FDA.reportPublic FDA data

Caspofungin Acetate

Product NDC
63323-358
11-digit product format
633230358
Labeler code
63323
Product ID
63323-358_7cdf103b-418f-42a8-bd1b-ebfd8027124a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Caspofungin Acetate
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Fresenius Kabi USA, LLC
Application
NDA206110
Marketing category
NDA
Marketing start
2016-12-30
Substance
CASPOFUNGIN ACETATE
Active strength
7 mg/mL
Pharmacologic classes
Echinocandin Antifungal [EPC], Lipopeptides [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Caspofungin Acetate
Listing expiration
2027-12-31

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
3e090fbd-2b26-41f0-87f0-76e9459efe59Product name120171121
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
1681bc73-b05f-12c3-1075-382ae39f449cProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63323-358-01Caspofungin Acetate10.8 mL in 1 VIAL, SINGLE-DOSEINJECTION, POWDER, LYOPHILIZED,10.87
63323-358-10Caspofungin Acetate10 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,107

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63323-358-01EA - Each63323-3587e16306c-89c2-4448-9e37-b6e773f7262612019-10-07
63323-358-10EA - Each63323-3582e989d7b-93cf-4ef0-9acd-5fd9787b4f9412017-08-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63323-358CASPOFUNGIN ACETATE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC ]6Current NDC, Legacy NDC, 2 package rows20211007_e76d8d83-3691-451c-a32c-d91448c54d16.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
828755caspofungin acetate 50 MG InjectionPSNe76d8d83-3691-451c-a32c-d91448c54d167
828539caspofungin acetate 70 MG InjectionPSNe76d8d83-3691-451c-a32c-d91448c54d167
828755caspofungin acetate 50 MG InjectionSCDe76d8d83-3691-451c-a32c-d91448c54d167
828539caspofungin acetate 70 MG InjectionSCDe76d8d83-3691-451c-a32c-d91448c54d167
828755caspofungin acetate 50 MG (equivalent to caspofungin 54.6 MG) InjectionSYe76d8d83-3691-451c-a32c-d91448c54d167
828539caspofungin acetate 70 MG (equivalent to caspofungin 75.6 MG) InjectionSYe76d8d83-3691-451c-a32c-d91448c54d167

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63323-358-016332303580110.8 mL in 1 VIAL, SINGLE-DOSE10.8 mlHistorical
63323-358-106332303581010 VIAL, SINGLE-DOSE in 1 CARTON (63323-358-10) / 10.8 mL in 1 VIAL, SINGLE-DOSE (63323-358-01) 2016-12-300000-00-00NoNoCurrent