Home NDC 64764-335 KAZANO
Product NDC 64764-335
11-digit product format 647640335
Labeler code 64764
Product ID 64764-335_2179e953-e16e-4bfe-a36e-fce2da468f33
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name alogliptin and metformin hydrochloride
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Takeda Pharmaceuticals America, Inc.
Application NDA203414
Marketing category NDA
Marketing start 2013-01-25
Substance ALOGLIPTIN BENZOATE; METFORMIN HYDROCHLORIDE
Active strength 12.5; 500 mg/1; mg/1
Pharmacologic classes Biguanide [EPC], Biguanides [CS], 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 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N203414-001 KAZANO ALOGLIPTIN BENZOATE; METFORMIN HYDROCHLORIDE EQ 12.5MG BASE;500MG TABLET / ORAL RLD 2013-01-25 N203414-002 KAZANO ALOGLIPTIN BENZOATE; METFORMIN HYDROCHLORIDE EQ 12.5MG BASE;1GM TABLET / ORAL RLD, RS 2013-01-25
Orange Book patents# Current patent rows page 1 of 1 · 4 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N203414-001 7807689 2028-06-27 U-1337 Drug substance, Drug product N203414-001 8900638 2029-05-24 Drug product 2014-12-18 N203414-002 7807689 2028-06-27 U-1337 Drug substance, Drug product N203414-002 8900638 2029-05-24 Drug product 2014-12-18
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 2 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N203414-001 M-300 2026-07-27 N203414-002 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 3 · 82 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 N203414-001 KAZANO EQ 12.5MG BASE;500MG TABLET / ORAL RLD 2013-01-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N203414-002 KAZANO EQ 12.5MG BASE;1GM TABLET / ORAL RLD, RS 2013-01-25 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N203414-001 KAZANO EQ 12.5MG BASE;500MG TABLET / ORAL RLD 2013-01-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N203414-002 KAZANO EQ 12.5MG BASE;1GM TABLET / ORAL RLD, RS 2013-01-25 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N203414-001 KAZANO EQ 12.5MG BASE;500MG TABLET / ORAL RLD 2013-01-25 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N203414-002 KAZANO EQ 12.5MG BASE;1GM TABLET / ORAL RLD, RS 2013-01-25 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N203414-001 KAZANO EQ 12.5MG BASE;500MG TABLET / ORAL RLD 2013-01-25 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N203414-002 KAZANO EQ 12.5MG BASE;1GM TABLET / ORAL RLD, RS 2013-01-25 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N203414-001 KAZANO EQ 12.5MG BASE;500MG TABLET / ORAL RLD 2013-01-25 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N203414-002 KAZANO EQ 12.5MG BASE;1GM TABLET / ORAL RLD, RS 2013-01-25 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N203414-001 KAZANO EQ 12.5MG BASE;500MG TABLET / ORAL RLD 2013-01-25 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N203414-002 KAZANO EQ 12.5MG BASE;1GM TABLET / ORAL RLD, RS 2013-01-25 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N203414-001 KAZANO EQ 12.5MG BASE;500MG TABLET / ORAL RLD 2013-01-25 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N203414-002 KAZANO EQ 12.5MG BASE;1GM TABLET / ORAL RLD, RS 2013-01-25 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N203414-001 KAZANO EQ 12.5MG BASE;500MG TABLET / ORAL RLD 2013-01-25 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N203414-002 KAZANO EQ 12.5MG BASE;1GM TABLET / ORAL RLD, RS 2013-01-25 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N203414-001 KAZANO EQ 12.5MG BASE;500MG TABLET / ORAL RLD 2013-01-25 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N203414-002 KAZANO EQ 12.5MG BASE;1GM TABLET / ORAL RLD, RS 2013-01-25 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N203414-001 KAZANO EQ 12.5MG BASE;500MG TABLET / ORAL RLD 2013-01-25 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N203414-002 KAZANO EQ 12.5MG BASE;1GM TABLET / ORAL RLD, RS 2013-01-25 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N203414-001 KAZANO EQ 12.5MG BASE;500MG TABLET / ORAL RLD 2013-01-25 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N203414-002 KAZANO EQ 12.5MG BASE;1GM TABLET / ORAL RLD, RS 2013-01-25 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N203414-001 KAZANO EQ 12.5MG BASE;500MG TABLET / ORAL RLD 2013-01-25 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N203414-002 KAZANO EQ 12.5MG BASE;1GM TABLET / ORAL RLD, RS 2013-01-25 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N203414-001 KAZANO EQ 12.5MG BASE;500MG TABLET / ORAL RLD 2013-01-25 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N203414-002 KAZANO EQ 12.5MG BASE;1GM TABLET / ORAL RLD, RS 2013-01-25 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N203414-001 KAZANO EQ 12.5MG BASE;500MG TABLET / ORAL RLD 2013-01-25 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N203414-002 KAZANO EQ 12.5MG BASE;1GM TABLET / ORAL RLD, RS 2013-01-25 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N203414-001 KAZANO EQ 12.5MG BASE;500MG TABLET / ORAL RLD 2013-01-25 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N203414-002 KAZANO EQ 12.5MG BASE;1GM TABLET / ORAL RLD, RS 2013-01-25 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N203414-001 KAZANO EQ 12.5MG BASE;500MG TABLET / ORAL RLD 2013-01-25 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N203414-002 KAZANO EQ 12.5MG BASE;1GM TABLET / ORAL RLD, RS 2013-01-25 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N203414-001 KAZANO EQ 12.5MG BASE;500MG TABLET / ORAL RLD 2013-01-25 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N203414-002 KAZANO EQ 12.5MG BASE;1GM TABLET / ORAL RLD, RS 2013-01-25 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N203414-001 KAZANO EQ 12.5MG BASE;500MG TABLET / ORAL RLD 2013-01-25 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N203414-002 KAZANO EQ 12.5MG BASE;1GM TABLET / ORAL RLD, RS 2013-01-25 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N203414-001 KAZANO EQ 12.5MG BASE;500MG TABLET / ORAL RLD 2013-01-25 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N203414-002 KAZANO EQ 12.5MG BASE;1GM TABLET / ORAL RLD, RS 2013-01-25 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N203414-001 KAZANO EQ 12.5MG BASE;500MG TABLET / ORAL RLD 2013-01-25 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N203414-002 KAZANO EQ 12.5MG BASE;1GM TABLET / ORAL RLD, RS 2013-01-25 782e0a99824c…
Observed Orange Book patent history# Patent history page 1 of 9 · 344 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 N203414-001 7807689 2028-06-27 U-1337 Drug substance, Drug product 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N203414-001 8900638 2029-05-24 Drug product 2014-12-18 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N203414-002 7807689 2028-06-27 U-1337 Drug substance, Drug product 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N203414-002 8900638 2029-05-24 Drug product 2014-12-18 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N203414-001 8173663 2025-03-15 U-1338 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N203414-001 8288539 2025-06-24 Drug substance 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N203414-001 7807689 2028-06-27 U-1337 Drug substance, Drug product 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N203414-001 8900638 2029-05-24 Drug product 2014-12-18 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N203414-002 8173663 2025-03-15 U-1338 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N203414-002 8288539 2025-06-24 Drug substance 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N203414-002 7807689 2028-06-27 U-1337 Drug substance, Drug product 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N203414-002 8900638 2029-05-24 Drug product 2014-12-18 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N203414-001 8173663 2025-03-15 U-1338 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N203414-001 8288539 2025-06-24 Drug substance 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N203414-001 7807689 2028-06-27 U-1337 Drug substance, Drug product 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N203414-001 8900638 2029-05-24 Drug product 2014-12-18 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N203414-002 8173663 2025-03-15 U-1338 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N203414-002 8288539 2025-06-24 Drug substance 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N203414-002 7807689 2028-06-27 U-1337 Drug substance, Drug product 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N203414-002 8900638 2029-05-24 Drug product 2014-12-18 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N203414-001 8173663 2025-03-15 U-1338 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N203414-001 8288539 2025-06-24 Drug substance fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N203414-001 7807689 2028-06-27 U-1337 Drug substance, Drug product fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N203414-001 8900638 2029-05-24 Drug product 2014-12-18 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N203414-002 8173663 2025-03-15 U-1338 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N203414-002 8288539 2025-06-24 Drug substance fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N203414-002 7807689 2028-06-27 U-1337 Drug substance, Drug product fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N203414-002 8900638 2029-05-24 Drug product 2014-12-18 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N203414-001 8173663 2025-03-15 U-1338 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N203414-001 8288539 2025-06-24 Drug substance b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N203414-001 7807689 2028-06-27 U-1337 Drug substance, Drug product b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N203414-001 8900638 2029-05-24 Drug product 2014-12-18 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N203414-002 8173663 2025-03-15 U-1338 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N203414-002 8288539 2025-06-24 Drug substance b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N203414-002 7807689 2028-06-27 U-1337 Drug substance, Drug product b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N203414-002 8900638 2029-05-24 Drug product 2014-12-18 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N203414-001 8173663 2025-03-15 U-1338 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N203414-001 8288539 2025-06-24 Drug substance 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N203414-001 7807689 2028-06-27 U-1337 Drug substance, Drug product 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N203414-001 8900638 2029-05-24 Drug product 2014-12-18 03ed91905a0d…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 2 · 48 observed states.
Additional Listing Data#
Finished product Yes
Brand name base KAZANO
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ALOGLIPTIN BENZOATE 12.5 mg/1 METFORMIN HYDROCHLORIDE 500 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 786Z46389E Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1368385 Internal RxNorm lookup 1368391 Internal RxNorm lookup 1368392 Internal RxNorm lookup 1368398 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 64764-335-01 KAZANO 4 in 1 TRAY TABLET, FILM COATED 4 21 64764-335-01 KAZANO 1 in 1 CARTON TABLET, FILM COATED 1 21 64764-335-60 KAZANO 60 in 1 BOTTLE TABLET, FILM COATED 60 21 64764-335-77 KAZANO 500 in 1 BOTTLE TABLET, FILM COATED 500 21 64764-335-80 KAZANO 180 in 1 BOTTLE TABLET, FILM COATED 180 21
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded ALOGLIPTIN BENZOATE ACTIVE INGREDIENT EEN99869SC KAZANO (ALOGLIPTIN AND METFORMIN HYDROCHLORIDE) TABLET, FILM COATED [TAKEDA PHARMACEUTICALS AMERICA, INC.] 5 Metformin hydrochloride ACTIVE INGREDIENT 786Z46389E KAZANO (ALOGLIPTIN AND METFORMIN HYDROCHLORIDE) TABLET, FILM COATED [TAKEDA PHARMACEUTICALS AMERICA, INC.] 5 Alogliptin ACTIVE MOIETY JHC049LO86 KAZANO (ALOGLIPTIN AND METFORMIN HYDROCHLORIDE) TABLET, FILM COATED [TAKEDA PHARMACEUTICALS AMERICA, INC.] 5 Metformin ACTIVE MOIETY 9100L32L2N KAZANO (ALOGLIPTIN AND METFORMIN HYDROCHLORIDE) TABLET, FILM COATED [TAKEDA PHARMACEUTICALS AMERICA, INC.] 5 cellulose, microcrystalline INACTIVE INGREDIENT OP1R32D61U KAZANO (ALOGLIPTIN AND METFORMIN HYDROCHLORIDE) TABLET, FILM COATED [TAKEDA PHARMACEUTICALS AMERICA, INC.] 5 crospovidone INACTIVE INGREDIENT 68401960MK KAZANO (ALOGLIPTIN AND METFORMIN HYDROCHLORIDE) TABLET, FILM COATED [TAKEDA PHARMACEUTICALS AMERICA, INC.] 5 ferric oxide yellow INACTIVE INGREDIENT EX438O2MRT KAZANO (ALOGLIPTIN AND METFORMIN HYDROCHLORIDE) TABLET, FILM COATED [TAKEDA PHARMACEUTICALS AMERICA, INC.] 5 HYPROMELLOSE 2910 (6 MPA.S) INACTIVE INGREDIENT 0WZ8WG20P6 KAZANO (ALOGLIPTIN AND METFORMIN HYDROCHLORIDE) TABLET, FILM COATED [TAKEDA PHARMACEUTICALS AMERICA, INC.] 5 magnesium stearate INACTIVE INGREDIENT 70097M6I30 KAZANO (ALOGLIPTIN AND METFORMIN HYDROCHLORIDE) TABLET, FILM COATED [TAKEDA PHARMACEUTICALS AMERICA, INC.] 5 mannitol INACTIVE INGREDIENT 3OWL53L36A KAZANO (ALOGLIPTIN AND METFORMIN HYDROCHLORIDE) TABLET, FILM COATED [TAKEDA PHARMACEUTICALS AMERICA, INC.] 5 POVIDONES INACTIVE INGREDIENT FZ989GH94E KAZANO (ALOGLIPTIN AND METFORMIN HYDROCHLORIDE) TABLET, FILM COATED [TAKEDA PHARMACEUTICALS AMERICA, INC.] 5 talc INACTIVE INGREDIENT 7SEV7J4R1U KAZANO (ALOGLIPTIN AND METFORMIN HYDROCHLORIDE) TABLET, FILM COATED [TAKEDA PHARMACEUTICALS AMERICA, INC.] 5 titanium dioxide INACTIVE INGREDIENT 15FIX9V2JP KAZANO (ALOGLIPTIN AND METFORMIN HYDROCHLORIDE) 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 64764-335 KAZANO (ALOGLIPTIN AND METFORMIN HYDROCHLORIDE) TABLET, FILM COATED [TAKEDA PHARMACEUTICALS AMERICA, INC.] 20 Current NDC, Legacy NDC, 5 package rows 20250302_83cb7914-a683-47bb-a713-f2bc6a596bd2.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 · 3 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 64764-335-01 64764033501 4 CARTON in 1 TRAY (64764-335-01) / 1 BLISTER PACK in 1 CARTON / 14 TABLET, FILM COATED in 1 BLISTER PACK 4 carton 2013-01-25 0000-00-00 No No Current 64764-335-60 64764033560 60 TABLET, FILM COATED in 1 BOTTLE (64764-335-60) 2013-01-25 0000-00-00 No No Current 64764-335-77 64764033577 500 TABLET, FILM COATED in 1 BOTTLE (64764-335-77) 2013-01-25 0000-00-00 No No Current 64764-335-80 64764033580 180 TABLET, FILM COATED in 1 BOTTLE (64764-335-80) 2013-01-25 0000-00-00 No No Current