OSENI

Product NDC: 64764-123
11-digit product format: 647640123
Labeler code: 64764
Product ID: 64764-123_2346b7f5-b2c1-45f0-9f8f-5cbb4b202857
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: alogliptin and pioglitazone
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Takeda Pharmaceuticals America, Inc.
Application: NDA022426
Marketing category: NDA
Marketing start: 2013-01-25
Substance: ALOGLIPTIN BENZOATE; PIOGLITAZONE HYDROCHLORIDE
Active strength: 12.5; 30 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 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	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HYDROCHLORIDE	EQ 12.5MG BASE;EQ 15MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2013-01-25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HYDROCHLORIDE	EQ 12.5MG BASE;EQ 45MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2013-01-25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	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#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N022426-001	M-177	2019-04-05	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022426-002	M-177	2019-04-05	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022426-003	M-177	2019-04-05	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022426-004	M-177	2019-04-05	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022426-005	M-177	2019-04-05	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022426-006	M-177	2019-04-05	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	N022426-001	M-177	2019-04-05	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N022426-002	M-177	2019-04-05	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N022426-003	M-177	2019-04-05	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N022426-004	M-177	2019-04-05	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N022426-005	M-177	2019-04-05	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N022426-006	M-177	2019-04-05	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N022426-001	M-177	2019-04-05	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N022426-002	M-177	2019-04-05	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N022426-003	M-177	2019-04-05	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N022426-004	M-177	2019-04-05	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N022426-005	M-177	2019-04-05	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N022426-006	M-177	2019-04-05	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N022426-001	M-177	2019-04-05	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N022426-002	M-177	2019-04-05	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N022426-003	M-177	2019-04-05	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N022426-004	M-177	2019-04-05	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N022426-005	M-177	2019-04-05	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N022426-006	M-177	2019-04-05	`ea99ee380514…`

Additional Listing Data#

Finished product: Yes
Brand name base: OSENI
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ALOGLIPTIN BENZOATE	12.5 mg/1
PIOGLITAZONE HYDROCHLORIDE	30 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
EEN99869SC	Internal UNII lookup
JQT35NPK6C	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 8 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1368410	Internal RxNorm lookup
1368416	Internal RxNorm lookup
1368424	Internal RxNorm lookup
1368430	Internal RxNorm lookup
1368431	Internal RxNorm lookup
1368437	Internal RxNorm lookup
1368438	Internal RxNorm lookup
1368444	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
4c619ed9-fe3e-4158-9938-80c6c3493d55	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
e11f0f31-8914-938f-521e-037b6de27c13	Product name	5	20210621
a62a50ac-1535-4461-9768-8ae703e2e9fb	Product name	1	20210525
3e9b6ece-066b-2ac3-28f7-5e13060e5934	Product name	2	20151109
0d79b284-47e8-e90c-f249-892b9b251003	Product name	1	20140508
36db81cb-9c11-39e1-6a1a-715fc2caa47c	Product name	1	20140508
7611093e-8875-33d4-9e3c-f48c7e3af1e8	Product name	1	20140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877	Product name	1	20140508
ac29cd77-922c-d25a-f8ad-66a8692935c5	Product name	1	20140508
bc07ef78-e82d-0c19-31f4-31f263780582	Product name	1	20140508
ce63c1f8-ba50-8a17-9290-94522d75daff	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
64764-123-03	OSENI	30 in 1 BOTTLE	TABLET, FILM COATED	30	23
64764-123-04	OSENI	90 in 1 BOTTLE	TABLET, FILM COATED	90	23
64764-123-05	OSENI	500 in 1 BOTTLE	TABLET, FILM COATED	500	23

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
64764-123-03	EA - Each	64764-123	eb9755fc-799a-4a81-ae89-177d0579c6f1	1	2013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ALOGLIPTIN BENZOATE	ACTIVE INGREDIENT	EEN99869SC	OSENI (ALOGLIPTIN AND PIOGLITAZONE) TABLET, FILM COATED [TAKEDA PHARMACEUTICALS AMERICA, INC.]	5
PIOGLITAZONE HYDROCHLORIDE	ACTIVE INGREDIENT	JQT35NPK6C	OSENI (ALOGLIPTIN AND PIOGLITAZONE) TABLET, FILM COATED [TAKEDA PHARMACEUTICALS AMERICA, INC.]	5
ALOGLIPTIN	ACTIVE MOIETY	JHC049LO86	OSENI (ALOGLIPTIN AND PIOGLITAZONE) TABLET, FILM COATED [TAKEDA PHARMACEUTICALS AMERICA, INC.]	5
PIOGLITAZONE	ACTIVE MOIETY	X4OV71U42S	OSENI (ALOGLIPTIN AND PIOGLITAZONE) TABLET, FILM COATED [TAKEDA PHARMACEUTICALS AMERICA, INC.]	5
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	OSENI (ALOGLIPTIN AND PIOGLITAZONE) TABLET, FILM COATED [TAKEDA PHARMACEUTICALS AMERICA, INC.]	5
BUTYL ALCOHOL	INACTIVE INGREDIENT	8PJ61P6TS3	OSENI (ALOGLIPTIN AND PIOGLITAZONE) TABLET, FILM COATED [TAKEDA PHARMACEUTICALS AMERICA, INC.]	5
CARNAUBA WAX	INACTIVE INGREDIENT	R12CBM0EIZ	OSENI (ALOGLIPTIN AND PIOGLITAZONE) TABLET, FILM COATED [TAKEDA PHARMACEUTICALS AMERICA, INC.]	5
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	OSENI (ALOGLIPTIN AND PIOGLITAZONE) TABLET, FILM COATED [TAKEDA PHARMACEUTICALS AMERICA, INC.]	5
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	OSENI (ALOGLIPTIN AND PIOGLITAZONE) TABLET, FILM COATED [TAKEDA PHARMACEUTICALS AMERICA, INC.]	5
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	OSENI (ALOGLIPTIN AND PIOGLITAZONE) TABLET, FILM COATED [TAKEDA PHARMACEUTICALS AMERICA, INC.]	5
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	OSENI (ALOGLIPTIN AND PIOGLITAZONE) TABLET, FILM COATED [TAKEDA PHARMACEUTICALS AMERICA, INC.]	5
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	OSENI (ALOGLIPTIN AND PIOGLITAZONE) TABLET, FILM COATED [TAKEDA PHARMACEUTICALS AMERICA, INC.]	5
HYDROXYPROPYL CELLULOSE (TYPE L)	INACTIVE INGREDIENT	UKE75GEA7F	OSENI (ALOGLIPTIN AND PIOGLITAZONE) TABLET, FILM COATED [TAKEDA PHARMACEUTICALS AMERICA, INC.]	5
HYPROMELLOSE 2910 (6 MPA.S)	INACTIVE INGREDIENT	0WZ8WG20P6	OSENI (ALOGLIPTIN AND PIOGLITAZONE) TABLET, FILM COATED [TAKEDA PHARMACEUTICALS AMERICA, INC.]	5
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	OSENI (ALOGLIPTIN AND PIOGLITAZONE) TABLET, FILM COATED [TAKEDA PHARMACEUTICALS AMERICA, INC.]	5
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	OSENI (ALOGLIPTIN AND PIOGLITAZONE) TABLET, FILM COATED [TAKEDA PHARMACEUTICALS AMERICA, INC.]	5
MANNITOL	INACTIVE INGREDIENT	3OWL53L36A	OSENI (ALOGLIPTIN AND PIOGLITAZONE) TABLET, FILM COATED [TAKEDA PHARMACEUTICALS AMERICA, INC.]	5
POLYETHYLENE GLYCOL 8000	INACTIVE INGREDIENT	Q662QK8M3B	OSENI (ALOGLIPTIN AND PIOGLITAZONE) TABLET, FILM COATED [TAKEDA PHARMACEUTICALS AMERICA, INC.]	5
POLYGLYCERYL-10 OLEATE	INACTIVE INGREDIENT	55C81W76DH	OSENI (ALOGLIPTIN AND PIOGLITAZONE) TABLET, FILM COATED [TAKEDA PHARMACEUTICALS AMERICA, INC.]	5
SHELLAC	INACTIVE INGREDIENT	46N107B71O	OSENI (ALOGLIPTIN AND PIOGLITAZONE) TABLET, FILM COATED [TAKEDA PHARMACEUTICALS AMERICA, INC.]	5
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	OSENI (ALOGLIPTIN AND PIOGLITAZONE) TABLET, FILM COATED [TAKEDA PHARMACEUTICALS AMERICA, INC.]	5
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	OSENI (ALOGLIPTIN AND PIOGLITAZONE) TABLET, FILM COATED [TAKEDA PHARMACEUTICALS AMERICA, INC.]	5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
64764-123	OSENI (ALOGLIPTIN AND PIOGLITAZONE) TABLET, FILM COATED [TAKEDA PHARMACEUTICALS AMERICA, INC.]	23	Current NDC, Legacy NDC, 3 package rows	20250322_4c619ed9-fe3e-4158-9938-80c6c3493d55.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.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Alogliptin and Pioglitazone	ALOGLIPTIN BENZOATE AND PIOGLITAZONE HYDROCHLORIDE	Padagis Israel Pharmaceuticals Ltd	642b1e90-701e-42f2-bac6-a4918738e2c9	2025-07-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 022426 application number: NDA022426
OSENI	ALOGLIPTIN AND PIOGLITAZONE	Takeda Pharmaceuticals America, Inc.	4c619ed9-fe3e-4158-9938-80c6c3493d55	2025-02-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 022426 application number: NDA022426 ndc (product): 64764-123

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
EEN99869SC	ALOGLIPTIN BENZOATE	850649-62-6	ALOGLIPTIN BENZOATE
JQT35NPK6C	PIOGLITAZONE HYDROCHLORIDE	112529-15-4	PIOGLITAZONE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1368410	alogliptin 12.5 MG / pioglitazone 30 MG Oral Tablet	PSN	4c619ed9-fe3e-4158-9938-80c6c3493d55	23
1368424	alogliptin 25 MG / pioglitazone 15 MG Oral Tablet	PSN	4c619ed9-fe3e-4158-9938-80c6c3493d55	23
1368431	alogliptin 25 MG / pioglitazone 30 MG Oral Tablet	PSN	4c619ed9-fe3e-4158-9938-80c6c3493d55	23
1368438	alogliptin 25 MG / pioglitazone 45 MG Oral Tablet	PSN	4c619ed9-fe3e-4158-9938-80c6c3493d55	23
1368416	Oseni 12.5 MG / 30 MG Oral Tablet	PSN	4c619ed9-fe3e-4158-9938-80c6c3493d55	23
1368430	Oseni 25 MG / 15 MG Oral Tablet	PSN	4c619ed9-fe3e-4158-9938-80c6c3493d55	23
1368437	Oseni 25 MG / 30 MG Oral Tablet	PSN	4c619ed9-fe3e-4158-9938-80c6c3493d55	23
1368444	Oseni 25 MG / 45 MG Oral Tablet	PSN	4c619ed9-fe3e-4158-9938-80c6c3493d55	23
1368416	alogliptin 12.5 MG / pioglitazone 30 MG Oral Tablet [Oseni]	SBD	4c619ed9-fe3e-4158-9938-80c6c3493d55	23
1368430	alogliptin 25 MG / pioglitazone 15 MG Oral Tablet [Oseni]	SBD	4c619ed9-fe3e-4158-9938-80c6c3493d55	23
1368437	alogliptin 25 MG / pioglitazone 30 MG Oral Tablet [Oseni]	SBD	4c619ed9-fe3e-4158-9938-80c6c3493d55	23
1368444	alogliptin 25 MG / pioglitazone 45 MG Oral Tablet [Oseni]	SBD	4c619ed9-fe3e-4158-9938-80c6c3493d55	23
1368410	alogliptin 12.5 MG / pioglitazone 30 MG Oral Tablet	SCD	4c619ed9-fe3e-4158-9938-80c6c3493d55	23
1368424	alogliptin 25 MG / pioglitazone 15 MG Oral Tablet	SCD	4c619ed9-fe3e-4158-9938-80c6c3493d55	23
1368431	alogliptin 25 MG / pioglitazone 30 MG Oral Tablet	SCD	4c619ed9-fe3e-4158-9938-80c6c3493d55	23
1368438	alogliptin 25 MG / pioglitazone 45 MG Oral Tablet	SCD	4c619ed9-fe3e-4158-9938-80c6c3493d55	23
1368410	alogliptin 12.5 MG (as alogliptin benzoate 17 MG) / pioglitazone 30 MG (as pioglitazone hydrochloride 33.06 MG) Oral Tablet	SY	4c619ed9-fe3e-4158-9938-80c6c3493d55	23
1368424	alogliptin 25 MG (as alogliptin benzoate 34 MG) / pioglitazone 15 MG (as pioglitazone hydrochloride 16.53 MG) Oral Tablet	SY	4c619ed9-fe3e-4158-9938-80c6c3493d55	23
1368431	alogliptin 25 MG (as alogliptin benzoate 34 MG) / pioglitazone 30 MG (as pioglitazone hydrochloride 33.06 MG) Oral Tablet	SY	4c619ed9-fe3e-4158-9938-80c6c3493d55	23
1368438	alogliptin 25 MG (as alogliptin benzoate 34 MG) / pioglitazone 45 MG (as pioglitazone hydrochloride 49.59 MG) Oral Tablet	SY	4c619ed9-fe3e-4158-9938-80c6c3493d55	23
1368416	Oseni 12.5/30 (as alogliptin benzoate 17 MG / pioglitazone hydrochloride 33.06 MG) Oral Tablet	SY	4c619ed9-fe3e-4158-9938-80c6c3493d55	23
1368416	Oseni 12.5/30 Oral Tablet	SY	4c619ed9-fe3e-4158-9938-80c6c3493d55	23
1368430	Oseni 25/15 (as alogliptin benzoate 34 MG / pioglitazone hydrochloride 16.53 MG) Oral Tablet	SY	4c619ed9-fe3e-4158-9938-80c6c3493d55	23
1368430	Oseni 25/15 Oral Tablet	SY	4c619ed9-fe3e-4158-9938-80c6c3493d55	23
1368437	Oseni 25/30 (as alogliptin benzoate 34 MG / pioglitazone hydrochloride 33.06 MG) Oral Tablet	SY	4c619ed9-fe3e-4158-9938-80c6c3493d55	23
1368437	Oseni 25/30 Oral Tablet	SY	4c619ed9-fe3e-4158-9938-80c6c3493d55	23
1368444	Oseni 25/45 (as alogliptin benzoate 34 MG / pioglitazone hydrochloride 49.59 MG) Oral Tablet	SY	4c619ed9-fe3e-4158-9938-80c6c3493d55	23
1368444	Oseni 25/45 Oral Tablet	SY	4c619ed9-fe3e-4158-9938-80c6c3493d55	23

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
64764-123-03	64764012303	30 TABLET, FILM COATED in 1 BOTTLE (64764-123-03)	2013-01-25	0000-00-00	No	No	Current
64764-123-04	64764012304	90 TABLET, FILM COATED in 1 BOTTLE (64764-123-04)	2013-01-25	0000-00-00	No	No	Current
64764-123-05	64764012305	500 TABLET, FILM COATED in 1 BOTTLE (64764-123-05)	2013-01-25	0000-00-00	No	No	Current