Home NDC 45802-238 Alogliptin and Pioglitazone
Product NDC 45802-238
11-digit product format 458020238
Labeler code 45802
Product ID 45802-238_35a2f49d-f0e8-4e6a-a9ae-a37484c0e7e7
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Alogliptin Benzoate and Pioglitazone hydrochloride
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Padagis Israel Pharmaceuticals Ltd
Application NDA022426
Marketing category NDA AUTHORIZED GENERIC
Marketing start 2016-04-08
Marketing end 0000-00-00
Substance ALOGLIPTIN BENZOATE; PIOGLITAZONE HYDROCHLORIDE
Active strength 13 mg/1; mg/1
Pharmacologic classes Dipeptidyl Peptidase 4 Inhibitor [EPC], Dipeptidyl Peptidase 4 Inhibitors [MoA], PPAR alpha [CS], PPAR gamma [CS], Peroxisome Proliferator Receptor alpha Agonist [EPC], Peroxisome Proliferator Receptor gamma Agonist [EPC], Peroxisome Proliferator-activated Receptor Activity [MoA], Thiazolidinedione [EPC], Thiazolidinediones [CS]
NDC exclude flag No
Listing certified through 2023-12-31
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 22 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 45802-238-65 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 45802-238-65 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 45802-238-65 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 45802-238-65 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 45802-238-65 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 45802-238-65 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 45802-238-65 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 45802-238-65 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 45802-238-65 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 45802-238-65 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 45802-238-65 367a005e9d99…383a685ebd0f…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
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 · 246 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 2026-02-19 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…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022426-005 OSENI EQ 12.5MG BASE;EQ 30MG BASE TABLET / ORAL RLD 2013-01-25 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022426-006 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 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022426-001 OSENI EQ 25MG BASE;EQ 15MG BASE TABLET / ORAL RLD 2013-01-25 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022426-002 OSENI EQ 25MG BASE;EQ 30MG BASE TABLET / ORAL RLD 2013-01-25 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022426-003 OSENI EQ 25MG BASE;EQ 45MG BASE TABLET / ORAL RLD, RS 2013-01-25 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 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 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022426-005 OSENI EQ 12.5MG BASE;EQ 30MG BASE TABLET / ORAL RLD 2013-01-25 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 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 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022426-001 OSENI EQ 25MG BASE;EQ 15MG BASE TABLET / ORAL RLD 2013-01-25 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022426-002 OSENI EQ 25MG BASE;EQ 30MG BASE TABLET / ORAL RLD 2013-01-25 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022426-003 OSENI EQ 25MG BASE;EQ 45MG BASE TABLET / ORAL RLD, RS 2013-01-25 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 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 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022426-005 OSENI EQ 12.5MG BASE;EQ 30MG BASE TABLET / ORAL RLD 2013-01-25 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 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 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022426-001 OSENI EQ 25MG BASE;EQ 15MG BASE TABLET / ORAL RLD 2013-01-25 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022426-002 OSENI EQ 25MG BASE;EQ 30MG BASE TABLET / ORAL RLD 2013-01-25 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022426-003 OSENI EQ 25MG BASE;EQ 45MG BASE TABLET / ORAL RLD, RS 2013-01-25 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 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 2680178bc6a6…
Observed Orange Book patent history# Patent history page 1 of 28 · 1,082 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 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…2026-02-19 14:30 UTC 2026-02 N022426-003 7807689 2028-06-27 U-1337 Drug substance, Drug product 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022426-003 8637079 2029-06-04 Drug product 2014-02-13 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022426-004 7807689 2028-06-27 U-1337 Drug substance, Drug product 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022426-004 8637079 2029-06-04 Drug product 2014-02-13 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022426-005 7807689 2028-06-27 U-1337 Drug substance, Drug product 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022426-005 8637079 2029-06-04 Drug product 2014-02-13 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022426-006 7807689 2028-06-27 U-1337 Drug substance, Drug product 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022426-006 8637079 2029-06-04 Drug product 2014-02-13 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022426-001 8173663 2025-03-15 U-1338 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022426-001 8288539 2025-03-15 Drug substance 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022426-001 7807689 2028-06-27 U-1337 Drug substance, Drug product 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022426-001 8637079 2029-06-04 Drug product 2014-02-13 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022426-002 8173663 2025-03-15 U-1338 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022426-002 8288539 2025-03-15 Drug substance 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022426-002 7807689 2028-06-27 U-1337 Drug substance, Drug product 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022426-002 8637079 2029-06-04 Drug product 2014-02-13 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022426-003 8173663 2025-03-15 U-1338 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022426-003 8288539 2025-03-15 Drug substance 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022426-003 7807689 2028-06-27 U-1337 Drug substance, Drug product 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022426-003 8637079 2029-06-04 Drug product 2014-02-13 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022426-004 8173663 2025-03-15 U-1338 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022426-004 8288539 2025-03-15 Drug substance 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022426-004 7807689 2028-06-27 U-1337 Drug substance, Drug product 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022426-004 8637079 2029-06-04 Drug product 2014-02-13 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022426-005 8173663 2025-03-15 U-1338 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022426-005 8288539 2025-03-15 Drug substance 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022426-005 7807689 2028-06-27 U-1337 Drug substance, Drug product 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022426-005 8637079 2029-06-04 Drug product 2014-02-13 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022426-006 8173663 2025-03-15 U-1338 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022426-006 8288539 2025-03-15 Drug substance 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022426-006 7807689 2028-06-27 U-1337 Drug substance, Drug product 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022426-006 8637079 2029-06-04 Drug product 2014-02-13 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N022426-001 8173663 2025-03-15 U-1338 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022426-001 8288539 2025-03-15 Drug substance 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022426-001 7807689 2028-06-27 U-1337 Drug substance, Drug product 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022426-001 8637079 2029-06-04 Drug product 2014-02-13 6a471c1ec25d…
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 · 2 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 45802-238-65 45802023865 30 TABLET, FILM COATED in 1 BOTTLE (45802-238-65) 2016-04-08 0000-00-00 No No Current