Home DailyMed ccdc0409-5cee-49e5-8466-1464f4cc4670 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 2013-02-13
Label type Indexing - Billing Unit
Version 1
Source full-release
Hydrated at 2026-06-05 03:22:51 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 44 .
Orange Book products# Current product rows page 1 of 1 · 6 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N022426-001 OSENI ALOGLIPTIN BENZOATE; PIOGLITAZONE HYDROCHLORIDE EQ 25MG BASE;EQ 15MG BASE TABLET / ORAL RLD 2013-01-25 N022426-002 OSENI ALOGLIPTIN BENZOATE; PIOGLITAZONE HYDROCHLORIDE EQ 25MG BASE;EQ 30MG BASE TABLET / ORAL RLD 2013-01-25 N022426-003 OSENI ALOGLIPTIN BENZOATE; PIOGLITAZONE HYDROCHLORIDE EQ 25MG BASE;EQ 45MG BASE TABLET / ORAL RLD, RS 2013-01-25 N022426-004 OSENI ALOGLIPTIN BENZOATE; PIOGLITAZONE HYDROCHLORIDE EQ 12.5MG BASE;EQ 15MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2013-01-25 N022426-005 OSENI ALOGLIPTIN BENZOATE; PIOGLITAZONE HYDROCHLORIDE EQ 12.5MG BASE;EQ 30MG BASE TABLET / ORAL RLD 2013-01-25 N022426-006 OSENI ALOGLIPTIN BENZOATE; PIOGLITAZONE HYDROCHLORIDE EQ 12.5MG BASE;EQ 45MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2013-01-25
Orange Book patents# Current patent rows page 1 of 1 · 12 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N022426-001 7807689 2028-06-27 U-1337 Drug substance, Drug product N022426-001 8637079 2029-06-04 Drug product 2014-02-13 N022426-002 7807689 2028-06-27 U-1337 Drug substance, Drug product N022426-002 8637079 2029-06-04 Drug product 2014-02-13 N022426-003 7807689 2028-06-27 U-1337 Drug substance, Drug product N022426-003 8637079 2029-06-04 Drug product 2014-02-13 N022426-004 7807689 2028-06-27 U-1337 Drug substance, Drug product N022426-004 8637079 2029-06-04 Drug product 2014-02-13 N022426-005 7807689 2028-06-27 U-1337 Drug substance, Drug product N022426-005 8637079 2029-06-04 Drug product 2014-02-13 N022426-006 7807689 2028-06-27 U-1337 Drug substance, Drug product N022426-006 8637079 2029-06-04 Drug product 2014-02-13
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 7 · 264 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 2026-10-15 13:18:30 2026-09 N022426-001 OSENI EQ 25MG BASE;EQ 15MG BASE TABLET / ORAL RLD 2013-01-25 c2088c7a36db…2026-10-15 13:18:30 2026-09 N022426-002 OSENI EQ 25MG BASE;EQ 30MG BASE TABLET / ORAL RLD 2013-01-25 c2088c7a36db…2026-10-15 13:18:30 2026-09 N022426-003 OSENI EQ 25MG BASE;EQ 45MG BASE TABLET / ORAL RLD, RS 2013-01-25 c2088c7a36db…2026-10-15 13:18:30 2026-09 N022426-004 OSENI EQ 12.5MG BASE;EQ 15MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2013-01-25 c2088c7a36db…2026-10-15 13:18:30 2026-09 N022426-005 OSENI EQ 12.5MG BASE;EQ 30MG BASE TABLET / ORAL RLD 2013-01-25 c2088c7a36db…2026-10-15 13:18:30 2026-09 N022426-006 OSENI EQ 12.5MG BASE;EQ 45MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2013-01-25 c2088c7a36db…2026-09-14 22:38:34 2026-08 N022426-001 OSENI EQ 25MG BASE;EQ 15MG BASE TABLET / ORAL RLD 2013-01-25 84e616aacf4f…2026-09-14 22:38:34 2026-08 N022426-002 OSENI EQ 25MG BASE;EQ 30MG BASE TABLET / ORAL RLD 2013-01-25 84e616aacf4f…2026-09-14 22:38:34 2026-08 N022426-003 OSENI EQ 25MG BASE;EQ 45MG BASE TABLET / ORAL RLD, RS 2013-01-25 84e616aacf4f…2026-09-14 22:38:34 2026-08 N022426-004 OSENI EQ 12.5MG BASE;EQ 15MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2013-01-25 84e616aacf4f…2026-09-14 22:38:34 2026-08 N022426-005 OSENI EQ 12.5MG BASE;EQ 30MG BASE TABLET / ORAL RLD 2013-01-25 84e616aacf4f…2026-09-14 22:38:34 2026-08 N022426-006 OSENI EQ 12.5MG BASE;EQ 45MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2013-01-25 84e616aacf4f…2026-08-18 06:07:40 2026-07 N022426-001 OSENI EQ 25MG BASE;EQ 15MG BASE TABLET / ORAL RLD 2013-01-25 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022426-002 OSENI EQ 25MG BASE;EQ 30MG BASE TABLET / ORAL RLD 2013-01-25 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022426-003 OSENI EQ 25MG BASE;EQ 45MG BASE TABLET / ORAL RLD, RS 2013-01-25 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022426-004 OSENI EQ 12.5MG BASE;EQ 15MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2013-01-25 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022426-005 OSENI EQ 12.5MG BASE;EQ 30MG BASE TABLET / ORAL RLD 2013-01-25 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022426-006 OSENI EQ 12.5MG BASE;EQ 45MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2013-01-25 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N022426-001 OSENI EQ 25MG BASE;EQ 15MG BASE TABLET / ORAL RLD 2013-01-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022426-002 OSENI EQ 25MG BASE;EQ 30MG BASE TABLET / ORAL RLD 2013-01-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022426-003 OSENI EQ 25MG BASE;EQ 45MG BASE TABLET / ORAL RLD, RS 2013-01-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022426-004 OSENI EQ 12.5MG BASE;EQ 15MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2013-01-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022426-005 OSENI EQ 12.5MG BASE;EQ 30MG BASE TABLET / ORAL RLD 2013-01-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022426-006 OSENI EQ 12.5MG BASE;EQ 45MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2013-01-25 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022426-001 OSENI EQ 25MG BASE;EQ 15MG BASE TABLET / ORAL RLD 2013-01-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022426-002 OSENI EQ 25MG BASE;EQ 30MG BASE TABLET / ORAL RLD 2013-01-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022426-003 OSENI EQ 25MG BASE;EQ 45MG BASE TABLET / ORAL RLD, RS 2013-01-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022426-004 OSENI EQ 12.5MG BASE;EQ 15MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2013-01-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022426-005 OSENI EQ 12.5MG BASE;EQ 30MG BASE TABLET / ORAL RLD 2013-01-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022426-006 OSENI EQ 12.5MG BASE;EQ 45MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2013-01-25 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N022426-001 OSENI EQ 25MG BASE;EQ 15MG BASE TABLET / ORAL RLD 2013-01-25 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022426-002 OSENI EQ 25MG BASE;EQ 30MG BASE TABLET / ORAL RLD 2013-01-25 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022426-003 OSENI EQ 25MG BASE;EQ 45MG BASE TABLET / ORAL RLD, RS 2013-01-25 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022426-004 OSENI EQ 12.5MG BASE;EQ 15MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2013-01-25 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022426-005 OSENI EQ 12.5MG BASE;EQ 30MG BASE TABLET / ORAL RLD 2013-01-25 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022426-006 OSENI EQ 12.5MG BASE;EQ 45MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2013-01-25 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022426-001 OSENI EQ 25MG BASE;EQ 15MG BASE TABLET / ORAL RLD 2013-01-25 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022426-002 OSENI EQ 25MG BASE;EQ 30MG BASE TABLET / ORAL RLD 2013-01-25 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022426-003 OSENI EQ 25MG BASE;EQ 45MG BASE TABLET / ORAL RLD, RS 2013-01-25 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022426-004 OSENI EQ 12.5MG BASE;EQ 15MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2013-01-25 fd3edfee7708…
Observed Orange Book patent history# Patent history page 1 of 28 · 1,118 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-10-15 13:18:30 2026-09 N022426-001 7807689 2028-06-27 U-1337 Drug substance, Drug product c2088c7a36db…2026-10-15 13:18:30 2026-09 N022426-001 8637079 2029-06-04 Drug product 2014-02-13 c2088c7a36db…2026-10-15 13:18:30 2026-09 N022426-002 7807689 2028-06-27 U-1337 Drug substance, Drug product c2088c7a36db…2026-10-15 13:18:30 2026-09 N022426-002 8637079 2029-06-04 Drug product 2014-02-13 c2088c7a36db…2026-10-15 13:18:30 2026-09 N022426-003 7807689 2028-06-27 U-1337 Drug substance, Drug product c2088c7a36db…2026-10-15 13:18:30 2026-09 N022426-003 8637079 2029-06-04 Drug product 2014-02-13 c2088c7a36db…2026-10-15 13:18:30 2026-09 N022426-004 7807689 2028-06-27 U-1337 Drug substance, Drug product c2088c7a36db…2026-10-15 13:18:30 2026-09 N022426-004 8637079 2029-06-04 Drug product 2014-02-13 c2088c7a36db…2026-10-15 13:18:30 2026-09 N022426-005 7807689 2028-06-27 U-1337 Drug substance, Drug product c2088c7a36db…2026-10-15 13:18:30 2026-09 N022426-005 8637079 2029-06-04 Drug product 2014-02-13 c2088c7a36db…2026-10-15 13:18:30 2026-09 N022426-006 7807689 2028-06-27 U-1337 Drug substance, Drug product c2088c7a36db…2026-10-15 13:18:30 2026-09 N022426-006 8637079 2029-06-04 Drug product 2014-02-13 c2088c7a36db…2026-09-14 22:38:34 2026-08 N022426-001 7807689 2028-06-27 U-1337 Drug substance, Drug product 84e616aacf4f…2026-09-14 22:38:34 2026-08 N022426-001 8637079 2029-06-04 Drug product 2014-02-13 84e616aacf4f…2026-09-14 22:38:34 2026-08 N022426-002 7807689 2028-06-27 U-1337 Drug substance, Drug product 84e616aacf4f…2026-09-14 22:38:34 2026-08 N022426-002 8637079 2029-06-04 Drug product 2014-02-13 84e616aacf4f…2026-09-14 22:38:34 2026-08 N022426-003 7807689 2028-06-27 U-1337 Drug substance, Drug product 84e616aacf4f…2026-09-14 22:38:34 2026-08 N022426-003 8637079 2029-06-04 Drug product 2014-02-13 84e616aacf4f…2026-09-14 22:38:34 2026-08 N022426-004 7807689 2028-06-27 U-1337 Drug substance, Drug product 84e616aacf4f…2026-09-14 22:38:34 2026-08 N022426-004 8637079 2029-06-04 Drug product 2014-02-13 84e616aacf4f…2026-09-14 22:38:34 2026-08 N022426-005 7807689 2028-06-27 U-1337 Drug substance, Drug product 84e616aacf4f…2026-09-14 22:38:34 2026-08 N022426-005 8637079 2029-06-04 Drug product 2014-02-13 84e616aacf4f…2026-09-14 22:38:34 2026-08 N022426-006 7807689 2028-06-27 U-1337 Drug substance, Drug product 84e616aacf4f…2026-09-14 22:38:34 2026-08 N022426-006 8637079 2029-06-04 Drug product 2014-02-13 84e616aacf4f…2026-08-18 06:07:40 2026-07 N022426-001 7807689 2028-06-27 U-1337 Drug substance, Drug product caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022426-001 8637079 2029-06-04 Drug product 2014-02-13 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022426-002 7807689 2028-06-27 U-1337 Drug substance, Drug product caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022426-002 8637079 2029-06-04 Drug product 2014-02-13 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022426-003 7807689 2028-06-27 U-1337 Drug substance, Drug product caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022426-003 8637079 2029-06-04 Drug product 2014-02-13 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022426-004 7807689 2028-06-27 U-1337 Drug substance, Drug product caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022426-004 8637079 2029-06-04 Drug product 2014-02-13 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022426-005 7807689 2028-06-27 U-1337 Drug substance, Drug product caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022426-005 8637079 2029-06-04 Drug product 2014-02-13 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022426-006 7807689 2028-06-27 U-1337 Drug substance, Drug product caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022426-006 8637079 2029-06-04 Drug product 2014-02-13 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N022426-001 7807689 2028-06-27 U-1337 Drug substance, Drug product 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022426-001 8637079 2029-06-04 Drug product 2014-02-13 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022426-002 7807689 2028-06-27 U-1337 Drug substance, Drug product 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022426-002 8637079 2029-06-04 Drug product 2014-02-13 011fe1cb6892…
Observed Orange Book exclusivity history# 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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join OSENI ALOGLIPTIN AND PIOGLITAZONE Takeda Pharmaceuticals America, Inc. 4c619ed9-fe3e-4158-9938-80c6c3493d55 2025-02-28 Boxed warning, Warnings, Adverse reactions Exact identifier ndc (package): 64764-254-03 ndc11 (package): 64764025403
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.