Caspofungin Acetate

Product NDC
72266-107
11-digit product format
722660107
Labeler code
72266
Product ID
72266-107_33511a66-d80a-d052-e063-6294a90a9459
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Caspofungin Acetate
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Fosun Pharma USA Inc.
Application
ANDA207092
Marketing category
ANDA
Marketing start
2019-04-02
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 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A207092-001CASPOFUNGIN ACETATECASPOFUNGIN ACETATE50MG/VIALPOWDER / INTRAVENOUSAPRS2017-09-29
A207092-002CASPOFUNGIN ACETATECASPOFUNGIN ACETATE70MG/VIALPOWDER / INTRAVENOUSAPRS2017-09-29

Therapeutic equivalence codes#

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

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

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 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A207092-001CASPOFUNGIN ACETATE50MG/VIALPOWDER / INTRAVENOUSAP2017-09-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207092-002CASPOFUNGIN ACETATE70MG/VIALPOWDER / INTRAVENOUSAP2017-09-29011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207092-001CASPOFUNGIN ACETATE50MG/VIALPOWDER / INTRAVENOUSAP2017-09-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207092-002CASPOFUNGIN ACETATE70MG/VIALPOWDER / INTRAVENOUSAP2017-09-2931067a03dcf5…
2025-08-23 18:47 UTC2025-08A207092-001CASPOFUNGIN ACETATE50MG/VIALPOWDER / INTRAVENOUSAP2017-09-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207092-002CASPOFUNGIN ACETATE70MG/VIALPOWDER / INTRAVENOUSAP2017-09-296a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207092-001CASPOFUNGIN ACETATE50MG/VIALPOWDER / INTRAVENOUSAP2017-09-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207092-002CASPOFUNGIN ACETATE70MG/VIALPOWDER / INTRAVENOUSAP2017-09-29fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207092-001CASPOFUNGIN ACETATE50MG/VIALPOWDER / INTRAVENOUSAP2017-09-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207092-002CASPOFUNGIN ACETATE70MG/VIALPOWDER / INTRAVENOUSAP2017-09-29b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207092-001CASPOFUNGIN ACETATE50MG/VIALPOWDER / INTRAVENOUSAP2017-09-2903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207092-002CASPOFUNGIN ACETATE70MG/VIALPOWDER / INTRAVENOUSAP2017-09-2903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207092-001CASPOFUNGIN ACETATE50MG/VIALPOWDER / INTRAVENOUSAP2017-09-292680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207092-002CASPOFUNGIN ACETATE70MG/VIALPOWDER / INTRAVENOUSAP2017-09-292680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207092-001CASPOFUNGIN ACETATE50MG/VIALPOWDER / INTRAVENOUSAP2017-09-295bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207092-002CASPOFUNGIN ACETATE70MG/VIALPOWDER / INTRAVENOUSAP2017-09-295bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207092-001CASPOFUNGIN ACETATE50MG/VIALPOWDER / INTRAVENOUSAP2017-09-29d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207092-002CASPOFUNGIN ACETATE70MG/VIALPOWDER / INTRAVENOUSAP2017-09-29d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A207092-001CASPOFUNGIN ACETATE50MG/VIALPOWDER / INTRAVENOUSAP2017-09-29d06236e962d9…
2024-10-29 15:01 UTC2024-10A207092-002CASPOFUNGIN ACETATE70MG/VIALPOWDER / INTRAVENOUSAP2017-09-29d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207092-001CASPOFUNGIN ACETATE50MG/VIALPOWDER / INTRAVENOUSAP2017-09-2979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207092-002CASPOFUNGIN ACETATE70MG/VIALPOWDER / INTRAVENOUSAP2017-09-2979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207092-001CASPOFUNGIN ACETATE50MG/VIALPOWDER / INTRAVENOUSAP2017-09-29301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207092-002CASPOFUNGIN ACETATE70MG/VIALPOWDER / INTRAVENOUSAP2017-09-29301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A207092-001CASPOFUNGIN ACETATE50MG/VIALPOWDER / INTRAVENOUSAP2017-09-291e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A207092-002CASPOFUNGIN ACETATE70MG/VIALPOWDER / INTRAVENOUSAP2017-09-291e350fbaab3a…
2024-05-31 18:47 UTC2024-05A207092-001CASPOFUNGIN ACETATE50MG/VIALPOWDER / INTRAVENOUSAP2017-09-298072bd15b7f6…
2024-05-31 18:47 UTC2024-05A207092-002CASPOFUNGIN ACETATE70MG/VIALPOWDER / INTRAVENOUSAP2017-09-298072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A207092-001CASPOFUNGIN ACETATE50MG/VIALPOWDER / INTRAVENOUSAP2017-09-295c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A207092-002CASPOFUNGIN ACETATE70MG/VIALPOWDER / INTRAVENOUSAP2017-09-295c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A207092-001CASPOFUNGIN ACETATE50MG/VIALPOWDER / INTRAVENOUSAP2017-09-295d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A207092-002CASPOFUNGIN ACETATE70MG/VIALPOWDER / INTRAVENOUSAP2017-09-295d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A207092-001CASPOFUNGIN ACETATE50MG/VIALPOWDER / INTRAVENOUSAP2017-09-294b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A207092-002CASPOFUNGIN ACETATE70MG/VIALPOWDER / INTRAVENOUSAP2017-09-294b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A207092-001CASPOFUNGIN ACETATE50MG/VIALPOWDER / INTRAVENOUSAP2017-09-2974a2ff9319b5…
2019-12-13 00:20 UTC2019-12A207092-002CASPOFUNGIN ACETATE70MG/VIALPOWDER / INTRAVENOUSAP2017-09-2974a2ff9319b5…
2022-03-09 01:35 UTC2022-03A207092-001CASPOFUNGIN ACETATE50MG/VIALPOWDER / INTRAVENOUSAP2017-09-29bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A207092-002CASPOFUNGIN ACETATE70MG/VIALPOWDER / INTRAVENOUSAP2017-09-29bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A207092-001CASPOFUNGIN ACETATE50MG/VIALPOWDER / INTRAVENOUSAP2017-09-29782e0a99824c…
2021-12-28 21:50 UTC2021-12A207092-002CASPOFUNGIN ACETATE70MG/VIALPOWDER / INTRAVENOUSAP2017-09-29782e0a99824c…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A207092-001AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207092-002AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207092-001AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207092-002AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08A207092-001AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207092-002AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207092-001AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207092-002AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207092-001AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207092-002AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207092-001AP103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207092-002AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207092-001AP12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207092-002AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207092-001AP15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207092-002AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207092-001AP1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207092-002AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A207092-001AP1d06236e962d9…
2024-10-29 15:01 UTC2024-10A207092-002AP1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207092-001AP179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207092-002AP179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207092-001AP1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207092-002AP1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A207092-001AP11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A207092-002AP11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A207092-001AP18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A207092-002AP18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A207092-001AP15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A207092-002AP15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A207092-001AP15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A207092-002AP15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A207092-001AP14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A207092-002AP14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A207092-001AP174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A207092-002AP174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A207092-001AP1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A207092-002AP1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A207092-001AP1782e0a99824c…
2021-12-28 21:50 UTC2021-12A207092-002AP1782e0a99824c…

Additional Listing Data#

Finished product
Yes
Brand name base
Caspofungin Acetate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CASPOFUNGIN ACETATE7 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
VUW370O5QEInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
828539Internal RxNorm lookup
828755Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
cbd33696-e059-4e27-a782-95e23e8159b8Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
3e090fbd-2b26-41f0-87f0-76e9459efe59Product name320220317
48747306-602a-42cc-957b-5b0c69158eeeProduct name120180604
3e090fbd-2b26-41f0-87f0-76e9459efe59Product name120171121
db5ebcdb-b6ae-21cd-4dc5-76cd84b5578bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72266-107-01Caspofungin Acetate10 mL in 1 VIALINJECTION, POWDER, LYOPHILIZED,106
72266-107-01Caspofungin Acetate1 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72266-107-01EA - Each72266-107f356a9a0-a0c5-4734-aa26-f1e46d74c2e712019-08-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72266-107CASPOFUNGIN ACETATE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FOSUN PHARMA USA INC.]6Current NDC, Legacy NDC, 2 package rows20250423_cbd33696-e059-4e27-a782-95e23e8159b8.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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Caspofungin AcetateCASPOFUNGIN ACETATESagent Pharmaceuticals08fb61ee-a05a-4ce1-934c-8cd26c5733db2026-07-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207092
application number: ANDA207092
Caspofungin AcetateCASPOFUNGIN ACETATEFosun Pharma USA Inc.cbd33696-e059-4e27-a782-95e23e8159b82022-03-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207092
application number: ANDA207092
ndc (product): 72266-107
Caspofungin AcetateCASPOFUNGIN ACETATEGland Pharma Limited29da357e-e7fc-46af-bf20-806a1e4b53912022-01-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207092
application number: ANDA207092

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
828755caspofungin acetate 50 MG InjectionPSNcbd33696-e059-4e27-a782-95e23e8159b86
828539caspofungin acetate 70 MG InjectionPSNcbd33696-e059-4e27-a782-95e23e8159b86
828755caspofungin acetate 50 MG InjectionSCDcbd33696-e059-4e27-a782-95e23e8159b86
828539caspofungin acetate 70 MG InjectionSCDcbd33696-e059-4e27-a782-95e23e8159b86
828755caspofungin acetate 50 MG (equivalent to caspofungin 54.6 MG) InjectionSYcbd33696-e059-4e27-a782-95e23e8159b86
828539caspofungin acetate 70 MG (equivalent to caspofungin 75.6 MG) InjectionSYcbd33696-e059-4e27-a782-95e23e8159b86

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72266-107-01722660107011 VIAL in 1 CARTON (72266-107-01) / 10 mL in 1 VIAL1 vial2019-04-020000-00-00NoNoCurrent