FDA.reportPublic FDA data

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

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
A216506-001CASPOFUNGIN ACETATECASPOFUNGIN ACETATE50MG/VIALPOWDER / INTRAVENOUSAP2025-07-18
A216506-002CASPOFUNGIN ACETATECASPOFUNGIN ACETATE70MG/VIALPOWDER / INTRAVENOUSAP2025-07-18

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A216506-001AP
A216506-002AP

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A216506-001CASPOFUNGIN ACETATE50MG/VIALPOWDER / INTRAVENOUSAP2025-07-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02A216506-002CASPOFUNGIN ACETATE70MG/VIALPOWDER / INTRAVENOUSAP2025-07-18011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A216506-001CASPOFUNGIN ACETATE50MG/VIALPOWDER / INTRAVENOUSAP2025-07-1831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A216506-002CASPOFUNGIN ACETATE70MG/VIALPOWDER / INTRAVENOUSAP2025-07-1831067a03dcf5…
2025-08-23 18:47 UTC2025-08A216506-001CASPOFUNGIN ACETATE50MG/VIALPOWDER / INTRAVENOUSAP2025-07-186a471c1ec25d…
2025-08-23 18:47 UTC2025-08A216506-002CASPOFUNGIN ACETATE70MG/VIALPOWDER / INTRAVENOUSAP2025-07-186a471c1ec25d…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A216506-001CASPOFUNGIN ACETATE50MG/VIALPOWDER / INTRAVENOUSAP2025-07-18a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A216506-002CASPOFUNGIN ACETATE70MG/VIALPOWDER / INTRAVENOUSAP2025-07-18a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A216506-001AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A216506-002AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A216506-001AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A216506-002AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08A216506-001AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A216506-002AP16a471c1ec25d…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A216506-001AP1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A216506-002AP1a50c72e98297…

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 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 · 2 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
2b9bf716-9d4b-4264-985b-6fe98f5e729dAvailable 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
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

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
CASPOFUNGIN ACETATECASPOFUNGIN ACETATEHangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.2b9bf716-9d4b-4264-985b-6fe98f5e729d2025-10-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 216506
application number: ANDA216506
ndc (product): 65897-0002

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