Sitagliptin Phosphate

Product NDC
0781-5766
11-digit product format
007815766
Labeler code
0781
Product ID
0781-5766_dd07ef38-4a9b-46f4-90ed-dd520cc1d75e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sitagliptin Phosphate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Sandoz Inc
Application
ANDA202387
Marketing category
ANDA
Marketing start
2026-01-14
Substance
SITAGLIPTIN PHOSPHATE
Active strength
25 mg/1
Pharmacologic classes
Dipeptidyl Peptidase 4 Inhibitor [EPC], Dipeptidyl Peptidase 4 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
Sitagliptin Phosphate
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SITAGLIPTIN PHOSPHATE25 mg/1

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
fd232072-39c4-4416-9b66-265d18a7bd93Product name120180306
25391a6f-d1ba-6bff-d36e-050dc68ef0e6Product name120140508
2de6e143-c970-2061-1b77-61c3aa8f4026Product name120140508
9fa860f8-41a8-caa8-93ae-a5bdc7b15db7Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0781-5766-31Sitagliptin Phosphate30 in 1 BOTTLETABLET, FILM COATED305
0781-5766-92Sitagliptin Phosphate90 in 1 BOTTLETABLET, FILM COATED905

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2709603SITagliptin phosphate 100 MG Oral TabletPSNcebc8388-c9db-4e27-8d6b-0d9bdc9d766d5
2709612SITagliptin phosphate 25 MG Oral TabletPSNcebc8388-c9db-4e27-8d6b-0d9bdc9d766d5
2709603sitagliptin phosphate 100 MG Oral TabletSCDcebc8388-c9db-4e27-8d6b-0d9bdc9d766d5
2709612sitagliptin phosphate 25 MG Oral TabletSCDcebc8388-c9db-4e27-8d6b-0d9bdc9d766d5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
0781-5766-310078157663130 TABLET, FILM COATED in 1 BOTTLE (0781-5766-31) 2026-01-14NoNoHistorical
0781-5766-920078157669290 TABLET, FILM COATED in 1 BOTTLE (0781-5766-92) 2026-01-14NoNoHistorical