Nesina

Product NDC: 64764-250
11-digit product format: 647640250
Labeler code: 64764
Product ID: 64764-250_225103de-a3f2-47ee-bebb-4aa24b16aab4
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: alogliptin
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Takeda Pharmaceuticals America, Inc.
Application: NDA022271
Marketing category: NDA
Marketing start: 2013-01-25
Substance: ALOGLIPTIN BENZOATE
Active strength: 25 mg/1
Pharmacologic classes: Dipeptidyl Peptidase 4 Inhibitor [EPC], Dipeptidyl Peptidase 4 Inhibitors [MoA]
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 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N022271-001	NESINA	ALOGLIPTIN BENZOATE	EQ 6.25MG BASE	TABLET / ORAL	RLD	2013-01-25
N022271-002	NESINA	ALOGLIPTIN BENZOATE	EQ 12.5MG BASE	TABLET / ORAL	RLD	2013-01-25
N022271-003	NESINA	ALOGLIPTIN BENZOATE	EQ 25MG BASE	TABLET / ORAL	RLD, RS	2013-01-25

Orange Book patents#

Current patent rows page 1 of 1 · 6 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N022271-001	7807689	2028-06-27	U-1337	Drug substance, Drug product
N022271-001	8697125	2029-06-16		Drug product	2014-05-27
N022271-002	7807689	2028-06-27	U-1337	Drug substance, Drug product
N022271-002	8697125	2029-06-16		Drug product	2014-05-27
N022271-003	7807689	2028-06-27	U-1337	Drug substance, Drug product
N022271-003	8697125	2029-06-16		Drug product	2014-05-27

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 3 matching rows.

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N022271-001	M-300	2026-07-27
N022271-002	M-300	2026-07-27
N022271-003	M-300	2026-07-27

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 4 · 123 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	N022271-001	NESINA	EQ 6.25MG BASE	TABLET / ORAL	RLD	2013-01-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022271-002	NESINA	EQ 12.5MG BASE	TABLET / ORAL	RLD	2013-01-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022271-003	NESINA	EQ 25MG BASE	TABLET / ORAL	RLD, RS	2013-01-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022271-001	NESINA	EQ 6.25MG BASE	TABLET / ORAL	RLD	2013-01-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022271-002	NESINA	EQ 12.5MG BASE	TABLET / ORAL	RLD	2013-01-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022271-003	NESINA	EQ 25MG BASE	TABLET / ORAL	RLD, RS	2013-01-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022271-001	NESINA	EQ 6.25MG BASE	TABLET / ORAL	RLD	2013-01-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022271-002	NESINA	EQ 12.5MG BASE	TABLET / ORAL	RLD	2013-01-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022271-003	NESINA	EQ 25MG BASE	TABLET / ORAL	RLD, RS	2013-01-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022271-001	NESINA	EQ 6.25MG BASE	TABLET / ORAL	RLD	2013-01-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022271-002	NESINA	EQ 12.5MG BASE	TABLET / ORAL	RLD	2013-01-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022271-003	NESINA	EQ 25MG BASE	TABLET / ORAL	RLD, RS	2013-01-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022271-001	NESINA	EQ 6.25MG BASE	TABLET / ORAL	RLD	2013-01-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022271-002	NESINA	EQ 12.5MG BASE	TABLET / ORAL	RLD	2013-01-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022271-003	NESINA	EQ 25MG BASE	TABLET / ORAL	RLD, RS	2013-01-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022271-001	NESINA	EQ 6.25MG BASE	TABLET / ORAL	RLD	2013-01-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022271-002	NESINA	EQ 12.5MG BASE	TABLET / ORAL	RLD	2013-01-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022271-003	NESINA	EQ 25MG BASE	TABLET / ORAL	RLD, RS	2013-01-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022271-001	NESINA	EQ 6.25MG BASE	TABLET / ORAL	RLD	2013-01-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022271-002	NESINA	EQ 12.5MG BASE	TABLET / ORAL	RLD	2013-01-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022271-003	NESINA	EQ 25MG BASE	TABLET / ORAL	RLD, RS	2013-01-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022271-001	NESINA	EQ 6.25MG BASE	TABLET / ORAL	RLD	2013-01-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022271-002	NESINA	EQ 12.5MG BASE	TABLET / ORAL	RLD	2013-01-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022271-003	NESINA	EQ 25MG BASE	TABLET / ORAL	RLD, RS	2013-01-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022271-001	NESINA	EQ 6.25MG BASE	TABLET / ORAL	RLD	2013-01-25	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022271-002	NESINA	EQ 12.5MG BASE	TABLET / ORAL	RLD	2013-01-25	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022271-003	NESINA	EQ 25MG BASE	TABLET / ORAL	RLD, RS	2013-01-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022271-001	NESINA	EQ 6.25MG BASE	TABLET / ORAL	RLD	2013-01-25	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022271-002	NESINA	EQ 12.5MG BASE	TABLET / ORAL	RLD	2013-01-25	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022271-003	NESINA	EQ 25MG BASE	TABLET / ORAL	RLD, RS	2013-01-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022271-001	NESINA	EQ 6.25MG BASE	TABLET / ORAL	RLD	2013-01-25	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022271-002	NESINA	EQ 12.5MG BASE	TABLET / ORAL	RLD	2013-01-25	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022271-003	NESINA	EQ 25MG BASE	TABLET / ORAL	RLD, RS	2013-01-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022271-001	NESINA	EQ 6.25MG BASE	TABLET / ORAL	RLD	2013-01-25	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022271-002	NESINA	EQ 12.5MG BASE	TABLET / ORAL	RLD	2013-01-25	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022271-003	NESINA	EQ 25MG BASE	TABLET / ORAL	RLD, RS	2013-01-25	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022271-001	NESINA	EQ 6.25MG BASE	TABLET / ORAL	RLD	2013-01-25	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022271-002	NESINA	EQ 12.5MG BASE	TABLET / ORAL	RLD	2013-01-25	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022271-003	NESINA	EQ 25MG BASE	TABLET / ORAL	RLD, RS	2013-01-25	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022271-001	NESINA	EQ 6.25MG BASE	TABLET / ORAL	RLD	2013-01-25	`8072bd15b7f6…`

Observed Orange Book patent history#

Patent history page 1 of 13 · 516 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	N022271-001	7807689	2028-06-27	U-1337	Drug substance, Drug product		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022271-001	8697125	2029-06-16		Drug product	2014-05-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022271-002	7807689	2028-06-27	U-1337	Drug substance, Drug product		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022271-002	8697125	2029-06-16		Drug product	2014-05-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022271-003	7807689	2028-06-27	U-1337	Drug substance, Drug product		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022271-003	8697125	2029-06-16		Drug product	2014-05-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022271-001	8288539	2025-03-15		Drug substance		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022271-001	8173663	2025-12-02	U-1338		2017-01-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022271-001	7807689	2028-06-27	U-1337	Drug substance, Drug product		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022271-001	8697125	2029-06-16		Drug product	2014-05-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022271-002	8288539	2025-03-15		Drug substance		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022271-002	8173663	2025-12-02	U-1338		2017-01-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022271-002	7807689	2028-06-27	U-1337	Drug substance, Drug product		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022271-002	8697125	2029-06-16		Drug product	2014-05-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022271-003	8288539	2025-03-15		Drug substance		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022271-003	8173663	2025-12-02	U-1338		2017-01-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022271-003	7807689	2028-06-27	U-1337	Drug substance, Drug product		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022271-003	8697125	2029-06-16		Drug product	2014-05-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022271-001	8288539	2025-03-15		Drug substance		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022271-001	8173663	2025-12-02	U-1338		2017-01-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022271-001	7807689	2028-06-27	U-1337	Drug substance, Drug product		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022271-001	8697125	2029-06-16		Drug product	2014-05-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022271-002	8288539	2025-03-15		Drug substance		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022271-002	8173663	2025-12-02	U-1338		2017-01-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022271-002	7807689	2028-06-27	U-1337	Drug substance, Drug product		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022271-002	8697125	2029-06-16		Drug product	2014-05-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022271-003	8288539	2025-03-15		Drug substance		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022271-003	8173663	2025-12-02	U-1338		2017-01-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022271-003	7807689	2028-06-27	U-1337	Drug substance, Drug product		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022271-003	8697125	2029-06-16		Drug product	2014-05-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022271-001	8288539	2025-03-15		Drug substance		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022271-001	8173663	2025-12-02	U-1338		2017-01-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022271-001	7807689	2028-06-27	U-1337	Drug substance, Drug product		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022271-001	8697125	2029-06-16		Drug product	2014-05-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022271-002	8288539	2025-03-15		Drug substance		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022271-002	8173663	2025-12-02	U-1338		2017-01-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022271-002	7807689	2028-06-27	U-1337	Drug substance, Drug product		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022271-002	8697125	2029-06-16		Drug product	2014-05-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022271-003	8288539	2025-03-15		Drug substance		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022271-003	8173663	2025-12-02	U-1338		2017-01-19	`fd3edfee7708…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 2 · 72 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N022271-001	M-300	2026-07-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022271-002	M-300	2026-07-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022271-003	M-300	2026-07-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022271-001	M-300	2026-07-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022271-002	M-300	2026-07-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022271-003	M-300	2026-07-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022271-001	M-300	2026-07-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022271-002	M-300	2026-07-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022271-003	M-300	2026-07-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022271-001	M-300	2026-07-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022271-002	M-300	2026-07-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022271-003	M-300	2026-07-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022271-001	M-300	2026-07-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022271-002	M-300	2026-07-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022271-003	M-300	2026-07-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022271-001	M-300	2026-07-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022271-002	M-300	2026-07-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022271-003	M-300	2026-07-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022271-001	M-300	2026-07-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022271-002	M-300	2026-07-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022271-003	M-300	2026-07-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022271-001	M-300	2026-07-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022271-002	M-300	2026-07-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022271-003	M-300	2026-07-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022271-001	M-300	2026-07-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022271-002	M-300	2026-07-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022271-003	M-300	2026-07-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022271-001	M-300	2026-07-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022271-002	M-300	2026-07-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022271-003	M-300	2026-07-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022271-001	M-300	2026-07-27	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022271-002	M-300	2026-07-27	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022271-003	M-300	2026-07-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022271-001	M-300	2026-07-27	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022271-002	M-300	2026-07-27	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022271-003	M-300	2026-07-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022271-001	M-300	2026-07-27	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022271-002	M-300	2026-07-27	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022271-003	M-300	2026-07-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022271-001	M-300	2026-07-27	`8072bd15b7f6…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ALOGLIPTIN BENZOATE	25 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

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

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 6 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1368006	Internal RxNorm lookup
1368012	Internal RxNorm lookup
1368018	Internal RxNorm lookup
1368020	Internal RxNorm lookup
1368034	Internal RxNorm lookup
1368036	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
a3768c7e-aa4c-44d3-bc53-43bb7346c0b0	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
36db81cb-9c11-39e1-6a1a-715fc2caa47c	Product name	1	20140508
ac29cd77-922c-d25a-f8ad-66a8692935c5	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
64764-250-02	Nesina	4 in 1 TRAY	TABLET, FILM COATED	4	22
64764-250-02	Nesina	1 in 1 CARTON	TABLET, FILM COATED	1	22
64764-250-30	Nesina	30 in 1 BOTTLE	TABLET, FILM COATED	30	22
64764-250-50	Nesina	500 in 1 BOTTLE	TABLET, FILM COATED	500	22
64764-250-90	Nesina	90 in 1 BOTTLE	TABLET, FILM COATED	90	22

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
64764-250-30	EA - Each	64764-250	ce297a6d-a4b3-4342-822f-c1fd34fc65b1	1	2013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ALOGLIPTIN BENZOATE	ACTIVE INGREDIENT	EEN99869SC	NESINA (ALOGLIPTIN) TABLET, FILM COATED [TAKEDA PHARMACEUTICALS AMERICA, INC.]	6
ALOGLIPTIN	ACTIVE MOIETY	JHC049LO86	NESINA (ALOGLIPTIN) TABLET, FILM COATED [TAKEDA PHARMACEUTICALS AMERICA, INC.]	6
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	NESINA (ALOGLIPTIN) TABLET, FILM COATED [TAKEDA PHARMACEUTICALS AMERICA, INC.]	6
BUTYL ALCOHOL	INACTIVE INGREDIENT	8PJ61P6TS3	NESINA (ALOGLIPTIN) TABLET, FILM COATED [TAKEDA PHARMACEUTICALS AMERICA, INC.]	6
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	NESINA (ALOGLIPTIN) TABLET, FILM COATED [TAKEDA PHARMACEUTICALS AMERICA, INC.]	6
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	NESINA (ALOGLIPTIN) TABLET, FILM COATED [TAKEDA PHARMACEUTICALS AMERICA, INC.]	6
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	NESINA (ALOGLIPTIN) TABLET, FILM COATED [TAKEDA PHARMACEUTICALS AMERICA, INC.]	6
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	NESINA (ALOGLIPTIN) TABLET, FILM COATED [TAKEDA PHARMACEUTICALS AMERICA, INC.]	6
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	NESINA (ALOGLIPTIN) TABLET, FILM COATED [TAKEDA PHARMACEUTICALS AMERICA, INC.]	6
HYDROXYPROPYL CELLULOSE (TYPE L)	INACTIVE INGREDIENT	UKE75GEA7F	NESINA (ALOGLIPTIN) TABLET, FILM COATED [TAKEDA PHARMACEUTICALS AMERICA, INC.]	6
HYPROMELLOSE 2910 (6 MPA.S)	INACTIVE INGREDIENT	0WZ8WG20P6	NESINA (ALOGLIPTIN) TABLET, FILM COATED [TAKEDA PHARMACEUTICALS AMERICA, INC.]	6
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	NESINA (ALOGLIPTIN) TABLET, FILM COATED [TAKEDA PHARMACEUTICALS AMERICA, INC.]	6
MANNITOL	INACTIVE INGREDIENT	3OWL53L36A	NESINA (ALOGLIPTIN) TABLET, FILM COATED [TAKEDA PHARMACEUTICALS AMERICA, INC.]	6
POLYETHYLENE GLYCOL 8000	INACTIVE INGREDIENT	Q662QK8M3B	NESINA (ALOGLIPTIN) TABLET, FILM COATED [TAKEDA PHARMACEUTICALS AMERICA, INC.]	6
SHELLAC	INACTIVE INGREDIENT	46N107B71O	NESINA (ALOGLIPTIN) TABLET, FILM COATED [TAKEDA PHARMACEUTICALS AMERICA, INC.]	6
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	NESINA (ALOGLIPTIN) TABLET, FILM COATED [TAKEDA PHARMACEUTICALS AMERICA, INC.]	6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
64764-250	NESINA (ALOGLIPTIN) TABLET, FILM COATED [TAKEDA PHARMACEUTICALS AMERICA, INC.]	22	Current NDC, Legacy NDC, 5 package rows	20250322_a3768c7e-aa4c-44d3-bc53-43bb7346c0b0.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 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Alogliptin	ALOGLIPTIN	Padagis Israel Pharmaceuticals Ltd	b25f155a-1259-47c2-aa3b-7c1356e4c7f6	2025-04-11	Warnings, Adverse reactions	Exact identifier application applno (NDA): 022271 application number: NDA022271
Nesina	ALOGLIPTIN	Takeda Pharmaceuticals America, Inc.	a3768c7e-aa4c-44d3-bc53-43bb7346c0b0	2025-02-28	Warnings, Adverse reactions	Exact identifier application applno (NDA): 022271 application number: NDA022271 ndc (product): 64764-250
Alogliptin	ALOGLIPTIN	Bryant Ranch Prepack	f2ad6d21-8060-42c7-8b3f-ad80085dc022	2025-01-28	Warnings, Adverse reactions	Exact identifier application applno (NDA): 022271 application number: NDA022271
Alogliptin	ALOGLIPTIN	A-S Medication Solutions	38d30e4f-4212-4f7a-96b5-74b277b56cba	2023-10-24	Warnings, Adverse reactions	Exact identifier application applno (NDA): 022271 application number: NDA022271
Alogliptin	ALOGLIPTIN	Aphena Pharma Solutions - Tennessee, LLC	4b007011-547a-498e-b8f6-34ea4ea00eb4	2023-02-02	Warnings, Adverse reactions	Exact identifier application applno (NDA): 022271 application number: NDA022271
Alogliptin	ALOGLIPTIN	Aphena Pharma Solutions - Tennessee, LLC	a05d6d17-79f9-4788-a4d5-467bca1a2d91	2022-10-18	Warnings, Adverse reactions	Exact identifier application applno (NDA): 022271 application number: NDA022271

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
EEN99869SC	ALOGLIPTIN BENZOATE	850649-62-6	ALOGLIPTIN BENZOATE
JHC049LO86	ALOGLIPTIN	850649-61-5	alogliptin

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1368034	alogliptin 12.5 MG Oral Tablet	PSN	a3768c7e-aa4c-44d3-bc53-43bb7346c0b0	22
1368006	alogliptin 25 MG Oral Tablet	PSN	a3768c7e-aa4c-44d3-bc53-43bb7346c0b0	22
1368018	alogliptin 6.25 MG Oral Tablet	PSN	a3768c7e-aa4c-44d3-bc53-43bb7346c0b0	22
1368036	Nesina 12.5 MG Oral Tablet	PSN	a3768c7e-aa4c-44d3-bc53-43bb7346c0b0	22
1368012	Nesina 25 MG Oral Tablet	PSN	a3768c7e-aa4c-44d3-bc53-43bb7346c0b0	22
1368020	Nesina 6.25 MG Oral Tablet	PSN	a3768c7e-aa4c-44d3-bc53-43bb7346c0b0	22
1368036	alogliptin 12.5 MG Oral Tablet [Nesina]	SBD	a3768c7e-aa4c-44d3-bc53-43bb7346c0b0	22
1368012	alogliptin 25 MG Oral Tablet [Nesina]	SBD	a3768c7e-aa4c-44d3-bc53-43bb7346c0b0	22
1368020	alogliptin 6.25 MG Oral Tablet [Nesina]	SBD	a3768c7e-aa4c-44d3-bc53-43bb7346c0b0	22
1368034	alogliptin 12.5 MG Oral Tablet	SCD	a3768c7e-aa4c-44d3-bc53-43bb7346c0b0	22
1368006	alogliptin 25 MG Oral Tablet	SCD	a3768c7e-aa4c-44d3-bc53-43bb7346c0b0	22
1368018	alogliptin 6.25 MG Oral Tablet	SCD	a3768c7e-aa4c-44d3-bc53-43bb7346c0b0	22
1368034	alogliptin 12.5 MG (as alogliptin benzoate 17 MG) Oral Tablet	SY	a3768c7e-aa4c-44d3-bc53-43bb7346c0b0	22
1368006	alogliptin 25 MG (as alogliptin benzoate 34 MG) Oral Tablet	SY	a3768c7e-aa4c-44d3-bc53-43bb7346c0b0	22
1368018	alogliptin 6.25 MG (as alogliptin benzoate 8.5 MG) Oral Tablet	SY	a3768c7e-aa4c-44d3-bc53-43bb7346c0b0	22
1368036	Nesina 12.5 MG (as alogliptin benzoate 17 MG) Oral Tablet	SY	a3768c7e-aa4c-44d3-bc53-43bb7346c0b0	22
1368036	Nesina 12.5 MG Oral Tablet	SY	a3768c7e-aa4c-44d3-bc53-43bb7346c0b0	22
1368012	Nesina 25 MG (as alogliptin benzoate 34 MG) Oral Tablet	SY	a3768c7e-aa4c-44d3-bc53-43bb7346c0b0	22
1368012	Nesina 25 MG Oral Tablet	SY	a3768c7e-aa4c-44d3-bc53-43bb7346c0b0	22
1368020	Nesina 6.25 MG (as alogliptin benzoate 8.5 MG) Oral Tablet	SY	a3768c7e-aa4c-44d3-bc53-43bb7346c0b0	22
1368020	Nesina 6.25 MG Oral Tablet	SY	a3768c7e-aa4c-44d3-bc53-43bb7346c0b0	22

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
64764-250-02	64764025002	4 CARTON in 1 TRAY (64764-250-02) / 1 BLISTER PACK in 1 CARTON / 7 TABLET, FILM COATED in 1 BLISTER PACK	4 carton	2013-01-25	0000-00-00	No	No	Current
64764-250-30	64764025030	30 TABLET, FILM COATED in 1 BOTTLE (64764-250-30)		2013-01-25	0000-00-00	No	No	Current
64764-250-50	64764025050	500 TABLET, FILM COATED in 1 BOTTLE (64764-250-50)		2013-01-25	0000-00-00	No	No	Current
64764-250-90	64764025090	90 TABLET, FILM COATED in 1 BOTTLE (64764-250-90)		2013-01-25	0000-00-00	No	No	Current