Home NDC 64842-0727 INQOVI
Product NDC 64842-0727
11-digit product format 648420727
Labeler code 64842
Product ID 64842-0727_12a04358-38a6-4d9d-965b-de70660f9ed0
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name CEDAZURIDINE and DECITABINE
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Taiho Pharmaceutical Co., Ltd.
Application NDA212576
Marketing category NDA
Marketing start 2020-07-07
Substance CEDAZURIDINE; DECITABINE
Active strength 100; 35 mg/1; mg/1
Pharmacologic classes Nucleic Acid Synthesis Inhibitors [MoA], Nucleoside Metabolic Inhibitor [EPC]
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 42 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N212576-001 INQOVI CEDAZURIDINE; DECITABINE 100MG;35MG TABLET / ORAL RLD, RS 2020-07-07
Orange Book patents# Current patent rows page 1 of 1 · 11 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N212576-001 8618075 2028-10-16 U-2864 2020-08-05 N212576-001 8618075 2028-10-16 U-2867 2020-08-05 N212576-001 9567363 2028-10-16 Drug substance 2020-08-05 N212576-001 8268800 2030-08-22 U-2864 Drug substance 2020-08-05 N212576-001 8268800 2030-08-22 U-2865 Drug substance 2020-08-05 N212576-001 8268800 2030-08-22 U-2866 Drug substance 2020-08-05 N212576-001 8268800 2030-08-22 U-2867 Drug substance 2020-08-05 N212576-001 12195496 2040-10-07 Drug product 2025-02-07 N212576-001 11963971 2041-02-24 Drug product 2024-05-10 N212576-001 12239653 2041-02-24 U-2865 2025-03-27 N212576-001 12239653 2041-02-24 U-2866 2025-03-27
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 2 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N212576-001 ODE-316 2027-07-07 N212576-001 I-990 2029-05-13
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.
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 2026-08-18 06:07:40 2026-07 N212576-001 INQOVI 100MG;35MG TABLET / ORAL RLD, RS 2020-07-07 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N212576-001 INQOVI 100MG;35MG TABLET / ORAL RLD, RS 2020-07-07 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N212576-001 INQOVI 100MG;35MG TABLET / ORAL RLD, RS 2020-07-07 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N212576-001 INQOVI 100MG;35MG TABLET / ORAL RLD, RS 2020-07-07 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N212576-001 INQOVI 100MG;35MG TABLET / ORAL RLD, RS 2020-07-07 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N212576-001 INQOVI 100MG;35MG TABLET / ORAL RLD, RS 2020-07-07 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N212576-001 INQOVI 100MG;35MG TABLET / ORAL RLD, RS 2020-07-07 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N212576-001 INQOVI 100MG;35MG TABLET / ORAL RLD, RS 2020-07-07 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N212576-001 INQOVI 100MG;35MG TABLET / ORAL RLD, RS 2020-07-07 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N212576-001 INQOVI 100MG;35MG TABLET / ORAL RLD, RS 2020-07-07 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N212576-001 INQOVI 100MG;35MG TABLET / ORAL RLD, RS 2020-07-07 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N212576-001 INQOVI 100MG;35MG TABLET / ORAL RLD, RS 2020-07-07 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N212576-001 INQOVI 100MG;35MG TABLET / ORAL RLD, RS 2020-07-07 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N212576-001 INQOVI 100MG;35MG TABLET / ORAL RLD, RS 2020-07-07 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N212576-001 INQOVI 100MG;35MG TABLET / ORAL RLD, RS 2020-07-07 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N212576-001 INQOVI 100MG;35MG TABLET / ORAL RLD, RS 2020-07-07 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N212576-001 INQOVI 100MG;35MG TABLET / ORAL RLD, RS 2020-07-07 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N212576-001 INQOVI 100MG;35MG TABLET / ORAL RLD, RS 2020-07-07 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 N212576-001 INQOVI 100MG;35MG TABLET / ORAL RLD, RS 2020-07-07 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N212576-001 INQOVI 100MG;35MG TABLET / ORAL RLD, RS 2020-07-07 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N212576-001 INQOVI 100MG;35MG TABLET / ORAL RLD, RS 2020-07-07 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N212576-001 INQOVI 100MG;35MG TABLET / ORAL RLD, RS 2020-07-07 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N212576-001 INQOVI 100MG;35MG TABLET / ORAL RLD, RS 2020-07-07 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N212576-001 INQOVI 100MG;35MG TABLET / ORAL RLD, RS 2020-07-07 c0c555d07b60…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N212576-001 INQOVI 100MG;35MG TABLET / ORAL RLD, RS 2020-07-07 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N212576-001 INQOVI 100MG;35MG TABLET / ORAL RLD, RS 2020-07-07 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N212576-001 INQOVI 100MG;35MG TABLET / ORAL RLD, RS 2020-07-07 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N212576-001 INQOVI 100MG;35MG TABLET / ORAL RLD, RS 2020-07-07 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N212576-001 INQOVI 100MG;35MG TABLET / ORAL RLD, RS 2020-07-07 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N212576-001 INQOVI 100MG;35MG TABLET / ORAL RLD, RS 2020-07-07 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N212576-001 INQOVI 100MG;35MG TABLET / ORAL RLD, RS 2020-07-07 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N212576-001 INQOVI 100MG;35MG TABLET / ORAL RLD, RS 2020-07-07 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N212576-001 INQOVI 100MG;35MG TABLET / ORAL RLD, RS 2020-07-07 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N212576-001 INQOVI 100MG;35MG TABLET / ORAL RLD, RS 2020-07-07 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N212576-001 INQOVI 100MG;35MG TABLET / ORAL RLD, RS 2020-07-07 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N212576-001 INQOVI 100MG;35MG TABLET / ORAL RLD, RS 2020-07-07 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N212576-001 INQOVI 100MG;35MG TABLET / ORAL RLD, RS 2020-07-07 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N212576-001 INQOVI 100MG;35MG TABLET / ORAL RLD, RS 2020-07-07 a50c72e98297…
Observed Orange Book patent history# Patent history page 1 of 8 · 298 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-08-18 06:07:40 2026-07 N212576-001 8618075 2028-10-16 U-2864 2020-08-05 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N212576-001 8618075 2028-10-16 U-2867 2020-08-05 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N212576-001 9567363 2028-10-16 Drug substance 2020-08-05 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N212576-001 8268800 2030-08-22 U-2866 Drug substance 2020-08-05 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N212576-001 8268800 2030-08-22 U-2865 Drug substance 2020-08-05 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N212576-001 8268800 2030-08-22 U-2864 Drug substance 2020-08-05 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N212576-001 8268800 2030-08-22 U-2867 Drug substance 2020-08-05 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N212576-001 12195496 2040-10-07 Drug product 2025-02-07 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N212576-001 11963971 2041-02-24 Drug product 2024-05-10 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N212576-001 12239653 2041-02-24 U-2865 2025-03-27 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N212576-001 12239653 2041-02-24 U-2866 2025-03-27 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N212576-001 8618075 2028-10-16 U-2864 2020-08-05 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212576-001 8618075 2028-10-16 U-2867 2020-08-05 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212576-001 9567363 2028-10-16 Drug substance 2020-08-05 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212576-001 8268800 2030-08-22 U-2866 Drug substance 2020-08-05 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212576-001 8268800 2030-08-22 U-2865 Drug substance 2020-08-05 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212576-001 8268800 2030-08-22 U-2864 Drug substance 2020-08-05 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212576-001 8268800 2030-08-22 U-2867 Drug substance 2020-08-05 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212576-001 12195496 2040-10-07 Drug product 2025-02-07 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212576-001 11963971 2041-02-24 Drug product 2024-05-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212576-001 12239653 2041-02-24 U-2865 2025-03-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212576-001 12239653 2041-02-24 U-2866 2025-03-27 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N212576-001 8618075 2028-10-16 U-2864 2020-08-05 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N212576-001 8618075 2028-10-16 U-2867 2020-08-05 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N212576-001 9567363 2028-10-16 Drug substance 2020-08-05 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N212576-001 8268800 2030-08-22 U-2866 Drug substance 2020-08-05 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N212576-001 8268800 2030-08-22 U-2865 Drug substance 2020-08-05 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N212576-001 8268800 2030-08-22 U-2864 Drug substance 2020-08-05 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N212576-001 8268800 2030-08-22 U-2867 Drug substance 2020-08-05 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N212576-001 12195496 2040-10-07 Drug product 2025-02-07 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N212576-001 11963971 2041-02-24 Drug product 2024-05-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N212576-001 12239653 2041-02-24 U-2865 2025-03-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N212576-001 12239653 2041-02-24 U-2866 2025-03-27 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N212576-001 8618075 2028-10-16 U-2864 2020-08-05 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N212576-001 8618075 2028-10-16 U-2867 2020-08-05 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N212576-001 9567363 2028-10-16 Drug substance 2020-08-05 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N212576-001 8268800 2030-08-22 U-2866 Drug substance 2020-08-05 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N212576-001 8268800 2030-08-22 U-2865 Drug substance 2020-08-05 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N212576-001 8268800 2030-08-22 U-2864 Drug substance 2020-08-05 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N212576-001 8268800 2030-08-22 U-2867 Drug substance 2020-08-05 6a471c1ec25d…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 2 · 73 observed states.
Additional Listing Data#
Finished product Yes
Brand name base INQOVI
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CEDAZURIDINE 100 mg/1 DECITABINE 35 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 39IS23Q1EW Internal UNII lookup 776B62CQ27 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2384457 Internal RxNorm lookup 2384458 Internal RxNorm lookup 2384464 Internal RxNorm lookup 2384465 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 64842-0727-9 INQOVI 1 in 1 CARTON TABLET, FILM COATED 1 13 64842-0727-9 INQOVI 5 in 1 BLISTER PACK TABLET, FILM COATED 5 13
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 64842-0727 INQOVI (CEDAZURIDINE AND DECITABINE) TABLET, FILM COATED [TAIHO PHARMACEUTICAL CO., LTD.] 10 Current NDC, Legacy NDC, 2 package rows 20241206_91a0f80b-f865-4d06-a40d-4d148d99ee71.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 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join INQOVI CEDAZURIDINE AND DECITABINE Taiho Pharmaceutical Co., Ltd. 91a0f80b-f865-4d06-a40d-4d148d99ee71 2026-05-25 Warnings, Adverse reactions Exact identifier application applno (NDA): 212576 application number: NDA212576 ndc (product): 64842-0727
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 64842-0727-9 64842072709 1 BLISTER PACK in 1 CARTON (64842-0727-9) / 5 TABLET, FILM COATED in 1 BLISTER PACK 1 blister pack 2020-08-25 0000-00-00 No No Current