FDA.reportPublic FDA data

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

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 Identifiers#

Field, Values table
FieldValues
UniiQFP0P1DV7Z
Rxcui665033, 665038, 665042, 2670447, 2670449, 2670451

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

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