CRESEMBA

Product NDC: 0469-0520
11-digit product format: 004690520
Labeler code: 0469
Product ID: 0469-0520_7e6e45d4-9266-4451-b6b6-0d054bbcab63
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: isavuconazonium sulfate
Dosage form: CAPSULE
Route: ORAL
Labeler: Astellas Pharma US, Inc.
Application: NDA207500
Marketing category: NDA
Marketing start: 2015-11-04
Substance: ISAVUCONAZONIUM SULFATE
Active strength: 100 mg/1
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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N207500-001	CRESEMBA	ISAVUCONAZONIUM SULFATE	186MG	CAPSULE / ORAL		RLD, RS	2015-03-06
N207500-002	CRESEMBA	ISAVUCONAZONIUM SULFATE	74.5MG	CAPSULE / ORAL		RLD	2022-11-22

Orange Book patents#

Current patent rows page 1 of 1 · 12 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Coverage / status	Submission date
N207500-001	6812238	2025-10-31	Drug substance	2015-04-01
N207500-001	6812238*PED	2026-04-30	Pediatric extension
N207500-001	10206879	2027-09-14	Drug product	2021-12-03
N207500-001	10603280	2027-09-14	Drug product	2021-12-03
N207500-001	10206879*PED	2028-03-14	Pediatric extension
N207500-001	10603280*PED	2028-03-14	Pediatric extension
N207500-002	6812238	2025-10-31	Drug substance	2023-06-29
N207500-002	6812238*PED	2026-04-30	Pediatric extension
N207500-002	10206879	2027-09-14	Drug product	2022-12-21
N207500-002	10603280	2027-09-14	Drug product	2022-12-21
N207500-002	10206879*PED	2028-03-14	Pediatric extension
N207500-002	10603280*PED	2028-03-14	Pediatric extension

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 21 matching rows.

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N207500-001	ODE-305	2022-03-06
N207500-001	ODE-90	2022-03-06
N207500-001	PED	2022-09-06
N207500-001	PED	2022-09-06
N207500-001	NPP	2026-12-08
N207500-001	PED	2027-06-08
N207500-001	GAIN	2027-09-06
N207500-001	GAIN	2027-09-06
N207500-001	ODE-454	2030-12-08
N207500-001	ODE-458	2030-12-08
N207500-001	PED	2031-06-08
N207500-001	PED	2031-06-08
N207500-002	ODE*	2022-03-06
N207500-002	PED	2022-09-06
N207500-002	NPP	2026-12-08
N207500-002	PED	2027-06-08
N207500-002	GAIN	2027-09-06
N207500-002	ODE-454	2030-12-08
N207500-002	ODE-458	2030-12-08
N207500-002	PED	2031-06-08
N207500-002	PED	2031-06-08

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 · 65 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N207500-001	CRESEMBA	186MG	CAPSULE / ORAL	RLD, RS	2015-03-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207500-002	CRESEMBA	74.5MG	CAPSULE / ORAL	RLD	2022-11-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207500-001	CRESEMBA	186MG	CAPSULE / ORAL	RLD, RS	2015-03-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207500-002	CRESEMBA	74.5MG	CAPSULE / ORAL	RLD	2022-11-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N207500-001	CRESEMBA	186MG	CAPSULE / ORAL	RLD, RS	2015-03-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N207500-002	CRESEMBA	74.5MG	CAPSULE / ORAL	RLD	2022-11-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N207500-001	CRESEMBA	186MG	CAPSULE / ORAL	RLD, RS	2015-03-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N207500-002	CRESEMBA	74.5MG	CAPSULE / ORAL	RLD	2022-11-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N207500-001	CRESEMBA	186MG	CAPSULE / ORAL	RLD, RS	2015-03-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N207500-002	CRESEMBA	74.5MG	CAPSULE / ORAL	RLD	2022-11-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N207500-001	CRESEMBA	186MG	CAPSULE / ORAL	RLD, RS	2015-03-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N207500-002	CRESEMBA	74.5MG	CAPSULE / ORAL	RLD	2022-11-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N207500-001	CRESEMBA	186MG	CAPSULE / ORAL	RLD, RS	2015-03-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N207500-002	CRESEMBA	74.5MG	CAPSULE / ORAL	RLD	2022-11-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N207500-001	CRESEMBA	186MG	CAPSULE / ORAL	RLD, RS	2015-03-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N207500-002	CRESEMBA	74.5MG	CAPSULE / ORAL	RLD	2022-11-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N207500-001	CRESEMBA	186MG	CAPSULE / ORAL	RLD, RS	2015-03-06	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N207500-002	CRESEMBA	74.5MG	CAPSULE / ORAL	RLD	2022-11-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N207500-001	CRESEMBA	186MG	CAPSULE / ORAL	RLD, RS	2015-03-06	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N207500-002	CRESEMBA	74.5MG	CAPSULE / ORAL	RLD	2022-11-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N207500-001	CRESEMBA	186MG	CAPSULE / ORAL	RLD, RS	2015-03-06	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N207500-002	CRESEMBA	74.5MG	CAPSULE / ORAL	RLD	2022-11-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N207500-001	CRESEMBA	186MG	CAPSULE / ORAL	RLD, RS	2015-03-06	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N207500-002	CRESEMBA	74.5MG	CAPSULE / ORAL	RLD	2022-11-22	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N207500-001	CRESEMBA	186MG	CAPSULE / ORAL	RLD, RS	2015-03-06	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N207500-002	CRESEMBA	74.5MG	CAPSULE / ORAL	RLD	2022-11-22	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N207500-001	CRESEMBA	186MG	CAPSULE / ORAL	RLD, RS	2015-03-06	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N207500-002	CRESEMBA	74.5MG	CAPSULE / ORAL	RLD	2022-11-22	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N207500-001	CRESEMBA	186MG	CAPSULE / ORAL	RLD, RS	2015-03-06	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N207500-001	CRESEMBA	186MG	CAPSULE / ORAL	RLD, RS	2015-03-06	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N207500-001	CRESEMBA	186MG	CAPSULE / ORAL	RLD, RS	2015-03-06	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N207500-001	CRESEMBA	186MG	CAPSULE / ORAL	RLD, RS	2015-03-06	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N207500-001	CRESEMBA	186MG	CAPSULE / ORAL	RLD, RS	2015-03-06	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N207500-001	CRESEMBA	186MG	CAPSULE / ORAL	RLD, RS	2015-03-06	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N207500-001	CRESEMBA	186MG	CAPSULE / ORAL	RLD, RS	2015-03-06	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N207500-001	CRESEMBA	186MG	CAPSULE / ORAL	RLD, RS	2015-03-06	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N207500-001	CRESEMBA	186MG	CAPSULE / ORAL	RLD, RS	2015-03-06	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N207500-001	CRESEMBA	186MG	CAPSULE / ORAL	RLD, RS	2015-03-06	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N207500-001	CRESEMBA	186MG	CAPSULE / ORAL	RLD, RS	2015-03-06	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N207500-001	CRESEMBA	186MG	CAPSULE / ORAL	RLD, RS	2015-03-06	`b00525d2431f…`

Observed Orange Book patent history#

Patent history page 1 of 8 · 293 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	Submission date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N207500-001	6812238	2025-10-31	Drug substance	2015-04-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207500-001	6812238*PED	2026-04-30	Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207500-001	10206879	2027-09-14	Drug product	2021-12-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207500-001	10603280	2027-09-14	Drug product	2021-12-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207500-001	10206879*PED	2028-03-14	Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207500-001	10603280*PED	2028-03-14	Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207500-002	6812238	2025-10-31	Drug substance	2023-06-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207500-002	6812238*PED	2026-04-30	Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207500-002	10206879	2027-09-14	Drug product	2022-12-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207500-002	10603280	2027-09-14	Drug product	2022-12-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207500-002	10206879*PED	2028-03-14	Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207500-002	10603280*PED	2028-03-14	Pediatric extension		`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207500-001	6812238	2025-10-31	Drug substance	2015-04-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207500-001	6812238*PED	2026-04-30	Pediatric extension		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207500-001	10206879	2027-09-14	Drug product	2021-12-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207500-001	10603280	2027-09-14	Drug product	2021-12-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207500-001	10206879*PED	2028-03-14	Pediatric extension		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207500-001	10603280*PED	2028-03-14	Pediatric extension		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207500-002	6812238	2025-10-31	Drug substance	2023-06-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207500-002	6812238*PED	2026-04-30	Pediatric extension		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207500-002	10206879	2027-09-14	Drug product	2022-12-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207500-002	10603280	2027-09-14	Drug product	2022-12-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207500-002	10206879*PED	2028-03-14	Pediatric extension		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207500-002	10603280*PED	2028-03-14	Pediatric extension		`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N207500-001	6812238	2025-10-31	Drug substance	2015-04-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N207500-001	6812238*PED	2026-04-30	Pediatric extension		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N207500-001	10206879	2027-09-14	Drug product	2021-12-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N207500-001	10603280	2027-09-14	Drug product	2021-12-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N207500-001	10206879*PED	2028-03-14	Pediatric extension		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N207500-001	10603280*PED	2028-03-14	Pediatric extension		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N207500-002	6812238	2025-10-31	Drug substance	2023-06-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N207500-002	6812238*PED	2026-04-30	Pediatric extension		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N207500-002	10206879	2027-09-14	Drug product	2022-12-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N207500-002	10603280	2027-09-14	Drug product	2022-12-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N207500-002	10206879*PED	2028-03-14	Pediatric extension		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N207500-002	10603280*PED	2028-03-14	Pediatric extension		`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N207500-001	6812238	2025-10-31	Drug substance	2015-04-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N207500-001	6812238*PED	2026-04-30	Pediatric extension		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N207500-001	10206879	2027-09-14	Drug product	2021-12-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N207500-001	10603280	2027-09-14	Drug product	2021-12-03	`fd3edfee7708…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 16 · 602 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N207500-001	ODE-305	2022-03-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207500-001	ODE-90	2022-03-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207500-001	PED	2022-09-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207500-001	PED	2022-09-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207500-001	NPP	2026-12-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207500-001	PED	2027-06-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207500-001	GAIN	2027-09-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207500-001	GAIN	2027-09-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207500-001	ODE-454	2030-12-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207500-001	ODE-458	2030-12-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207500-001	PED	2031-06-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207500-001	PED	2031-06-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207500-002	ODE*	2022-03-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207500-002	PED	2022-09-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207500-002	NPP	2026-12-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207500-002	PED	2027-06-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207500-002	GAIN	2027-09-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207500-002	ODE-454	2030-12-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207500-002	ODE-458	2030-12-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207500-002	PED	2031-06-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207500-002	PED	2031-06-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207500-001	NCE	2020-03-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207500-001	PED	2020-09-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207500-001	ODE-305	2022-03-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207500-001	ODE-90	2022-03-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207500-001	PED	2022-09-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207500-001	PED	2022-09-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207500-001	GAIN	2025-09-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207500-001	NPP	2026-12-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207500-001	PED	2027-06-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207500-001	GAIN	2027-09-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207500-001	GAIN	2027-09-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207500-001	ODE-454	2030-12-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207500-001	ODE-458	2030-12-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207500-001	PED	2031-06-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207500-001	PED	2031-06-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207500-002	NCE	2020-03-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207500-002	PED	2020-09-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207500-002	ODE*	2022-03-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207500-002	PED	2022-09-06	`31067a03dcf5…`

Additional Listing Data#

Finished product: Yes
Brand name base: CRESEMBA
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ISAVUCONAZONIUM SULFATE	100 mg/1

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.

Identifier, FDA.report destination table
Identifier	FDA.report destination
8f7f73b8-586a-4df0-935f-fecd4696c16c	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
21e6fa12-f0b8-4d5e-b258-d1f0e9e87660	Product name	1	20150423

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0469-0520-02	CRESEMBA	7 in 1 BLISTER PACK	CAPSULE	7		21
0469-0520-02	CRESEMBA	2 in 1 CARTON	CAPSULE	2		21

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0469-0520-02	EA - Each	0469-0520	9219b180-4d7a-4052-a5b1-17a96116d410	1	2022-12-07
0469-0520-14	EA - Each	0469-0520	77db1c80-ec8f-4a0d-8c8b-2b7216d7f238	1	2015-12-02

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
0469-0520	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.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
CRESEMBA	ISAVUCONAZONIUM SULFATE	Astellas Pharma US, Inc.	8f7f73b8-586a-4df0-935f-fecd4696c16c	2025-04-25	Warnings, Adverse reactions	Exact identifier application applno (NDA): 207500 application number: NDA207500 ndc (product): 0469-0520

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
31Q44514JV	ISAVUCONAZONIUM SULFATE	946075-13-4	ISAVUCONAZONIUM SULFATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1608333	Cresemba 186 MG Oral Capsule	PSN	8f7f73b8-586a-4df0-935f-fecd4696c16c	21
1608815	Cresemba 372 MG Injection	PSN	8f7f73b8-586a-4df0-935f-fecd4696c16c	21
2623472	Cresemba 74.5 MG Oral Capsule	PSN	8f7f73b8-586a-4df0-935f-fecd4696c16c	21
1608327	isavuconazonium sulfate 186 MG Oral Capsule	PSN	8f7f73b8-586a-4df0-935f-fecd4696c16c	21
1608811	isavuconazonium sulfate 372 Injection	PSN	8f7f73b8-586a-4df0-935f-fecd4696c16c	21
2623470	isavuconazonium sulfate 74.5 MG Oral Capsule	PSN	8f7f73b8-586a-4df0-935f-fecd4696c16c	21
1608333	isavuconazonium sulfate 186 MG Oral Capsule [Cresemba]	SBD	8f7f73b8-586a-4df0-935f-fecd4696c16c	21
1608815	isavuconazonium sulfate 372 MG Injection [Cresemba]	SBD	8f7f73b8-586a-4df0-935f-fecd4696c16c	21
2623472	isavuconazonium sulfate 74.5 MG Oral Capsule [Cresemba]	SBD	8f7f73b8-586a-4df0-935f-fecd4696c16c	21
1608327	isavuconazonium sulfate 186 MG Oral Capsule	SCD	8f7f73b8-586a-4df0-935f-fecd4696c16c	21
1608811	isavuconazonium sulfate 372 MG Injection	SCD	8f7f73b8-586a-4df0-935f-fecd4696c16c	21
2623470	isavuconazonium sulfate 74.5 MG Oral Capsule	SCD	8f7f73b8-586a-4df0-935f-fecd4696c16c	21
1608333	Cresemba 186 MG (isavuconazole 100 MG) Oral Capsule	SY	8f7f73b8-586a-4df0-935f-fecd4696c16c	21
1608333	Cresemba 186 MG Oral Capsule	SY	8f7f73b8-586a-4df0-935f-fecd4696c16c	21
1608815	Cresemba 372 MG Injection	SY	8f7f73b8-586a-4df0-935f-fecd4696c16c	21
2623472	Cresemba 74.5 MG (isavuconazole 40 MG) Oral Capsule	SY	8f7f73b8-586a-4df0-935f-fecd4696c16c	21
2623472	Cresemba 74.5 MG Oral Capsule	SY	8f7f73b8-586a-4df0-935f-fecd4696c16c	21
1608327	isavuconazonium sulfate 186 MG (isavuconazole 100 MG) Oral Capsule	SY	8f7f73b8-586a-4df0-935f-fecd4696c16c	21
2623470	isavuconazonium sulfate 74.5 MG (isavuconazole 40 MG) Oral Capsule	SY	8f7f73b8-586a-4df0-935f-fecd4696c16c	21

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0469-0520-02	00469052002	2 BLISTER PACK in 1 CARTON (0469-0520-02) / 7 CAPSULE in 1 BLISTER PACK	2 blister pack	2015-11-04		No	No	Current
0469-0520-14	00469052014	4 CARTON in 1 CARTON (0469-0520-14) > 14 BLISTER PACK in 1 CARTON (0469-0520-02) > 1 CAPSULE in 1 BLISTER PACK	4 carton	2015-11-04	0000-00-00	No	No	Current