Home NDC 60505-3643 Sitagliptin
Product NDC 60505-3643
11-digit product format 605053643
Labeler code 60505
Product ID 60505-3643_ab7f33cf-8dbc-f58a-ddb8-8c758e9e0fcd
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Sitagliptin
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Apotex Corp.
Application ANDA202425
Marketing category ANDA
Marketing start 2026-05-28
Substance SITAGLIPTIN PHOSPHATE
Active strength 25 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 A202425-001 SITAGLIPTIN PHOSPHATE SITAGLIPTIN PHOSPHATE EQ 25MG BASE TABLET / ORAL AB 2026-01-20 A202425-002 SITAGLIPTIN PHOSPHATE SITAGLIPTIN PHOSPHATE EQ 50MG BASE TABLET / ORAL AB 2026-01-20 A202425-003 SITAGLIPTIN PHOSPHATE SITAGLIPTIN PHOSPHATE EQ 100MG BASE TABLET / ORAL AB 2026-01-20
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 matching rows.
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 3 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration A202425-001 PC 2026-11-24 A202425-002 PC 2026-11-24 A202425-003 PC 2026-11-24
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 A202425-001 SITAGLIPTIN PHOSPHATE EQ 25MG BASE TABLET / ORAL AB 2026-01-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A202425-002 SITAGLIPTIN PHOSPHATE EQ 50MG BASE TABLET / ORAL AB 2026-01-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A202425-003 SITAGLIPTIN PHOSPHATE EQ 100MG BASE TABLET / ORAL AB 2026-01-20 011fe1cb6892…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A202425-001 SITAGLIPTIN PHOSPHATE EQ 25MG BASE TABLET / ORAL AB 2026-01-20 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A202425-002 SITAGLIPTIN PHOSPHATE EQ 50MG BASE TABLET / ORAL AB 2026-01-20 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A202425-003 SITAGLIPTIN PHOSPHATE EQ 100MG BASE TABLET / ORAL AB 2026-01-20 a50c72e98297…
Observed Orange Book normalized TE history# Observed Orange Book exclusivity history# Captured, Edition, Application-product table Captured Edition Application-product Exclusivity code Expiration Source SHA-256 2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A202425-001 PC 2026-11-24 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A202425-002 PC 2026-11-24 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A202425-003 PC 2026-11-24 a50c72e98297…
Additional Listing Data#
Finished product Yes
Brand name base Sitagliptin
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength SITAGLIPTIN PHOSPHATE 25 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# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 60505-3643-3 Sitagliptin 30 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 30 2 60505-3643-9 Sitagliptin 90 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 90 2
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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Status 60505-3643-3 60505364303 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (60505-3643-3) 2026-05-28 0 Current 60505-3643-9 60505364309 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (60505-3643-9) 2026-05-28 0 Current