Home NDC 60505-3644 Sitagliptin
Product NDC 60505-3644
11-digit product format 605053644
Labeler code 60505
Product ID 60505-3644_70a9a9c7-ce7d-fdee-0b71-3db55d04f032
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 50 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 Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
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 2026-10-15 13:18:30 2026-09 A202425-001 SITAGLIPTIN PHOSPHATE EQ 25MG BASE TABLET / ORAL AB 2026-01-20 c2088c7a36db…2026-10-15 13:18:30 2026-09 A202425-002 SITAGLIPTIN PHOSPHATE EQ 50MG BASE TABLET / ORAL AB 2026-01-20 c2088c7a36db…2026-10-15 13:18:30 2026-09 A202425-003 SITAGLIPTIN PHOSPHATE EQ 100MG BASE TABLET / ORAL AB 2026-01-20 c2088c7a36db…2026-09-14 22:38:34 2026-08 A202425-001 SITAGLIPTIN PHOSPHATE EQ 25MG BASE TABLET / ORAL AB 2026-01-20 84e616aacf4f…2026-09-14 22:38:34 2026-08 A202425-002 SITAGLIPTIN PHOSPHATE EQ 50MG BASE TABLET / ORAL AB 2026-01-20 84e616aacf4f…2026-09-14 22:38:34 2026-08 A202425-003 SITAGLIPTIN PHOSPHATE EQ 100MG BASE TABLET / ORAL AB 2026-01-20 84e616aacf4f…2026-08-18 06:07:40 2026-07 A202425-001 SITAGLIPTIN PHOSPHATE EQ 25MG BASE TABLET / ORAL AB 2026-01-20 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A202425-002 SITAGLIPTIN PHOSPHATE EQ 50MG BASE TABLET / ORAL AB 2026-01-20 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A202425-003 SITAGLIPTIN PHOSPHATE EQ 100MG BASE TABLET / ORAL AB 2026-01-20 caaa826d4ba7…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# Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Sitagliptin
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength SITAGLIPTIN PHOSPHATE 50 mg/1
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 60505-3644-3 Sitagliptin 30 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 30 2 60505-3644-9 Sitagliptin 90 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 90 2
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 60505-3644-3 60505364403 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (60505-3644-3) 2026-05-28 No No Current 60505-3644-9 60505364409 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (60505-3644-9) 2026-05-28 No No Current