ZITUVIO

Product NDC
70710-1241
11-digit product format
707101241
Labeler code
70710
Product ID
70710-1241_1686e1de-8172-444b-a267-ad3bc7ca69f1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sitagliptin
Dosage form
TABLET
Route
ORAL
Labeler
Zydus Pharmaceuticals (USA) Inc.
Application
NDA211566
Marketing category
NDA
Marketing start
2023-11-30
Substance
SITAGLIPTIN
Active strength
50 mg/1
Pharmacologic classes
Dipeptidyl Peptidase 4 Inhibitor [EPC], Dipeptidyl Peptidase 4 Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

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

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N211566-001ZITUVIOSITAGLIPTIN25MGTABLET / ORALRLD2023-10-18
N211566-002ZITUVIOSITAGLIPTIN50MGTABLET / ORALRLD2023-10-18
N211566-003ZITUVIOSITAGLIPTIN100MGTABLET / ORALRLD, RS2023-10-18

Orange Book patents#

Current patent rows page 1 of 1 · 3 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N211566-001109258712035-02-25Drug product2023-12-18
N211566-002109258712035-02-25Drug product2023-12-18
N211566-003109258712035-02-25Drug product2023-12-18

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.

Product history page 1 of 2 · 57 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N211566-001ZITUVIO25MGTABLET / ORALRLD2023-10-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02N211566-002ZITUVIO50MGTABLET / ORALRLD2023-10-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02N211566-003ZITUVIO100MGTABLET / ORALRLD, RS2023-10-18011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N211566-001ZITUVIO25MGTABLET / ORALRLD2023-10-1831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N211566-002ZITUVIO50MGTABLET / ORALRLD2023-10-1831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N211566-003ZITUVIO100MGTABLET / ORALRLD, RS2023-10-1831067a03dcf5…
2025-08-23 18:47 UTC2025-08N211566-001ZITUVIO25MGTABLET / ORALRLD2023-10-186a471c1ec25d…
2025-08-23 18:47 UTC2025-08N211566-002ZITUVIO50MGTABLET / ORALRLD2023-10-186a471c1ec25d…
2025-08-23 18:47 UTC2025-08N211566-003ZITUVIO100MGTABLET / ORALRLD, RS2023-10-186a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N211566-001ZITUVIO25MGTABLET / ORALRLD2023-10-18fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N211566-002ZITUVIO50MGTABLET / ORALRLD2023-10-18fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N211566-003ZITUVIO100MGTABLET / ORALRLD, RS2023-10-18fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N211566-001ZITUVIO25MGTABLET / ORALRLD2023-10-18b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N211566-002ZITUVIO50MGTABLET / ORALRLD2023-10-18b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N211566-003ZITUVIO100MGTABLET / ORALRLD, RS2023-10-18b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N211566-001ZITUVIO25MGTABLET / ORALRLD2023-10-1803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N211566-002ZITUVIO50MGTABLET / ORALRLD2023-10-1803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N211566-003ZITUVIO100MGTABLET / ORALRLD, RS2023-10-1803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N211566-001ZITUVIO25MGTABLET / ORALRLD2023-10-182680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N211566-002ZITUVIO50MGTABLET / ORALRLD2023-10-182680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N211566-003ZITUVIO100MGTABLET / ORALRLD, RS2023-10-182680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N211566-001ZITUVIO25MGTABLET / ORALRLD2023-10-185bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N211566-002ZITUVIO50MGTABLET / ORALRLD2023-10-185bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N211566-003ZITUVIO100MGTABLET / ORALRLD, RS2023-10-185bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N211566-001ZITUVIO25MGTABLET / ORALRLD2023-10-18d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N211566-002ZITUVIO50MGTABLET / ORALRLD2023-10-18d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N211566-003ZITUVIO100MGTABLET / ORALRLD, RS2023-10-18d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N211566-001ZITUVIO25MGTABLET / ORALRLD2023-10-18d06236e962d9…
2024-10-29 15:01 UTC2024-10N211566-002ZITUVIO50MGTABLET / ORALRLD2023-10-18d06236e962d9…
2024-10-29 15:01 UTC2024-10N211566-003ZITUVIO100MGTABLET / ORALRLD, RS2023-10-18d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N211566-001ZITUVIO25MGTABLET / ORALRLD2023-10-1879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N211566-002ZITUVIO50MGTABLET / ORALRLD2023-10-1879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N211566-003ZITUVIO100MGTABLET / ORALRLD, RS2023-10-1879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N211566-001ZITUVIO25MGTABLET / ORALRLD2023-10-18301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N211566-002ZITUVIO50MGTABLET / ORALRLD2023-10-18301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N211566-003ZITUVIO100MGTABLET / ORALRLD, RS2023-10-18301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N211566-001ZITUVIO25MGTABLET / ORALRLD2023-10-181e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N211566-002ZITUVIO50MGTABLET / ORALRLD2023-10-181e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N211566-003ZITUVIO100MGTABLET / ORALRLD, RS2023-10-181e350fbaab3a…
2024-05-31 18:47 UTC2024-05N211566-001ZITUVIO25MGTABLET / ORALRLD2023-10-188072bd15b7f6…

Observed Orange Book patent history#

Patent history page 1 of 2 · 51 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-02-19 14:30 UTC2026-02N211566-001109258712035-02-25Drug product2023-12-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02N211566-002109258712035-02-25Drug product2023-12-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02N211566-003109258712035-02-25Drug product2023-12-18011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N211566-001109258712035-02-25Drug product2023-12-1831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N211566-002109258712035-02-25Drug product2023-12-1831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N211566-003109258712035-02-25Drug product2023-12-1831067a03dcf5…
2025-08-23 18:47 UTC2025-08N211566-001109258712035-02-25Drug product2023-12-186a471c1ec25d…
2025-08-23 18:47 UTC2025-08N211566-002109258712035-02-25Drug product2023-12-186a471c1ec25d…
2025-08-23 18:47 UTC2025-08N211566-003109258712035-02-25Drug product2023-12-186a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N211566-001109258712035-02-25Drug product2023-12-18fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N211566-002109258712035-02-25Drug product2023-12-18fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N211566-003109258712035-02-25Drug product2023-12-18fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N211566-001109258712035-02-25Drug product2023-12-18b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N211566-002109258712035-02-25Drug product2023-12-18b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N211566-003109258712035-02-25Drug product2023-12-18b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N211566-001109258712035-02-25Drug product2023-12-1803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N211566-002109258712035-02-25Drug product2023-12-1803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N211566-003109258712035-02-25Drug product2023-12-1803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N211566-001109258712035-02-25Drug product2023-12-182680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N211566-002109258712035-02-25Drug product2023-12-182680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N211566-003109258712035-02-25Drug product2023-12-182680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N211566-001109258712035-02-25Drug product2023-12-185bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N211566-002109258712035-02-25Drug product2023-12-185bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N211566-003109258712035-02-25Drug product2023-12-185bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N211566-001109258712035-02-25Drug product2023-12-18d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N211566-002109258712035-02-25Drug product2023-12-18d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N211566-003109258712035-02-25Drug product2023-12-18d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N211566-001109258712035-02-25Drug product2023-12-18d06236e962d9…
2024-10-29 15:01 UTC2024-10N211566-002109258712035-02-25Drug product2023-12-18d06236e962d9…
2024-10-29 15:01 UTC2024-10N211566-003109258712035-02-25Drug product2023-12-18d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N211566-001109258712035-02-25Drug product2023-12-1879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N211566-002109258712035-02-25Drug product2023-12-1879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N211566-003109258712035-02-25Drug product2023-12-1879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N211566-001109258712035-02-25Drug product2023-12-18301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N211566-002109258712035-02-25Drug product2023-12-18301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N211566-003109258712035-02-25Drug product2023-12-18301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N211566-001109258712035-02-25Drug product2023-12-181e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N211566-002109258712035-02-25Drug product2023-12-181e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N211566-003109258712035-02-25Drug product2023-12-181e350fbaab3a…
2024-05-31 18:47 UTC2024-05N211566-001109258712035-02-25Drug product2023-12-188072bd15b7f6…

Additional Listing Data#

Finished product
Yes
Brand name base
ZITUVIO
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SITAGLIPTIN50 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
QFP0P1DV7ZInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 6 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
665033Internal RxNorm lookup
665038Internal RxNorm lookup
665042Internal RxNorm lookup
2670447Internal RxNorm lookup
2670449Internal RxNorm lookup
2670451Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
abfdea45-c0ca-41e3-a510-e89810bc9cfeAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
19a549d9-1cb9-4833-ba02-91db3dcb07baProduct name120251107
f6d21fb1-2c09-48ab-8d89-eeadf5a9698eProduct name120250724
ff2e6e82-af62-4b84-b1ca-09520f6c5a79Product name120250630
25bfaa4d-02a1-402c-96ec-9bf6e625484cProduct name120250307
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
fd232072-39c4-4416-9b66-265d18a7bd93Product name120180306
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
25391a6f-d1ba-6bff-d36e-050dc68ef0e6Product name120140508
2de6e143-c970-2061-1b77-61c3aa8f4026Product name120140508
9fa860f8-41a8-caa8-93ae-a5bdc7b15db7Product name120140508
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70710-1241-3ZITUVIO30 in 1 BOTTLETABLET307
70710-1241-9ZITUVIO90 in 1 BOTTLETABLET907

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70710-1241-3EA - Each70710-124122e1d999-1cb7-4c8e-8ef1-4b9895730e9512024-01-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70710-1241ZITUVIO (SITAGLIPTIN) TABLET [ZYDUS PHARMACEUTICALS (USA) INC.]7Current NDC, 2 package rows20250201_abfdea45-c0ca-41e3-a510-e89810bc9cfe.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ZITUVIOSITAGLIPTINZydus Pharmaceuticals (USA) Inc.abfdea45-c0ca-41e3-a510-e89810bc9cfe2025-01-31Warnings, Adverse reactionsExact identifier
application applno (NDA): 211566
application number: NDA211566
ndc (product): 70710-1241
ZITUVIOSITAGLIPTINZydus Lifesciences Limitedb2da9d77-154b-48f7-8793-3f4a24dfafc62025-01-31Warnings, Adverse reactionsExact identifier
application applno (NDA): 211566
application number: NDA211566
SitagliptinSITAGLIPTINZydus Pharmaceuticals (USA) Inc.6a970e80-b753-48fa-9fff-87e7a50449822025-01-31Warnings, Adverse reactionsExact identifier
application applno (NDA): 211566
application number: NDA211566
SitagliptinSITAGLIPTINZydus Lifesciences Limitede5ac97e8-3a0b-4750-8e3f-3374125707462025-01-31Warnings, Adverse reactionsExact identifier
application applno (NDA): 211566
application number: NDA211566

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
665033SITagliptin 100 MG Oral TabletPSNabfdea45-c0ca-41e3-a510-e89810bc9cfe7
665038SITagliptin 25 MG Oral TabletPSNabfdea45-c0ca-41e3-a510-e89810bc9cfe7
665042SITagliptin 50 MG Oral TabletPSNabfdea45-c0ca-41e3-a510-e89810bc9cfe7
2670447Zituvio 100 MG Oral TabletPSNabfdea45-c0ca-41e3-a510-e89810bc9cfe7
2670449Zituvio 25 MG Oral TabletPSNabfdea45-c0ca-41e3-a510-e89810bc9cfe7
2670451Zituvio 50 MG Oral TabletPSNabfdea45-c0ca-41e3-a510-e89810bc9cfe7
2670447sitagliptin 100 MG Oral Tablet [Zituvio]SBDabfdea45-c0ca-41e3-a510-e89810bc9cfe7
2670449sitagliptin 25 MG Oral Tablet [Zituvio]SBDabfdea45-c0ca-41e3-a510-e89810bc9cfe7
2670451sitagliptin 50 MG Oral Tablet [Zituvio]SBDabfdea45-c0ca-41e3-a510-e89810bc9cfe7
665033sitagliptin 100 MG Oral TabletSCDabfdea45-c0ca-41e3-a510-e89810bc9cfe7
665038sitagliptin 25 MG Oral TabletSCDabfdea45-c0ca-41e3-a510-e89810bc9cfe7
665042sitagliptin 50 MG Oral TabletSCDabfdea45-c0ca-41e3-a510-e89810bc9cfe7
2670447Zituvio 100 MG Oral TabletSYabfdea45-c0ca-41e3-a510-e89810bc9cfe7
2670449Zituvio 25 MG Oral TabletSYabfdea45-c0ca-41e3-a510-e89810bc9cfe7
2670451Zituvio 50 MG Oral TabletSYabfdea45-c0ca-41e3-a510-e89810bc9cfe7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70710-1241-37071012410330 TABLET in 1 BOTTLE (70710-1241-3) 30 tablet2023-11-30NoNoCurrent
70710-1241-97071012410990 TABLET in 1 BOTTLE (70710-1241-9) 90 tablet2023-11-30NoNoCurrent