OSENI

Product NDC: 64764-124
11-digit product format: 647640124
Labeler code: 64764
Product ID: 64764-124_ddffe5eb-c576-4c7f-89e7-0b20c7468d2f
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
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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	64764-124		D	Discontinued by firm	2026-08-10
excluded package	package	64764-124	64764-124-03	D	Discontinued by firm	2026-08-10
excluded package	package	64764-124	64764-124-04	D	Discontinued by firm	2026-08-10
excluded package	package	64764-124	64764-124-05	D	Discontinued by firm	2026-08-10

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 · 48 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	64764-124-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	64764-124-04	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	64764-124-03	`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	64764-124-05	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	64764-124-04	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	64764-124-03	`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	64764-124-05	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	64764-124-04	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	64764-124-03	`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	64764-124-05	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	64764-124-04	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	64764-124-03	`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	64764-124-05	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	64764-124-04	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	64764-124-03	`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	64764-124-05	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	64764-124-04	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	64764-124-03	`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	64764-124-05	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	64764-124-04	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	64764-124-03	`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	64764-124-05	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	64764-124-04	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	64764-124-03	`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	64764-124-05	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	64764-124-04	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	64764-124-03	`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	64764-124-05	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	64764-124-04	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	64764-124-03	`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	64764-124-05	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	64764-124-04	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	64764-124-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	64764-124-05	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	64764-124-04	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	64764-124-03	`557ba5c1ecfa…`	`9c80585c8c6e…`

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…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
64764-124-03	EA - Each	64764-124	c643ed33-e902-4dc5-8e40-934202846304	1	2013-02-13

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

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
64764-124-03	64764012403	30 TABLET, FILM COATED in 1 BOTTLE (64764-124-03)	2013-01-25	0000-00-00	No	No	Current
64764-124-04	64764012404	90 TABLET, FILM COATED in 1 BOTTLE (64764-124-04)	2013-01-25	0000-00-00	No	No	Current
64764-124-05	64764012405	500 TABLET, FILM COATED in 1 BOTTLE (64764-124-05)	2013-01-25	0000-00-00	No	No	Current