CANCIDAS

Product NDC: 0006-3823
11-digit product format: 000063823
Labeler code: 0006
Product ID: 0006-3823_42355646-adc3-4d93-b20f-07bd8a2468ac
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: CASPOFUNGIN ACETATE
Dosage form: INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route: INTRAVENOUS
Labeler: Merck Sharp & Dohme LLC
Application: NDA021227
Marketing category: NDA
Marketing start: 2001-01-26
Substance: CASPOFUNGIN ACETATE
Active strength: 7 mg/mL
Pharmacologic classes: Echinocandin Antifungal [EPC], Lipopeptides [CS]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
N021227-001	CANCIDAS	CASPOFUNGIN ACETATE	50MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	POWDER / INTRAVENOUS		RLD	2001-01-26
N021227-002	CANCIDAS	CASPOFUNGIN ACETATE	70MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	POWDER / INTRAVENOUS		RLD	2001-01-26

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 · 88 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
2026-10-15 13:18:30	2026-09	N021227-001	CANCIDAS	50MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	POWDER / INTRAVENOUS		RLD	2001-01-26	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N021227-002	CANCIDAS	70MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	POWDER / INTRAVENOUS		RLD	2001-01-26	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N021227-001	CANCIDAS	50MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	POWDER / INTRAVENOUS		RLD	2001-01-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021227-002	CANCIDAS	70MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	POWDER / INTRAVENOUS		RLD	2001-01-26	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N021227-001	CANCIDAS	50MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	POWDER / INTRAVENOUS		RLD	2001-01-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021227-002	CANCIDAS	70MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	POWDER / INTRAVENOUS		RLD	2001-01-26	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021227-001	CANCIDAS	50MG/VIAL	POWDER / INTRAVENOUS		RLD	2001-01-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021227-002	CANCIDAS	70MG/VIAL	POWDER / INTRAVENOUS		RLD	2001-01-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021227-001	CANCIDAS	50MG/VIAL	POWDER / INTRAVENOUS		RLD	2001-01-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021227-002	CANCIDAS	70MG/VIAL	POWDER / INTRAVENOUS		RLD	2001-01-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021227-001	CANCIDAS	50MG/VIAL	POWDER / INTRAVENOUS		RLD	2001-01-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021227-002	CANCIDAS	70MG/VIAL	POWDER / INTRAVENOUS		RLD	2001-01-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021227-001	CANCIDAS	50MG/VIAL	POWDER / INTRAVENOUS		RLD	2001-01-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021227-002	CANCIDAS	70MG/VIAL	POWDER / INTRAVENOUS		RLD	2001-01-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021227-001	CANCIDAS	50MG/VIAL	POWDER / INTRAVENOUS		RLD	2001-01-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021227-002	CANCIDAS	70MG/VIAL	POWDER / INTRAVENOUS		RLD	2001-01-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021227-001	CANCIDAS	50MG/VIAL	POWDER / INTRAVENOUS		RLD	2001-01-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021227-002	CANCIDAS	70MG/VIAL	POWDER / INTRAVENOUS		RLD	2001-01-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021227-001	CANCIDAS	50MG/VIAL	POWDER / INTRAVENOUS	AP	RLD, RS	2001-01-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021227-002	CANCIDAS	70MG/VIAL	POWDER / INTRAVENOUS	AP	RLD, RS	2001-01-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021227-001	CANCIDAS	50MG/VIAL	POWDER / INTRAVENOUS	AP	RLD, RS	2001-01-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021227-002	CANCIDAS	70MG/VIAL	POWDER / INTRAVENOUS	AP	RLD, RS	2001-01-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021227-001	CANCIDAS	50MG/VIAL	POWDER / INTRAVENOUS	AP	RLD, RS	2001-01-26	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021227-002	CANCIDAS	70MG/VIAL	POWDER / INTRAVENOUS	AP	RLD, RS	2001-01-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021227-001	CANCIDAS	50MG/VIAL	POWDER / INTRAVENOUS	AP	RLD, RS	2001-01-26	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021227-002	CANCIDAS	70MG/VIAL	POWDER / INTRAVENOUS	AP	RLD, RS	2001-01-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021227-001	CANCIDAS	50MG/VIAL	POWDER / INTRAVENOUS	AP	RLD, RS	2001-01-26	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021227-002	CANCIDAS	70MG/VIAL	POWDER / INTRAVENOUS	AP	RLD, RS	2001-01-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021227-001	CANCIDAS	50MG/VIAL	POWDER / INTRAVENOUS	AP	RLD, RS	2001-01-26	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021227-002	CANCIDAS	70MG/VIAL	POWDER / INTRAVENOUS	AP	RLD, RS	2001-01-26	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021227-001	CANCIDAS	50MG/VIAL	POWDER / INTRAVENOUS	AP	RLD, RS	2001-01-26	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021227-002	CANCIDAS	70MG/VIAL	POWDER / INTRAVENOUS	AP	RLD, RS	2001-01-26	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021227-001	CANCIDAS	50MG/VIAL	POWDER / INTRAVENOUS	AP	RLD, RS	2001-01-26	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N021227-002	CANCIDAS	70MG/VIAL	POWDER / INTRAVENOUS	AP	RLD, RS	2001-01-26	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021227-001	CANCIDAS	50MG/VIAL	POWDER / INTRAVENOUS	AP	RLD, RS	2001-01-26	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021227-002	CANCIDAS	70MG/VIAL	POWDER / INTRAVENOUS	AP	RLD, RS	2001-01-26	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021227-001	CANCIDAS	50MG/VIAL	POWDER / INTRAVENOUS	AP	RLD, RS	2001-01-26	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021227-002	CANCIDAS	70MG/VIAL	POWDER / INTRAVENOUS	AP	RLD, RS	2001-01-26	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021227-001	CANCIDAS	50MG/VIAL	POWDER / INTRAVENOUS	AP	RLD, RS	2001-01-26	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021227-002	CANCIDAS	70MG/VIAL	POWDER / INTRAVENOUS	AP	RLD, RS	2001-01-26	`4b0b4de00fa7…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 68 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021227-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021227-002	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021227-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021227-002	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021227-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021227-002	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021227-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021227-002	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021227-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021227-002	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021227-001	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021227-002	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021227-001	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021227-002	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021227-001	AP	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N021227-002	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021227-001	AP	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021227-002	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021227-001	AP	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021227-002	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021227-001	AP	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021227-002	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021227-001	AP	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021227-002	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021227-001	AP	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N021227-002	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021227-001	AP	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021227-002	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021227-001	AP	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021227-002	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021227-001	AP	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N021227-002	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021227-001	AP	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021227-002	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021227-001	AP	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021227-002	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021227-001	AP	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021227-002	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021227-001	AP	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021227-002	AP	1	`b00525d2431f…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product: Yes
Brand name base: CANCIDAS
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
CASPOFUNGIN ACETATE	7 mg/mL

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
3e090fbd-2b26-41f0-87f0-76e9459efe59	Product name	3	20220317
a62a50ac-1535-4461-9768-8ae703e2e9fb	Product name	1	20210525
48747306-602a-42cc-957b-5b0c69158eee	Product name	1	20180604
3e090fbd-2b26-41f0-87f0-76e9459efe59	Product name	1	20171121
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877	Product name	1	20140508
bc07ef78-e82d-0c19-31f4-31f263780582	Product name	1	20140508
db5ebcdb-b6ae-21cd-4dc5-76cd84b5578b	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0006-3823-10	CANCIDAS	1 in 1 CARTON	INJECTION, POWDER, LYOPHILIZED,	1		41
0006-3823-10	CANCIDAS	10.8 mL in 1 VIAL, SINGLE-USE	INJECTION, POWDER, LYOPHILIZED,	10.8		41

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0006-3823-10	EA - Each	0006-3823	290e6d53-e3d3-4fb6-a85c-4ddd1be7caf6	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
CASPOFUNGIN ACETATE	ACTIVE INGREDIENT	VUW370O5QE	CANCIDAS (CASPOFUNGIN ACETATE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MERCK SHARP & DOHME CORP.]	20
CASPOFUNGIN	ACTIVE MOIETY	F0XDI6ZL63	CANCIDAS (CASPOFUNGIN ACETATE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MERCK SHARP & DOHME CORP.]	20
ACETIC ACID	INACTIVE INGREDIENT	Q40Q9N063P	CANCIDAS (CASPOFUNGIN ACETATE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MERCK SHARP & DOHME CORP.]	20
MANNITOL	INACTIVE INGREDIENT	3OWL53L36A	CANCIDAS (CASPOFUNGIN ACETATE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MERCK SHARP & DOHME CORP.]	20
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	CANCIDAS (CASPOFUNGIN ACETATE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MERCK SHARP & DOHME CORP.]	20
SUCROSE	INACTIVE INGREDIENT	C151H8M554	CANCIDAS (CASPOFUNGIN ACETATE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MERCK SHARP & DOHME CORP.]	20

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0006-3823	CANCIDAS (CASPOFUNGIN ACETATE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MERCK SHARP & DOHME LLC]	40	Current NDC, Legacy NDC, 2 package rows	20241018_3bad23a6-09a6-4194-9182-093ed61bc71c.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
VUW370O5QE	CASPOFUNGIN ACETATE	179463-17-3	CASPOFUNGIN ACETATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
828757	Cancidas 50 MG Injection	PSN	3bad23a6-09a6-4194-9182-093ed61bc71c	41
828541	Cancidas 70 MG Injection	PSN	3bad23a6-09a6-4194-9182-093ed61bc71c	41
828755	caspofungin acetate 50 MG Injection	PSN	3bad23a6-09a6-4194-9182-093ed61bc71c	41
828539	caspofungin acetate 70 MG Injection	PSN	3bad23a6-09a6-4194-9182-093ed61bc71c	41
828757	caspofungin acetate 50 MG Injection [Cancidas]	SBD	3bad23a6-09a6-4194-9182-093ed61bc71c	41
828541	caspofungin acetate 70 MG Injection [Cancidas]	SBD	3bad23a6-09a6-4194-9182-093ed61bc71c	41
828755	caspofungin acetate 50 MG Injection	SCD	3bad23a6-09a6-4194-9182-093ed61bc71c	41
828539	caspofungin acetate 70 MG Injection	SCD	3bad23a6-09a6-4194-9182-093ed61bc71c	41
828757	Cancidas 50 MG (equivalent to caspofungin 54.6 MG) Injection	SY	3bad23a6-09a6-4194-9182-093ed61bc71c	41
828757	Cancidas 50 MG Injection	SY	3bad23a6-09a6-4194-9182-093ed61bc71c	41
828541	Cancidas 70 MG (equivalent to caspofungin 75.6 MG) Injection	SY	3bad23a6-09a6-4194-9182-093ed61bc71c	41
828541	Cancidas 70 MG Injection	SY	3bad23a6-09a6-4194-9182-093ed61bc71c	41
828755	caspofungin acetate 50 MG (equivalent to caspofungin 54.6 MG) Injection	SY	3bad23a6-09a6-4194-9182-093ed61bc71c	41
828539	caspofungin acetate 70 MG (equivalent to caspofungin 75.6 MG) Injection	SY	3bad23a6-09a6-4194-9182-093ed61bc71c	41

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
0006-3823-10	00006382310	1 VIAL, SINGLE-USE in 1 CARTON (0006-3823-10) / 10.8 mL in 1 VIAL, SINGLE-USE	2001-01-26	0000-00-00	No	No	Current