Home NDC 45802-351 Alogliptin and Pioglitazone
Product NDC 45802-351
11-digit product format 458020351
Labeler code 45802
Product ID 45802-351_11c471e0-6c64-4f13-b6ed-d2c80bc89f20
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
Substance ALOGLIPTIN BENZOATE; PIOGLITAZONE HYDROCHLORIDE
Active strength 25; 15 mg/1; mg/1
Pharmacologic classes Dipeptidyl Peptidase 4 Inhibitor [EPC], Dipeptidyl Peptidase 4 Inhibitors [MoA], Peroxisome Proliferator Receptor alpha Agonist [EPC], Peroxisome Proliferator Receptor gamma Agonist [EPC], Peroxisome Proliferator-activated Receptor alpha Agonists [MoA], Peroxisome Proliferator-activated Receptor gamma Agonists [MoA], Thiazolidinedione [EPC], Thiazolidinediones [CS]
NDC exclude flag No
Listing certified through 2026-12-31
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 · 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HYDROCHLORIDE EQ 12.5MG BASE;EQ 15MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2013-01-25 N022426-005 OSENI ALOGLIPTIN BENZOATE; PIOGLITAZONE HYDROCHLORIDE EQ 12.5MG BASE;EQ 30MG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HYDROCHLORIDE EQ 12.5MG BASE;EQ 45MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2013-01-25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 · 258 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 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…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…
Observed Orange Book patent history# Patent history page 1 of 28 · 1,106 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 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…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…
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 Alogliptin and Pioglitazone
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ALOGLIPTIN BENZOATE 25 mg/1 PIOGLITAZONE HYDROCHLORIDE 15 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination JQT35NPK6C Internal UNII lookup EEN99869SC Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1368410 Internal RxNorm lookup 1368424 Internal RxNorm lookup 1368431 Internal RxNorm lookup 1368438 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 45802-351-65 Alogliptin and Pioglitazone 30 in 1 BOTTLE TABLET, FILM COATED 30 11
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 45802-351 ALOGLIPTIN AND PIOGLITAZONE (ALOGLIPTIN BENZOATE AND PIOGLITAZONE HYDROCHLORIDE) TABLET, FILM COATED [PADAGIS ISRAEL PHARMACEUTICALS LTD] 10 Current NDC, Legacy NDC, 1 package rows 20240915_642b1e90-701e-42f2-bac6-a4918738e2c9.zip
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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 45802-351-65 45802035165 30 TABLET, FILM COATED in 1 BOTTLE (45802-351-65) 2016-04-08 0000-00-00 No No Current