Home NDC 71610-300 Alogliptin
Product NDC 71610-300
11-digit product format 716100300
Labeler code 71610
Product ID 71610-300_a8ff5402-3a49-4f04-9868-f8b2dff3aa99
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Alogliptin
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Aphena Pharma Solutions - Tennessee, LLC
Application NDA022271
Marketing category NDA AUTHORIZED GENERIC
Marketing start 2016-04-08
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 TE codes 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 Product TE source text 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.
Additional Listing Data#
Finished product Yes
Brand name base Alogliptin
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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1368006 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 71610-300-09 Alogliptin 9000 in 1 BOTTLE TABLET, FILM COATED 9000 4 71610-300-18 Alogliptin 3000 in 1 BOTTLE TABLET, FILM COATED 3000 4 71610-300-60 Alogliptin 90 in 1 BOTTLE TABLET, FILM COATED 90 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 71610-300 ALOGLIPTIN TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 4 Current NDC, Legacy NDC, 3 package rows 20230203_4b007011-547a-498e-b8f6-34ea4ea00eb4.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 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 ndc (product): 71610-300 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
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 71610-300-09 71610030009 9000 TABLET, FILM COATED in 1 BOTTLE (71610-300-09) 2019-07-03 0000-00-00 No No Current 71610-300-18 71610030018 3000 TABLET, FILM COATED in 1 BOTTLE (71610-300-18) 2022-01-25 No No Current 71610-300-60 71610030060 90 TABLET, FILM COATED in 1 BOTTLE (71610-300-60) 2023-02-02 No No Current