FDA.reportPublic FDA data

Caspofungin Acetate

Product NDC
25021-195
11-digit product format
250210195
Labeler code
25021
Product ID
25021-195_3a261cef-2cc8-457f-977b-56c21d865caf
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Caspofungin Acetate
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Sagent Pharmaceuticals
Application
ANDA207092
Marketing category
ANDA
Marketing start
2023-07-15
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

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 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
25021-195-10Caspofungin Acetate1 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,11
25021-195-10Caspofungin Acetate10 mL in 1 VIALINJECTION, POWDER, LYOPHILIZED,101

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
25021-195-10EA - Each25021-195e0ff97ee-4c6a-4eba-83cb-e09d3a01013612023-10-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
25021-195CASPOFUNGIN ACETATE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [SAGENT PHARMACEUTICALS]1Current NDC, 2 package rows20230715_08fb61ee-a05a-4ce1-934c-8cd26c5733db.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
828755caspofungin acetate 50 MG InjectionPSN08fb61ee-a05a-4ce1-934c-8cd26c5733db1
828539caspofungin acetate 70 MG InjectionPSN08fb61ee-a05a-4ce1-934c-8cd26c5733db1
828755caspofungin acetate 50 MG InjectionSCD08fb61ee-a05a-4ce1-934c-8cd26c5733db1
828539caspofungin acetate 70 MG InjectionSCD08fb61ee-a05a-4ce1-934c-8cd26c5733db1
828755caspofungin acetate 50 MG (equivalent to caspofungin 54.6 MG) InjectionSY08fb61ee-a05a-4ce1-934c-8cd26c5733db1
828539caspofungin acetate 70 MG (equivalent to caspofungin 75.6 MG) InjectionSY08fb61ee-a05a-4ce1-934c-8cd26c5733db1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
25021-195-10250210195101 VIAL in 1 CARTON (25021-195-10) / 10 mL in 1 VIAL1 vial2023-07-15NoNoHistorical