Home DailyMed 0f69965d-e473-4704-9ea6-ec462c66d592 National Council for Prescription Drug Programs indexing - billing unit Drug label information. FDA.report displays public Structured Product Labeling data from DailyMed and legacy FDA.report DailyMed cache rows. This page is not medical advice, prescribing advice, or a substitute for the official label reviewed by a qualified healthcare professional. Labeling can change; when a current hydrated DailyMed SPL record is available, FDA.report shows that newer record before legacy cached files.
Manufacturer National Council for Prescription Drug Programs
Effective date 2012-07-24
Label type Indexing - Billing Unit
Version 1
Source full-release
Hydrated at 2026-06-05 01:09:40 Orange Book application contexts# All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.
Orange Book application contexts page 1 of 1 · 1 matching rows.
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 N021995-001 JANUVIA SITAGLIPTIN PHOSPHATE EQ 25MG BASE TABLET / ORAL AB RLD 2006-10-16 N021995-002 JANUVIA SITAGLIPTIN PHOSPHATE EQ 50MG BASE TABLET / ORAL AB RLD 2006-10-16 N021995-003 JANUVIA SITAGLIPTIN PHOSPHATE EQ 100MG BASE TABLET / ORAL AB RLD, RS 2006-10-16
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 matching rows.
Orange Book patents# Current patent rows page 1 of 1 · 6 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N021995-001 7326708 2026-11-24 U-802 Drug substance, Drug product N021995-001 7326708*PED 2027-05-24 Pediatric extension N021995-002 7326708 2026-11-24 U-802 Drug substance, Drug product N021995-002 7326708*PED 2027-05-24 Pediatric extension N021995-003 7326708 2026-11-24 U-802 Drug substance, Drug product N021995-003 7326708*PED 2027-05-24 Pediatric extension
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.
Product history page 1 of 4 · 129 observed 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 N021995-001 JANUVIA EQ 25MG BASE TABLET / ORAL AB RLD 2006-10-16 84e616aacf4f…2026-09-14 22:38:34 2026-08 N021995-002 JANUVIA EQ 50MG BASE TABLET / ORAL AB RLD 2006-10-16 84e616aacf4f…2026-09-14 22:38:34 2026-08 N021995-003 JANUVIA EQ 100MG BASE TABLET / ORAL AB RLD, RS 2006-10-16 84e616aacf4f…2026-08-18 06:07:40 2026-07 N021995-001 JANUVIA EQ 25MG BASE TABLET / ORAL AB RLD 2006-10-16 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N021995-002 JANUVIA EQ 50MG BASE TABLET / ORAL AB RLD 2006-10-16 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N021995-003 JANUVIA EQ 100MG BASE TABLET / ORAL AB RLD, RS 2006-10-16 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N021995-001 JANUVIA EQ 25MG BASE TABLET / ORAL AB RLD 2006-10-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021995-002 JANUVIA EQ 50MG BASE TABLET / ORAL AB RLD 2006-10-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021995-003 JANUVIA EQ 100MG BASE TABLET / ORAL AB RLD, RS 2006-10-16 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021995-001 JANUVIA EQ 25MG BASE TABLET / ORAL RLD 2006-10-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021995-002 JANUVIA EQ 50MG BASE TABLET / ORAL RLD 2006-10-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021995-003 JANUVIA EQ 100MG BASE TABLET / ORAL RLD, RS 2006-10-16 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N021995-001 JANUVIA EQ 25MG BASE TABLET / ORAL RLD 2006-10-16 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021995-002 JANUVIA EQ 50MG BASE TABLET / ORAL RLD 2006-10-16 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021995-003 JANUVIA EQ 100MG BASE TABLET / ORAL RLD, RS 2006-10-16 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021995-001 JANUVIA EQ 25MG BASE TABLET / ORAL RLD 2006-10-16 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021995-002 JANUVIA EQ 50MG BASE TABLET / ORAL RLD 2006-10-16 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021995-003 JANUVIA EQ 100MG BASE TABLET / ORAL RLD, RS 2006-10-16 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021995-001 JANUVIA EQ 25MG BASE TABLET / ORAL RLD 2006-10-16 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021995-002 JANUVIA EQ 50MG BASE TABLET / ORAL RLD 2006-10-16 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021995-003 JANUVIA EQ 100MG BASE TABLET / ORAL RLD, RS 2006-10-16 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021995-001 JANUVIA EQ 25MG BASE TABLET / ORAL RLD 2006-10-16 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021995-002 JANUVIA EQ 50MG BASE TABLET / ORAL RLD 2006-10-16 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021995-003 JANUVIA EQ 100MG BASE TABLET / ORAL RLD, RS 2006-10-16 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021995-001 JANUVIA EQ 25MG BASE TABLET / ORAL RLD 2006-10-16 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021995-002 JANUVIA EQ 50MG BASE TABLET / ORAL RLD 2006-10-16 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021995-003 JANUVIA EQ 100MG BASE TABLET / ORAL RLD, RS 2006-10-16 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021995-001 JANUVIA EQ 25MG BASE TABLET / ORAL RLD 2006-10-16 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021995-002 JANUVIA EQ 50MG BASE TABLET / ORAL RLD 2006-10-16 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021995-003 JANUVIA EQ 100MG BASE TABLET / ORAL RLD, RS 2006-10-16 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021995-001 JANUVIA EQ 25MG BASE TABLET / ORAL RLD 2006-10-16 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021995-002 JANUVIA EQ 50MG BASE TABLET / ORAL RLD 2006-10-16 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021995-003 JANUVIA EQ 100MG BASE TABLET / ORAL RLD, RS 2006-10-16 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N021995-001 JANUVIA EQ 25MG BASE TABLET / ORAL RLD 2006-10-16 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N021995-002 JANUVIA EQ 50MG BASE TABLET / ORAL RLD 2006-10-16 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N021995-003 JANUVIA EQ 100MG BASE TABLET / ORAL RLD, RS 2006-10-16 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021995-001 JANUVIA EQ 25MG BASE TABLET / ORAL RLD 2006-10-16 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021995-002 JANUVIA EQ 50MG BASE TABLET / ORAL RLD 2006-10-16 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021995-003 JANUVIA EQ 100MG BASE TABLET / ORAL RLD, RS 2006-10-16 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021995-001 JANUVIA EQ 25MG BASE TABLET / ORAL RLD 2006-10-16 301d65b070ca…
Observed Orange Book normalized TE history# Observed Orange Book patent history# Patent history page 1 of 17 · 663 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-09-14 22:38:34 2026-08 N021995-001 7326708 2026-11-24 U-802 Drug substance, Drug product 84e616aacf4f…2026-09-14 22:38:34 2026-08 N021995-001 7326708*PED 2027-05-24 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N021995-002 7326708 2026-11-24 U-802 Drug substance, Drug product 84e616aacf4f…2026-09-14 22:38:34 2026-08 N021995-002 7326708*PED 2027-05-24 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N021995-003 7326708 2026-11-24 U-802 Drug substance, Drug product 84e616aacf4f…2026-09-14 22:38:34 2026-08 N021995-003 7326708*PED 2027-05-24 Pediatric extension 84e616aacf4f…2026-08-18 06:07:40 2026-07 N021995-001 7326708 2026-11-24 U-802 Drug substance, Drug product caaa826d4ba7…2026-08-18 06:07:40 2026-07 N021995-001 7326708*PED 2027-05-24 Pediatric extension caaa826d4ba7…2026-08-18 06:07:40 2026-07 N021995-002 7326708 2026-11-24 U-802 Drug substance, Drug product caaa826d4ba7…2026-08-18 06:07:40 2026-07 N021995-002 7326708*PED 2027-05-24 Pediatric extension caaa826d4ba7…2026-08-18 06:07:40 2026-07 N021995-003 7326708 2026-11-24 U-802 Drug substance, Drug product caaa826d4ba7…2026-08-18 06:07:40 2026-07 N021995-003 7326708*PED 2027-05-24 Pediatric extension caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N021995-001 7326708 2026-11-24 U-802 Drug substance, Drug product 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021995-001 7326708*PED 2027-05-24 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021995-002 7326708 2026-11-24 U-802 Drug substance, Drug product 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021995-002 7326708*PED 2027-05-24 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021995-003 7326708 2026-11-24 U-802 Drug substance, Drug product 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021995-003 7326708*PED 2027-05-24 Pediatric extension 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021995-001 7326708 2026-11-24 U-802 Drug substance, Drug product 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021995-001 7326708*PED 2027-05-24 Pediatric extension 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021995-002 7326708 2026-11-24 U-802 Drug substance, Drug product 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021995-002 7326708*PED 2027-05-24 Pediatric extension 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021995-003 7326708 2026-11-24 U-802 Drug substance, Drug product 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021995-003 7326708*PED 2027-05-24 Pediatric extension 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N021995-001 7326708 2026-11-24 U-802 Drug substance, Drug product 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021995-001 7326708*PED 2027-05-24 Pediatric extension 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021995-002 7326708 2026-11-24 U-802 Drug substance, Drug product 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021995-002 7326708*PED 2027-05-24 Pediatric extension 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021995-003 7326708 2026-11-24 U-802 Drug substance, Drug product 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021995-003 7326708*PED 2027-05-24 Pediatric extension 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021995-001 7326708 2026-11-24 U-802 Drug substance, Drug product fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021995-001 7326708*PED 2027-05-24 Pediatric extension fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021995-002 7326708 2026-11-24 U-802 Drug substance, Drug product fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021995-002 7326708*PED 2027-05-24 Pediatric extension fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021995-003 7326708 2026-11-24 U-802 Drug substance, Drug product fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021995-003 7326708*PED 2027-05-24 Pediatric extension fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021995-001 7326708 2026-11-24 U-802 Drug substance, Drug product b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021995-001 7326708*PED 2027-05-24 Pediatric extension b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021995-002 7326708 2026-11-24 U-802 Drug substance, Drug product b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021995-002 7326708*PED 2027-05-24 Pediatric extension b8a1b40f171c…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 7 · 279 observed states.
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.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.