Home NDC 0469-0420 CRESEMBA
Product NDC 0469-0420
11-digit product format 004690420
Labeler code 0469
Product ID 0469-0420_7e6e45d4-9266-4451-b6b6-0d054bbcab63
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name isavuconazonium sulfate
Dosage form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route INTRAVENOUS
Labeler Astellas Pharma US, Inc.
Application NDA207501
Marketing category NDA
Marketing start 2015-03-06
Substance ISAVUCONAZONIUM SULFATE
Active strength 40 mg/mL
Pharmacologic classes Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 3A4 Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], P-Glycoprotein 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 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N207501-001 CRESEMBA ISAVUCONAZONIUM SULFATE 372MG POWDER / INTRAVENOUS RLD, RS 2015-03-06
Orange Book patents# Current patent rows page 1 of 1 · 2 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N207501-001 6812238 2025-10-31 Drug substance 2015-04-01 N207501-001 6812238*PED 2026-04-30 Pediatric extension
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 12 matching rows.
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 2 · 41 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 N207501-001 CRESEMBA 372MG POWDER / INTRAVENOUS RLD, RS 2015-03-06 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N207501-001 CRESEMBA 372MG POWDER / INTRAVENOUS RLD, RS 2015-03-06 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N207501-001 CRESEMBA 372MG POWDER / INTRAVENOUS RLD, RS 2015-03-06 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N207501-001 CRESEMBA 372MG POWDER / INTRAVENOUS RLD, RS 2015-03-06 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N207501-001 CRESEMBA 372MG POWDER / INTRAVENOUS RLD, RS 2015-03-06 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N207501-001 CRESEMBA 372MG POWDER / INTRAVENOUS RLD, RS 2015-03-06 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N207501-001 CRESEMBA 372MG POWDER / INTRAVENOUS RLD, RS 2015-03-06 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N207501-001 CRESEMBA 372MG POWDER / INTRAVENOUS RLD, RS 2015-03-06 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N207501-001 CRESEMBA 372MG POWDER / INTRAVENOUS RLD, RS 2015-03-06 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N207501-001 CRESEMBA 372MG POWDER / INTRAVENOUS RLD, RS 2015-03-06 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N207501-001 CRESEMBA 372MG POWDER / INTRAVENOUS RLD, RS 2015-03-06 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N207501-001 CRESEMBA 372MG POWDER / INTRAVENOUS RLD, RS 2015-03-06 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N207501-001 CRESEMBA 372MG POWDER / INTRAVENOUS RLD, RS 2015-03-06 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N207501-001 CRESEMBA 372MG POWDER / INTRAVENOUS RLD, RS 2015-03-06 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N207501-001 CRESEMBA 372MG POWDER / INTRAVENOUS RLD, RS 2015-03-06 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N207501-001 CRESEMBA 372MG POWDER / INTRAVENOUS RLD, RS 2015-03-06 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N207501-001 CRESEMBA 372MG POWDER / INTRAVENOUS RLD, RS 2015-03-06 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N207501-001 CRESEMBA 372MG POWDER / INTRAVENOUS RLD, RS 2015-03-06 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N207501-001 CRESEMBA 372MG POWDER / INTRAVENOUS RLD, RS 2015-03-06 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N207501-001 CRESEMBA 372MG POWDER / INTRAVENOUS RLD, RS 2015-03-06 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N207501-001 CRESEMBA 372MG POWDER / INTRAVENOUS RLD, RS 2015-03-06 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N207501-001 CRESEMBA 372MG POWDER / INTRAVENOUS RLD, RS 2015-03-06 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N207501-001 CRESEMBA 372MG POWDER / INTRAVENOUS RLD, RS 2015-03-06 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N207501-001 CRESEMBA 372MG POWDER / INTRAVENOUS RLD, RS 2015-03-06 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N207501-001 CRESEMBA 372MG POWDER / INTRAVENOUS RLD, RS 2015-03-06 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N207501-001 CRESEMBA 372MG POWDER / INTRAVENOUS RLD, RS 2015-03-06 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N207501-001 CRESEMBA 372MG POWDER / INTRAVENOUS RLD, RS 2015-03-06 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N207501-001 CRESEMBA 372MG POWDER / INTRAVENOUS RLD, RS 2015-03-06 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N207501-001 CRESEMBA 372MG POWDER / INTRAVENOUS RLD, RS 2015-03-06 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N207501-001 CRESEMBA 372MG POWDER / INTRAVENOUS RLD, RS 2015-03-06 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N207501-001 CRESEMBA 372MG POWDER / INTRAVENOUS RLD, RS 2015-03-06 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N207501-001 CRESEMBA 372MG POWDER / INTRAVENOUS RLD, RS 2015-03-06 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N207501-001 CRESEMBA 372MG POWDER / INTRAVENOUS RLD, RS 2015-03-06 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N207501-001 CRESEMBA 372MG POWDER / INTRAVENOUS RLD, RS 2015-03-06 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N207501-001 CRESEMBA 372MG POWDER / INTRAVENOUS RLD, RS 2015-03-06 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N207501-001 CRESEMBA 372MG POWDER / INTRAVENOUS RLD, RS 2015-03-06 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N207501-001 CRESEMBA 372MG POWDER / INTRAVENOUS RLD, RS 2015-03-06 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N207501-001 CRESEMBA 372MG POWDER / INTRAVENOUS RLD, RS 2015-03-06 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N207501-001 CRESEMBA 372MG POWDER / INTRAVENOUS RLD, RS 2015-03-06 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N207501-001 CRESEMBA 372MG POWDER / INTRAVENOUS RLD, RS 2015-03-06 cb3db0bc1861…
Observed Orange Book patent history# Patent history page 1 of 2 · 65 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 N207501-001 6812238 2025-10-31 Drug substance 2015-04-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N207501-001 6812238*PED 2026-04-30 Pediatric extension 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N207501-001 6812238 2025-10-31 Drug substance 2015-04-01 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N207501-001 6812238*PED 2026-04-30 Pediatric extension 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N207501-001 6812238 2025-10-31 Drug substance 2015-04-01 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N207501-001 6812238*PED 2026-04-30 Pediatric extension 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N207501-001 6812238 2025-10-31 Drug substance 2015-04-01 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N207501-001 6812238*PED 2026-04-30 Pediatric extension fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N207501-001 6812238 2025-10-31 Drug substance 2015-04-01 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N207501-001 6812238*PED 2026-04-30 Pediatric extension b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N207501-001 6812238 2025-10-31 Drug substance 2015-04-01 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N207501-001 6812238*PED 2026-04-30 Pediatric extension 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N207501-001 6812238 2025-10-31 Drug substance 2015-04-01 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N207501-001 6812238*PED 2026-04-30 Pediatric extension 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N207501-001 6812238 2025-10-31 Drug substance 2015-04-01 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N207501-001 6812238*PED 2026-05-01 Pediatric extension 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N207501-001 6812238 2025-10-31 Drug substance 2015-04-01 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N207501-001 6812238*PED 2026-04-30 Pediatric extension d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N207501-001 6812238 2025-10-31 Drug substance 2015-04-01 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N207501-001 6812238*PED 2026-05-01 Pediatric extension d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N207501-001 6812238 2025-10-31 Drug substance 2015-04-01 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N207501-001 6812238*PED 2026-05-01 Pediatric extension 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N207501-001 6812238 2025-10-31 Drug substance 2015-04-01 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N207501-001 6812238*PED 2026-05-01 Pediatric extension 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N207501-001 6812238 2025-10-31 Drug substance 2015-04-01 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N207501-001 6812238*PED 2026-05-01 Pediatric extension 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N207501-001 6812238 2025-10-31 Drug substance 2015-04-01 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N207501-001 6812238*PED 2026-05-01 Pediatric extension 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N207501-001 6812238 2025-10-31 Drug substance 2015-04-01 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N207501-001 6812238 2025-10-31 Drug substance 2015-04-01 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N207501-001 6812238 2025-10-31 Drug substance 2015-04-01 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N207501-001 6812238 2020-10-31 Drug substance 2015-04-01 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N207501-001 7459561 2020-10-31 Drug substance 2015-04-01 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N207501-001 6812238 2025-10-31 Drug substance 2015-04-01 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N207501-001 6812238 2025-10-31 Drug substance 2015-04-01 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N207501-001 6812238 2025-10-31 Drug substance 2015-04-01 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N207501-001 6812238 2025-10-31 Drug substance 2015-04-01 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N207501-001 7459561 2020-10-31 Drug substance 2015-04-01 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 N207501-001 6812238 2025-10-31 Drug substance 2015-04-01 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N207501-001 6812238 2020-10-31 Drug substance 2015-04-01 c0c555d07b60…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 10 · 381 observed states.
Additional Listing Data#
Finished product Yes
Brand name base CRESEMBA
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ISAVUCONAZONIUM SULFATE 40 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 31Q44514JV Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 6 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1608327 Internal RxNorm lookup 1608333 Internal RxNorm lookup 1608811 Internal RxNorm lookup 1608815 Internal RxNorm lookup 2623470 Internal RxNorm lookup 2623472 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 0469-0420-01 CRESEMBA 1 in 1 CARTON INJECTION, POWDER, LYOPHILIZED, 1 21 0469-0420-01 CRESEMBA 5 mL in 1 VIAL, SINGLE-DOSE INJECTION, POWDER, LYOPHILIZED, 5 21
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded ISAVUCONAZONIUM SULFATE ACTIVE INGREDIENT 31Q44514JV CRESEMBA (ISAVUCONAZONIUM SULFATE) CAPSULE CRESEMBA (ISAVUCONAZONIUM SULFATE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [ASTELLAS PHARMA US, INC.] 5 ISAVUCONAZOLE ACTIVE MOIETY 60UTO373KE CRESEMBA (ISAVUCONAZONIUM SULFATE) CAPSULE CRESEMBA (ISAVUCONAZONIUM SULFATE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [ASTELLAS PHARMA US, INC.] 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0469-0420 CRESEMBA (ISAVUCONAZONIUM SULFATE) CAPSULE CRESEMBA (ISAVUCONAZONIUM SULFATE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [ASTELLAS PHARMA US, INC.] 21 Current NDC, Legacy NDC, 2 package rows 20250503_8f7f73b8-586a-4df0-935f-fecd4696c16c.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.
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 0469-0420-01 00469042001 1 VIAL, SINGLE-DOSE in 1 CARTON (0469-0420-01) / 5 mL in 1 VIAL, SINGLE-DOSE 2015-03-06 0000-00-00 No No Current 0469-0420-99 00469042099 10 CARTON in 1 CARTON (0469-0420-99) > 1 VIAL, SINGLE-DOSE in 1 CARTON (0469-0420-01) > 5 mL in 1 VIAL, SINGLE-DOSE 10 carton 2015-03-06 0000-00-00 No No Current