Home NDC 0480-2609-10 Sitagliptin
Product NDC 0480-2609
Requested package NDC 0480-2609-10
11-digit product format 004802609
Labeler code 0480
Product ID 0480-2609_ab518e96-e35b-40b1-b7e8-b4e01ada32eb
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Sitagliptin
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Teva Pharmaceuticals, Inc.
Application ANDA202327
Marketing category ANDA
Marketing start 2026-05-28
Substance SITAGLIPTIN PHOSPHATE
Active strength 100 mg/1
Pharmacologic classes Dipeptidyl Peptidase 4 Inhibitor [EPC]; Dipeptidyl Peptidase 4 Inhibitors [MoA]
Listing certified through 2027-12-31
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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A202327-001 SITAGLIPTIN PHOSPHATE SITAGLIPTIN PHOSPHATE EQ 25MG BASE TABLET / ORAL AB 2025-12-30 A202327-002 SITAGLIPTIN PHOSPHATE SITAGLIPTIN PHOSPHATE EQ 50MG BASE TABLET / ORAL AB 2025-12-30 A202327-003 SITAGLIPTIN PHOSPHATE SITAGLIPTIN PHOSPHATE EQ 100MG BASE TABLET / ORAL AB 2025-12-30
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 matching rows.
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 A202327-001 SITAGLIPTIN PHOSPHATE EQ 25MG BASE TABLET / ORAL AB 2025-12-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A202327-002 SITAGLIPTIN PHOSPHATE EQ 50MG BASE TABLET / ORAL AB 2025-12-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A202327-003 SITAGLIPTIN PHOSPHATE EQ 100MG BASE TABLET / ORAL AB 2025-12-30 011fe1cb6892…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A202327-001 SITAGLIPTIN PHOSPHATE EQ 25MG BASE TABLET / ORAL AB 2025-12-30 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A202327-002 SITAGLIPTIN PHOSPHATE EQ 50MG BASE TABLET / ORAL AB 2025-12-30 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A202327-003 SITAGLIPTIN PHOSPHATE EQ 100MG BASE TABLET / ORAL AB 2025-12-30 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Sitagliptin
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength SITAGLIPTIN PHOSPHATE 100 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination TS63EW8X6F Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2709603 Internal RxNorm lookup 2709608 Internal RxNorm lookup 2709612 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# 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 · 1 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Status 0480-2609-10 00480260910 1000 TABLET, FILM COATED in 1 BOTTLE (0480-2609-10) 2026-05-28 0 Current