Home DailyMed 8e6c76e5-ba7d-4353-a222-64d4a2b76fef National Council for Prescription Drug Programs indexing - billing unit Drug label information. FDA.report displays public Structured Product Labeling data from DailyMed and legacy FDA.report DailyMed cache rows. This page is not medical advice, prescribing advice, or a substitute for the official label reviewed by a qualified healthcare professional. Labeling can change; when a current hydrated DailyMed SPL record is available, FDA.report shows that newer record before legacy cached files.
Manufacturer National Council for Prescription Drug Programs
Effective date 2013-02-13
Label type Indexing - Billing Unit
Version 1
Source full-release
Hydrated at 2026-06-05 03:17:43 Orange Book application contexts# All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.
Orange Book application contexts page 1 of 1 · 1 matching rows.
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 · 86 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 2026-09-14 22:38:34 2026-08 N203414-001 KAZANO EQ 12.5MG BASE;500MG TABLET / ORAL RLD 2013-01-25 84e616aacf4f…2026-09-14 22:38:34 2026-08 N203414-002 KAZANO EQ 12.5MG BASE;1GM TABLET / ORAL RLD, RS 2013-01-25 84e616aacf4f…2026-08-18 06:07:40 2026-07 N203414-001 KAZANO EQ 12.5MG BASE;500MG TABLET / ORAL RLD 2013-01-25 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N203414-002 KAZANO EQ 12.5MG BASE;1GM TABLET / ORAL RLD, RS 2013-01-25 caaa826d4ba7…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…
Observed Orange Book patent history# Patent history page 1 of 9 · 352 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-09-14 22:38:34 2026-08 N203414-001 7807689 2028-06-27 U-1337 Drug substance, Drug product 84e616aacf4f…2026-09-14 22:38:34 2026-08 N203414-001 8900638 2029-05-24 Drug product 2014-12-18 84e616aacf4f…2026-09-14 22:38:34 2026-08 N203414-002 7807689 2028-06-27 U-1337 Drug substance, Drug product 84e616aacf4f…2026-09-14 22:38:34 2026-08 N203414-002 8900638 2029-05-24 Drug product 2014-12-18 84e616aacf4f…2026-08-18 06:07:40 2026-07 N203414-001 7807689 2028-06-27 U-1337 Drug substance, Drug product caaa826d4ba7…2026-08-18 06:07:40 2026-07 N203414-001 8900638 2029-05-24 Drug product 2014-12-18 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N203414-002 7807689 2028-06-27 U-1337 Drug substance, Drug product caaa826d4ba7…2026-08-18 06:07:40 2026-07 N203414-002 8900638 2029-05-24 Drug product 2014-12-18 caaa826d4ba7…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…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 2 · 52 observed states.
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 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join KAZANO ALOGLIPTIN AND METFORMIN HYDROCHLORIDE Takeda Pharmaceuticals America, Inc. 83cb7914-a683-47bb-a713-f2bc6a596bd2 2026-08-17 Boxed warning, Warnings, Adverse reactions Exact identifier ndc (package): 64764-335-60 ndc11 (package): 64764033560
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.