50c72e98297…
2026-08-01 22:54:322026-06N204629-00275794492028-08-01Drug substance2014-08-15a50c72e98297…
2026-08-01 22:54:322026-06N204629-0027579449*PED2029-02-01Pediatric extensiona50c72e98297…
2026-08-01 22:54:322026-06N204629-00285519572029-10-14U-16512016-03-14a50c72e98297…

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2026-08-01 22:54:322026-06N204629-001NPP2026-06-20a50c72e98297…
2026-08-01 22:54:322026-06N204629-001I-9222026-09-21a50c72e98297…
2026-08-01 22:54:322026-06N204629-001PED2026-12-20a50c72e98297…
2026-08-01 22:54:322026-06N204629-002NPP2026-06-20a50c72e98297…
2026-08-01 22:54:322026-06N204629-002PED2026-12-20a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 8 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
JardianceEMPAGLIFLOZINAphena Pharma Solutions - Tennessee, LLC334f1b3d-5670-6685-e063-6294a90a7e472026-06-17Warnings, Adverse reactionsExact identifier
application applno (NDA): 204629
application number: NDA204629
JardianceEMPAGLIFLOZINCardinal Health 107, LLC5777b8a8-ada6-4950-8548-43a1de11f0752026-02-17Warnings, Adverse reactionsExact identifier
application applno (NDA): 204629
application number: NDA204629
JardianceEMPAGLIFLOZINBoehringer Ingelheim Pharmaceuticals, Inc.faf3dd6a-9cd0-39c2-0d2e-232cb3f675652026-01-30Warnings, Adverse reactionsExact identifier
application applno (NDA): 204629
application number: NDA204629
ndc (package): 0597-0152-70
ndc (product): 0597-0152
ndc11 (package): 00597015270
JardianceEMPAGLIFLOZINAphena Pharma Solutions - Tennessee, LLC8b6261f6-4bdc-462e-8af1-4064664c62f32025-10-27Warnings, Adverse reactionsExact identifier
application applno (NDA): 204629
application number: NDA204629
JardianceEMPAGLIFLOZINA-S Medication Solutionsa77214ca-572e-485e-aae9-f7950187e5fb2023-08-08Warnings, Adverse reactionsExact identifier
application applno (NDA): 204629
application number: NDA204629
JARDIANCEEMPAGLIFLOZINA-S Medication Solutions942a82a4-cbbd-4e44-9965-8d03f767912b2023-07-24Warnings, Adverse reactionsExact identifier
application applno (NDA): 204629
application number: NDA204629
JARDIANCEEMPAGLIFLOZINA-S Medication Solutions1782b947-4a72-4feb-a488-1469d9af82bd2023-05-03Warnings, Adverse reactionsExact identifier
application applno (NDA): 204629
application number: NDA204629
JARDIANCEEMPAGLIFLOZINA-S Medication Solutionsf2b41c77-0abb-40ee-8578-86a748d0e19e2023-05-03Warnings, Adverse reactionsExact identifier
application applno (NDA): 204629
application number: NDA204629

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
EMPAGLIFLOZIN10 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
HDC1R2M35UInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1545658Internal RxNorm lookup
1545664Internal RxNorm lookup
1545666Internal RxNorm lookup
1545668Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
faf3dd6a-9cd0-39c2-0d2e-232cb3f67565Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
3a90349e-ff2e-41bd-a106-b368fbc1c1f8Product name120200612
e2382c7e-9e14-4196-aeff-98e2cfaf63cbProduct name120170224
a1e505bd-ab91-46e4-b7bc-a43a10199330Product name220170214
2988466d-5fc4-4430-9cee-fc9132f02d2cProduct name120150910
24acbc89-fd6a-458c-aa62-a3485b119bedProduct name120150323

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0597-0152-07Jardiance7 in 1 BOTTLETABLET, FILM COATED731
0597-0152-07Jardiance1 in 1 CARTONTABLET, FILM COATED131
0597-0152-30Jardiance30 in 1 BOTTLETABLET, FILM COATED3031
0597-0152-37Jardiance1 in 1 BLISTER PACKTABLET, FILM COATED131
0597-0152-37Jardiance30 in 1 CARTONTABLET, FILM COATED3031
0597-0152-70Jardiance7 in 1 CARTONTABLET, FILM COATED731
0597-0152-70Jardiance1 in 1 BLISTER PACKTABLET, FILM COATED131
0597-0152-90Jardiance90 in 1 BOTTLETABLET, FILM COATED9031

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0597-0152-07EA - Each0597-015221a247ea-12da-494b-be59-8dfc1ba136ad12022-06-06
0597-0152-30EA - Each0597-015234ba6f63-aef1-4cbe-8915-4f6a394e958012014-09-03
0597-0152-37EA - Each0597-015242255d9c-5c76-4039-ab38-7705119f54e212015-10-02
0597-0152-90EA - Each0597-015272d8dab7-3bad-4b95-b22b-c8d5edb2073c12014-09-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
empagliflozinACTIVE INGREDIENTHDC1R2M35UJARDIANCE (EMPAGLIFLOZIN) TABLET, FILM COATED [BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.]2
empagliflozinACTIVE MOIETYHDC1R2M35UJARDIANCE (EMPAGLIFLOZIN) TABLET, FILM COATED [BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0597-0152JARDIANCE (EMPAGLIFLOZIN) TABLET, FILM COATED [BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.]29Current NDC, Legacy NDC, 8 package rows20250410_faf3dd6a-9cd0-39c2-0d2e-232cb3f67565.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1545658empagliflozin 10 MG Oral TabletPSNfaf3dd6a-9cd0-39c2-0d2e-232cb3f6756531
1545666empagliflozin 25 MG Oral TabletPSNfaf3dd6a-9cd0-39c2-0d2e-232cb3f6756531
1545664Jardiance 10 MG Oral TabletPSNfaf3dd6a-9cd0-39c2-0d2e-232cb3f6756531
1545668Jardiance 25 MG Oral TabletPSNfaf3dd6a-9cd0-39c2-0d2e-232cb3f6756531
1545664empagliflozin 10 MG Oral Tablet [Jardiance]SBDfaf3dd6a-9cd0-39c2-0d2e-232cb3f6756531
1545668empagliflozin 25 MG Oral Tablet [Jardiance]SBDfaf3dd6a-9cd0-39c2-0d2e-232cb3f6756531
1545658empagliflozin 10 MG Oral TabletSCDfaf3dd6a-9cd0-39c2-0d2e-232cb3f6756531
1545666empagliflozin 25 MG Oral TabletSCDfaf3dd6a-9cd0-39c2-0d2e-232cb3f6756531
1545664Jardiance 10 MG Oral TabletSYfaf3dd6a-9cd0-39c2-0d2e-232cb3f6756531
1545668Jardiance 25 MG Oral TabletSYfaf3dd6a-9cd0-39c2-0d2e-232cb3f6756531
1545658empagliflozin 10 MG Oral TabletPSN5777b8a8-ada6-4950-8548-43a1de11f07513
1545666empagliflozin 25 MG Oral TabletPSN5777b8a8-ada6-4950-8548-43a1de11f07513
1545664Jardiance 10 MG Oral TabletPSN5777b8a8-ada6-4950-8548-43a1de11f07513
1545668Jardiance 25 MG Oral TabletPSN5777b8a8-ada6-4950-8548-43a1de11f07513
1545664empagliflozin 10 MG Oral Tablet [Jardiance]SBD5777b8a8-ada6-4950-8548-43a1de11f07513
1545668empagliflozin 25 MG Oral Tablet [Jardiance]SBD5777b8a8-ada6-4950-8548-43a1de11f07513
1545658empagliflozin 10 MG Oral TabletSCD5777b8a8-ada6-4950-8548-43a1de11f07513
1545666empagliflozin 25 MG Oral TabletSCD5777b8a8-ada6-4950-8548-43a1de11f07513
1545664Jardiance 10 MG Oral TabletSY5777b8a8-ada6-4950-8548-43a1de11f07513
1545668Jardiance 25 MG Oral TabletSY5777b8a8-ada6-4950-8548-43a1de11f07513
1545658empagliflozin 10 MG Oral TabletPSN942a82a4-cbbd-4e44-9965-8d03f767912b9
1545664Jardiance 10 MG Oral TabletPSN942a82a4-cbbd-4e44-9965-8d03f767912b9
1545664empagliflozin 10 MG Oral Tablet [Jardiance]SBD942a82a4-cbbd-4e44-9965-8d03f767912b9
1545658empagliflozin 10 MG Oral TabletSCD942a82a4-cbbd-4e44-9965-8d03f767912b9
1545664Jardiance 10 MG Oral TabletSY942a82a4-cbbd-4e44-9965-8d03f767912b9
1545658empagliflozin 10 MG Oral TabletPSN334f1b3d-5670-6685-e063-6294a90a7e471
1545658empagliflozin 10 MG Oral TabletPSN1782b947-4a72-4feb-a488-1469d9af82bd1
1545664Jardiance 10 MG Oral TabletPSN334f1b3d-5670-6685-e063-6294a90a7e471
1545664Jardiance 10 MG Oral TabletPSN1782b947-4a72-4feb-a488-1469d9af82bd1
1545664empagliflozin 10 MG Oral Tablet [Jardiance]SBD1782b947-4a72-4feb-a488-1469d9af82bd1
1545664empagliflozin 10 MG Oral Tablet [Jardiance]SBD334f1b3d-5670-6685-e063-6294a90a7e471
1545658empagliflozin 10 MG Oral TabletSCD334f1b3d-5670-6685-e063-6294a90a7e471
1545658empagliflozin 10 MG Oral TabletSCD1782b947-4a72-4feb-a488-1469d9af82bd1
1545664Jardiance 10 MG Oral TabletSY334f1b3d-5670-6685-e063-6294a90a7e471
1545664Jardiance 10 MG Oral TabletSY1782b947-4a72-4feb-a488-1469d9af82bd1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0597-0152-70005970152707 BLISTER PACK in 1 CARTON (0597-0152-70) > 1 TABLET, FILM COATED in 1 BLISTER PACK7 blister pack2014-08-010000-00-00NoNoCurrent