CANCIDAS

Product NDC
0006-3823
11-digit product format
000063823
Labeler code
0006
Product ID
0006-3823_415db552-7a2f-4881-9545-b7dd64816003
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
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
N021227-001CANCIDASCASPOFUNGIN ACETATE50MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**POWDER / INTRAVENOUSRLD2001-01-26
N021227-002CANCIDASCASPOFUNGIN ACETATE70MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**POWDER / INTRAVENOUSRLD2001-01-26

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 · 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 UTC2026-02N021227-001CANCIDAS50MG/VIALPOWDER / INTRAVENOUSRLD2001-01-26011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021227-002CANCIDAS70MG/VIALPOWDER / INTRAVENOUSRLD2001-01-26011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021227-001CANCIDAS50MG/VIALPOWDER / INTRAVENOUSRLD2001-01-2631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021227-002CANCIDAS70MG/VIALPOWDER / INTRAVENOUSRLD2001-01-2631067a03dcf5…
2025-08-23 18:47 UTC2025-08N021227-001CANCIDAS50MG/VIALPOWDER / INTRAVENOUSRLD2001-01-266a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021227-002CANCIDAS70MG/VIALPOWDER / INTRAVENOUSRLD2001-01-266a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021227-001CANCIDAS50MG/VIALPOWDER / INTRAVENOUSRLD2001-01-26fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021227-002CANCIDAS70MG/VIALPOWDER / INTRAVENOUSRLD2001-01-26fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021227-001CANCIDAS50MG/VIALPOWDER / INTRAVENOUSRLD2001-01-26b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021227-002CANCIDAS70MG/VIALPOWDER / INTRAVENOUSRLD2001-01-26b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021227-001CANCIDAS50MG/VIALPOWDER / INTRAVENOUSRLD2001-01-2603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021227-002CANCIDAS70MG/VIALPOWDER / INTRAVENOUSRLD2001-01-2603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021227-001CANCIDAS50MG/VIALPOWDER / INTRAVENOUSAPRLD, RS2001-01-262680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021227-002CANCIDAS70MG/VIALPOWDER / INTRAVENOUSAPRLD, RS2001-01-262680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021227-001CANCIDAS50MG/VIALPOWDER / INTRAVENOUSAPRLD, RS2001-01-265bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021227-002CANCIDAS70MG/VIALPOWDER / INTRAVENOUSAPRLD, RS2001-01-265bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021227-001CANCIDAS50MG/VIALPOWDER / INTRAVENOUSAPRLD, RS2001-01-26d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021227-002CANCIDAS70MG/VIALPOWDER / INTRAVENOUSAPRLD, RS2001-01-26d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N021227-001CANCIDAS50MG/VIALPOWDER / INTRAVENOUSAPRLD, RS2001-01-26d06236e962d9…
2024-10-29 15:01 UTC2024-10N021227-002CANCIDAS70MG/VIALPOWDER / INTRAVENOUSAPRLD, RS2001-01-26d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021227-001CANCIDAS50MG/VIALPOWDER / INTRAVENOUSAPRLD, RS2001-01-2679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021227-002CANCIDAS70MG/VIALPOWDER / INTRAVENOUSAPRLD, RS2001-01-2679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021227-001CANCIDAS50MG/VIALPOWDER / INTRAVENOUSAPRLD, RS2001-01-26301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021227-002CANCIDAS70MG/VIALPOWDER / INTRAVENOUSAPRLD, RS2001-01-26301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021227-001CANCIDAS50MG/VIALPOWDER / INTRAVENOUSAPRLD, RS2001-01-261e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021227-002CANCIDAS70MG/VIALPOWDER / INTRAVENOUSAPRLD, RS2001-01-261e350fbaab3a…
2024-05-31 18:47 UTC2024-05N021227-001CANCIDAS50MG/VIALPOWDER / INTRAVENOUSAPRLD, RS2001-01-268072bd15b7f6…
2024-05-31 18:47 UTC2024-05N021227-002CANCIDAS70MG/VIALPOWDER / INTRAVENOUSAPRLD, RS2001-01-268072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021227-001CANCIDAS50MG/VIALPOWDER / INTRAVENOUSAPRLD, RS2001-01-265c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021227-002CANCIDAS70MG/VIALPOWDER / INTRAVENOUSAPRLD, RS2001-01-265c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N021227-001CANCIDAS50MG/VIALPOWDER / INTRAVENOUSAPRLD, RS2001-01-265d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N021227-002CANCIDAS70MG/VIALPOWDER / INTRAVENOUSAPRLD, RS2001-01-265d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N021227-001CANCIDAS50MG/VIALPOWDER / INTRAVENOUSAPRLD, RS2001-01-264b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N021227-002CANCIDAS70MG/VIALPOWDER / INTRAVENOUSAPRLD, RS2001-01-264b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N021227-001CANCIDAS50MG/VIALPOWDER / INTRAVENOUSAPRLD, RS2001-01-2674a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021227-002CANCIDAS70MG/VIALPOWDER / INTRAVENOUSAPRLD, RS2001-01-2674a2ff9319b5…
2022-03-09 01:35 UTC2022-03N021227-001CANCIDAS50MG/VIALPOWDER / INTRAVENOUSAPRLD, RS2001-01-26bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N021227-002CANCIDAS70MG/VIALPOWDER / INTRAVENOUSAPRLD, RS2001-01-26bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N021227-001CANCIDAS50MG/VIALPOWDER / INTRAVENOUSAPRLD, RS2001-01-26782e0a99824c…
2021-12-28 21:50 UTC2021-12N021227-002CANCIDAS70MG/VIALPOWDER / INTRAVENOUSAPRLD, RS2001-01-26782e0a99824c…

Observed Orange Book normalized TE history#

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

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021227-001AP12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021227-002AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021227-001AP15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021227-002AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021227-001AP1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021227-002AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N021227-001AP1d06236e962d9…
2024-10-29 15:01 UTC2024-10N021227-002AP1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021227-001AP179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021227-002AP179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021227-001AP1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021227-002AP1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021227-001AP11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021227-002AP11e350fbaab3a…
2024-05-31 18:47 UTC2024-05N021227-001AP18072bd15b7f6…
2024-05-31 18:47 UTC2024-05N021227-002AP18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021227-001AP15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021227-002AP15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N021227-001AP15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N021227-002AP15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N021227-001AP14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N021227-002AP14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N021227-001AP174a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021227-002AP174a2ff9319b5…
2022-03-09 01:35 UTC2022-03N021227-001AP1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N021227-002AP1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N021227-001AP1782e0a99824c…
2021-12-28 21:50 UTC2021-12N021227-002AP1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N021227-001AP187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N021227-002AP187673890dc5c…
2021-03-12 10:30 UTC2021-03N021227-001AP15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03N021227-002AP15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N021227-001AP18869cabd3fbd…
2020-12-22 03:56 UTC2020-12N021227-002AP18869cabd3fbd…
2020-11-12 02:37 UTC2020-11N021227-001AP1c0c555d07b60…
2020-11-12 02:37 UTC2020-11N021227-002AP1c0c555d07b60…
2019-12-14 00:12 UTC2019-12N021227-001AP13f01610625f2…
2019-12-14 00:12 UTC2019-12N021227-002AP13f01610625f2…
2019-09-15 20:21 UTC2019-09N021227-001AP1b00525d2431f…
2019-09-15 20:21 UTC2019-09N021227-002AP1b00525d2431f…

Additional Listing Data#

Finished product
Yes
Brand name base
CANCIDAS
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 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
828539Internal RxNorm lookup
828541Internal RxNorm lookup
828755Internal RxNorm lookup
828757Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
3bad23a6-09a6-4194-9182-093ed61bc71cAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
3e090fbd-2b26-41f0-87f0-76e9459efe59Product name320220317
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
48747306-602a-42cc-957b-5b0c69158eeeProduct name120180604
3e090fbd-2b26-41f0-87f0-76e9459efe59Product name120171121
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508
db5ebcdb-b6ae-21cd-4dc5-76cd84b5578bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0006-3823-10CANCIDAS1 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,141
0006-3823-10CANCIDAS10.8 mL in 1 VIAL, SINGLE-USEINJECTION, POWDER, LYOPHILIZED,10.841

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0006-3823-10EA - Each0006-3823290e6d53-e3d3-4fb6-a85c-4ddd1be7caf612012-07-24

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0006-3823CANCIDAS (CASPOFUNGIN ACETATE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MERCK SHARP & DOHME LLC]40Current NDC, Legacy NDC, 2 package rows20241018_3bad23a6-09a6-4194-9182-093ed61bc71c.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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CANCIDASCASPOFUNGIN ACETATEMerck Sharp & Dohme LLC3bad23a6-09a6-4194-9182-093ed61bc71c2024-10-11Warnings, Adverse reactionsExact identifier
application applno (NDA): 021227
application number: NDA021227
ndc (product): 0006-3823

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
828757Cancidas 50 MG InjectionPSN3bad23a6-09a6-4194-9182-093ed61bc71c41
828541Cancidas 70 MG InjectionPSN3bad23a6-09a6-4194-9182-093ed61bc71c41
828755caspofungin acetate 50 MG InjectionPSN3bad23a6-09a6-4194-9182-093ed61bc71c41
828539caspofungin acetate 70 MG InjectionPSN3bad23a6-09a6-4194-9182-093ed61bc71c41
828757caspofungin acetate 50 MG Injection [Cancidas]SBD3bad23a6-09a6-4194-9182-093ed61bc71c41
828541caspofungin acetate 70 MG Injection [Cancidas]SBD3bad23a6-09a6-4194-9182-093ed61bc71c41
828755caspofungin acetate 50 MG InjectionSCD3bad23a6-09a6-4194-9182-093ed61bc71c41
828539caspofungin acetate 70 MG InjectionSCD3bad23a6-09a6-4194-9182-093ed61bc71c41
828757Cancidas 50 MG (equivalent to caspofungin 54.6 MG) InjectionSY3bad23a6-09a6-4194-9182-093ed61bc71c41
828757Cancidas 50 MG InjectionSY3bad23a6-09a6-4194-9182-093ed61bc71c41
828541Cancidas 70 MG (equivalent to caspofungin 75.6 MG) InjectionSY3bad23a6-09a6-4194-9182-093ed61bc71c41
828541Cancidas 70 MG InjectionSY3bad23a6-09a6-4194-9182-093ed61bc71c41
828755caspofungin acetate 50 MG (equivalent to caspofungin 54.6 MG) InjectionSY3bad23a6-09a6-4194-9182-093ed61bc71c41
828539caspofungin acetate 70 MG (equivalent to caspofungin 75.6 MG) InjectionSY3bad23a6-09a6-4194-9182-093ed61bc71c41

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0006-3823-10000063823101 VIAL, SINGLE-USE in 1 CARTON (0006-3823-10) / 10.8 mL in 1 VIAL, SINGLE-USE2001-01-260000-00-00NoNoCurrent