Home NDC 84677-051 Sitagliptin
Product NDC 84677-051
11-digit product format 846770051
Labeler code 84677
Product ID 84677-051_58e20de7-3df2-d310-e063-6394a90abae0
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Sitagliptin
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Golden State Medical Supply, Inc.
Application ANDA202425
Marketing category ANDA
Marketing start 2026-01-20
Substance SITAGLIPTIN PHOSPHATE
Active strength 100 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 43 .
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 2026-09-14 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 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.
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 Exclude flag Status 84677-051-30 84677005130 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (84677-051-30) 2026-06-01 No No Current 84677-051-90 84677005190 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (84677-051-90) 2026-06-01 No No Current