FDA.reportPublic FDA data

CASPOFUNGIN ACETATE

Product NDC
0781-3421
11-digit product format
007813421
Labeler code
0781
Product ID
0781-3421_d70d52c0-6601-f632-e053-2995a90a9291
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
CASPOFUNGIN ACETATE
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Sandoz Inc
Application
ANDA200833
Marketing category
ANDA
Marketing start
2018-09-04
Substance
CASPOFUNGIN ACETATE
Active strength
5 mg/mL
Pharmacologic classes
Echinocandin Antifungal [EPC], Lipopeptides [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
CASPOFUNGIN ACETATE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CASPOFUNGIN ACETATE5 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiVUW370O5QE
Rxcui828539, 828755

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0781-3421-942021-08-03C16284748780-1c7ccaba7-1cc5-fd44-e053-dadaa90aa01bThese highlights do not include all the information needed to use CASPOFUNGIN ACETATE FOR INJECTION safely and effectively. See full prescribing information for CASPOFUNGIN ACETATE FOR INJECTION. CASPOFUNGIN ACETATE for injection, for intravenous use Initial U.S. Approval: 2001
0781-3421-942021-07-23C16284748780-1c7ccaba7-1cc5-fd44-e053-dadaa90aa01bThese highlights do not include all the information needed to use CASPOFUNGIN ACETATE FOR INJECTION safely and effectively. See full prescribing information for CASPOFUNGIN ACETATE FOR INJECTION. CASPOFUNGIN ACETATE for injection, for intravenous use Initial U.S. Approval: 2001

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0781-3421-01CASPOFUNGIN ACETATE10.8 mL in 1 VIAL, SINGLE-DOSEINJECTION, POWDER, LYOPHILIZED,10.86
0781-3421-94CASPOFUNGIN ACETATE1 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0781-3421-01EA - Each0781-34218f6189fe-49f1-4493-a4bf-5a349d18e94e12019-10-07
0781-3421-94EA - Each0781-342111ab6328-e4d0-4762-9274-4dbf392d8a0412018-12-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0781-3421CASPOFUNGIN ACETATE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [SANDOZ INC]6Current NDC, Legacy NDC, 2 package rows20220211_722facc6-d4ea-4975-b83e-3ae63df69ed2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
828755caspofungin acetate 50 MG InjectionPSN722facc6-d4ea-4975-b83e-3ae63df69ed26
828539caspofungin acetate 70 MG InjectionPSN722facc6-d4ea-4975-b83e-3ae63df69ed26
828755caspofungin acetate 50 MG InjectionSCD722facc6-d4ea-4975-b83e-3ae63df69ed26
828539caspofungin acetate 70 MG InjectionSCD722facc6-d4ea-4975-b83e-3ae63df69ed26
828755caspofungin acetate 50 MG (equivalent to caspofungin 54.6 MG) InjectionSY722facc6-d4ea-4975-b83e-3ae63df69ed26
828539caspofungin acetate 70 MG (equivalent to caspofungin 75.6 MG) InjectionSY722facc6-d4ea-4975-b83e-3ae63df69ed26

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0781-3421-010078134210110.8 mL in 1 VIAL, SINGLE-DOSE10.8 mlHistorical
0781-3421-94007813421941 VIAL, SINGLE-DOSE in 1 CARTON (0781-3421-94) / 10.8 mL in 1 VIAL, SINGLE-DOSE (0781-3421-01) 2018-09-040000-00-00NoNoCurrent