Home DailyMed c643ed33-e902-4dc5-8e40-934202846304 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 03:22:19 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HYDROCHLORIDE EQ 12.5MG BASE;EQ 15MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2013-01-25 N022426-005 OSENI ALOGLIPTIN BENZOATE; PIOGLITAZONE HYDROCHLORIDE EQ 12.5MG BASE;EQ 30MG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HYDROCHLORIDE EQ 12.5MG BASE;EQ 45MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2013-01-25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# Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.