CASPOFUNGIN ACETATE

Product NDC
65897-0002
11-digit product format
658970002
Labeler code
65897
Product ID
65897-0002_3fff89e8-9783-89fd-e063-6394a90a26ff
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
CASPOFUNGIN ACETATE
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.
Application
ANDA216506
Marketing category
ANDA
Marketing start
2025-08-26
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
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
65897-0002-1CASPOFUNGIN ACETATE10.8 mL in 1 VIAL, SINGLE-DOSEINJECTION, POWDER, LYOPHILIZED,10.83
65897-0002-1CASPOFUNGIN ACETATE1 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,13

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
828755caspofungin acetate 50 MG InjectionPSN2b9bf716-9d4b-4264-985b-6fe98f5e729d3
828539caspofungin acetate 70 MG InjectionPSN2b9bf716-9d4b-4264-985b-6fe98f5e729d3
828755caspofungin acetate 50 MG InjectionSCD2b9bf716-9d4b-4264-985b-6fe98f5e729d3
828539caspofungin acetate 70 MG InjectionSCD2b9bf716-9d4b-4264-985b-6fe98f5e729d3
828755caspofungin acetate 50 MG (equivalent to caspofungin 54.6 MG) InjectionSY2b9bf716-9d4b-4264-985b-6fe98f5e729d3
828539caspofungin acetate 70 MG (equivalent to caspofungin 75.6 MG) InjectionSY2b9bf716-9d4b-4264-985b-6fe98f5e729d3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
65897-0002-1658970002011 VIAL, SINGLE-DOSE in 1 CARTON (65897-0002-1) / 10.8 mL in 1 VIAL, SINGLE-DOSE2025-08-26NoNoCurrent