Caspofungin Acetate

Product NDC: 68083-159
Requested package NDC: 68083-159-01
11-digit product format: 680830159
Labeler code: 68083
Product ID: 68083-159_0ebc13ad-ba33-408f-8af3-cf995efc4df2
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Caspofungin Acetate
Dosage form: INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route: INTRAVENOUS
Labeler: Gland Pharma Limited
Application: ANDA207092
Marketing category: ANDA
Marketing start: 2017-10-29
Substance: CASPOFUNGIN ACETATE
Active strength: 7 mg/mL
Pharmacologic classes: Echinocandin Antifungal [EPC], Lipopeptides [CS]
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 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
A207092-001	CASPOFUNGIN ACETATE	CASPOFUNGIN ACETATE	50MG/VIAL	POWDER / INTRAVENOUS	AP	RS	2017-09-29
A207092-002	CASPOFUNGIN ACETATE	CASPOFUNGIN ACETATE	70MG/VIAL	POWDER / INTRAVENOUS	AP	RS	2017-09-29

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A207092-001	AP
A207092-002	AP

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	A207092-001	CASPOFUNGIN ACETATE	50MG/VIAL	POWDER / INTRAVENOUS	AP	RS	2017-09-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A207092-002	CASPOFUNGIN ACETATE	70MG/VIAL	POWDER / INTRAVENOUS	AP	RS	2017-09-29	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A207092-001	CASPOFUNGIN ACETATE	50MG/VIAL	POWDER / INTRAVENOUS	AP	RS	2017-09-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207092-002	CASPOFUNGIN ACETATE	70MG/VIAL	POWDER / INTRAVENOUS	AP	RS	2017-09-29	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A207092-001	CASPOFUNGIN ACETATE	50MG/VIAL	POWDER / INTRAVENOUS	AP		2017-09-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207092-002	CASPOFUNGIN ACETATE	70MG/VIAL	POWDER / INTRAVENOUS	AP		2017-09-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207092-001	CASPOFUNGIN ACETATE	50MG/VIAL	POWDER / INTRAVENOUS	AP		2017-09-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207092-002	CASPOFUNGIN ACETATE	70MG/VIAL	POWDER / INTRAVENOUS	AP		2017-09-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207092-001	CASPOFUNGIN ACETATE	50MG/VIAL	POWDER / INTRAVENOUS	AP		2017-09-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207092-002	CASPOFUNGIN ACETATE	70MG/VIAL	POWDER / INTRAVENOUS	AP		2017-09-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207092-001	CASPOFUNGIN ACETATE	50MG/VIAL	POWDER / INTRAVENOUS	AP		2017-09-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207092-002	CASPOFUNGIN ACETATE	70MG/VIAL	POWDER / INTRAVENOUS	AP		2017-09-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207092-001	CASPOFUNGIN ACETATE	50MG/VIAL	POWDER / INTRAVENOUS	AP		2017-09-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207092-002	CASPOFUNGIN ACETATE	70MG/VIAL	POWDER / INTRAVENOUS	AP		2017-09-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207092-001	CASPOFUNGIN ACETATE	50MG/VIAL	POWDER / INTRAVENOUS	AP		2017-09-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207092-002	CASPOFUNGIN ACETATE	70MG/VIAL	POWDER / INTRAVENOUS	AP		2017-09-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207092-001	CASPOFUNGIN ACETATE	50MG/VIAL	POWDER / INTRAVENOUS	AP		2017-09-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207092-002	CASPOFUNGIN ACETATE	70MG/VIAL	POWDER / INTRAVENOUS	AP		2017-09-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207092-001	CASPOFUNGIN ACETATE	50MG/VIAL	POWDER / INTRAVENOUS	AP		2017-09-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207092-002	CASPOFUNGIN ACETATE	70MG/VIAL	POWDER / INTRAVENOUS	AP		2017-09-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207092-001	CASPOFUNGIN ACETATE	50MG/VIAL	POWDER / INTRAVENOUS	AP		2017-09-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207092-002	CASPOFUNGIN ACETATE	70MG/VIAL	POWDER / INTRAVENOUS	AP		2017-09-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207092-001	CASPOFUNGIN ACETATE	50MG/VIAL	POWDER / INTRAVENOUS	AP		2017-09-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207092-002	CASPOFUNGIN ACETATE	70MG/VIAL	POWDER / INTRAVENOUS	AP		2017-09-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207092-001	CASPOFUNGIN ACETATE	50MG/VIAL	POWDER / INTRAVENOUS	AP		2017-09-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207092-002	CASPOFUNGIN ACETATE	70MG/VIAL	POWDER / INTRAVENOUS	AP		2017-09-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207092-001	CASPOFUNGIN ACETATE	50MG/VIAL	POWDER / INTRAVENOUS	AP		2017-09-29	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207092-002	CASPOFUNGIN ACETATE	70MG/VIAL	POWDER / INTRAVENOUS	AP		2017-09-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207092-001	CASPOFUNGIN ACETATE	50MG/VIAL	POWDER / INTRAVENOUS	AP		2017-09-29	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207092-002	CASPOFUNGIN ACETATE	70MG/VIAL	POWDER / INTRAVENOUS	AP		2017-09-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207092-001	CASPOFUNGIN ACETATE	50MG/VIAL	POWDER / INTRAVENOUS	AP		2017-09-29	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A207092-002	CASPOFUNGIN ACETATE	70MG/VIAL	POWDER / INTRAVENOUS	AP		2017-09-29	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207092-001	CASPOFUNGIN ACETATE	50MG/VIAL	POWDER / INTRAVENOUS	AP		2017-09-29	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207092-002	CASPOFUNGIN ACETATE	70MG/VIAL	POWDER / INTRAVENOUS	AP		2017-09-29	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207092-001	CASPOFUNGIN ACETATE	50MG/VIAL	POWDER / INTRAVENOUS	AP		2017-09-29	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A207092-002	CASPOFUNGIN ACETATE	70MG/VIAL	POWDER / INTRAVENOUS	AP		2017-09-29	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207092-001	CASPOFUNGIN ACETATE	50MG/VIAL	POWDER / INTRAVENOUS	AP		2017-09-29	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A207092-002	CASPOFUNGIN ACETATE	70MG/VIAL	POWDER / INTRAVENOUS	AP		2017-09-29	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A207092-001	CASPOFUNGIN ACETATE	50MG/VIAL	POWDER / INTRAVENOUS	AP		2017-09-29	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A207092-002	CASPOFUNGIN ACETATE	70MG/VIAL	POWDER / INTRAVENOUS	AP		2017-09-29	`74a2ff9319b5…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A207092-001	AP	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A207092-002	AP	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A207092-001	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207092-002	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A207092-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207092-002	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207092-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207092-002	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207092-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207092-002	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207092-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207092-002	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207092-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207092-002	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207092-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207092-002	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207092-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207092-002	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207092-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207092-002	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207092-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207092-002	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207092-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207092-002	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207092-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207092-002	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207092-001	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207092-002	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207092-001	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207092-002	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207092-001	AP	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A207092-002	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207092-001	AP	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207092-002	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207092-001	AP	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A207092-002	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207092-001	AP	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A207092-002	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A207092-001	AP	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A207092-002	AP	1	`74a2ff9319b5…`

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: Caspofungin Acetate
Listing expiration: 2026-12-31

Active Ingredients#

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

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
VUW370O5QE	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
828539	Internal RxNorm lookup
828755	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
29da357e-e7fc-46af-bf20-806a1e4b5391	Available on FDA.report

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
68083-159-01	Caspofungin Acetate	1 in 1 CARTON	INJECTION, POWDER, LYOPHILIZED,	1		13
68083-159-01	Caspofungin Acetate	10 mL in 1 VIAL	INJECTION, POWDER, LYOPHILIZED,	10		13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68083-159	CASPOFUNGIN ACETATE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [GLAND PHARMA LIMITED]	13	Current NDC, Legacy NDC, 2 package rows	20220122_29da357e-e7fc-46af-bf20-806a1e4b5391.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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Caspofungin Acetate	CASPOFUNGIN ACETATE	Sagent Pharmaceuticals	08fb61ee-a05a-4ce1-934c-8cd26c5733db	2026-07-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207092 application number: ANDA207092
Caspofungin Acetate	CASPOFUNGIN ACETATE	Fosun Pharma USA Inc.	cbd33696-e059-4e27-a782-95e23e8159b8	2022-03-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207092 application number: ANDA207092
Caspofungin Acetate	CASPOFUNGIN ACETATE	Gland Pharma Limited	29da357e-e7fc-46af-bf20-806a1e4b5391	2022-01-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207092 application number: ANDA207092 ndc (package): 68083-159-01 ndc (product): 68083-159 ndc11 (package): 68083015901

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
828755	caspofungin acetate 50 MG Injection	PSN	29da357e-e7fc-46af-bf20-806a1e4b5391	13
828539	caspofungin acetate 70 MG Injection	PSN	29da357e-e7fc-46af-bf20-806a1e4b5391	13
828755	caspofungin acetate 50 MG Injection	SCD	29da357e-e7fc-46af-bf20-806a1e4b5391	13
828539	caspofungin acetate 70 MG Injection	SCD	29da357e-e7fc-46af-bf20-806a1e4b5391	13
828755	caspofungin acetate 50 MG (equivalent to caspofungin 54.6 MG) Injection	SY	29da357e-e7fc-46af-bf20-806a1e4b5391	13
828539	caspofungin acetate 70 MG (equivalent to caspofungin 75.6 MG) Injection	SY	29da357e-e7fc-46af-bf20-806a1e4b5391	13

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68083-159-01	68083015901	1 VIAL in 1 CARTON (68083-159-01) / 10 mL in 1 VIAL	1 vial	2017-10-29	0000-00-00	No	No	Current