Home NDC 63323-358 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 Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N206110-001 CASPOFUNGIN ACETATE CASPOFUNGIN ACETATE 50MG/VIAL POWDER / INTRAVENOUS AP 2016-12-30 N206110-002 CASPOFUNGIN ACETATE CASPOFUNGIN ACETATE 70MG/VIAL POWDER / INTRAVENOUS AP 2016-12-30
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
Orange Book patents# Current patent rows page 1 of 1 · 2 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N206110-001 9636407 2032-12-21 Drug product 2017-05-10 N206110-002 9636407 2032-12-21 Drug product 2017-05-10
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.
Product history page 1 of 3 · 84 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-18 06:07:40 2026-07 N206110-001 CASPOFUNGIN ACETATE 50MG/VIAL POWDER / INTRAVENOUS AP 2016-12-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N206110-002 CASPOFUNGIN ACETATE 70MG/VIAL POWDER / INTRAVENOUS AP 2016-12-30 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N206110-001 CASPOFUNGIN ACETATE 50MG/VIAL POWDER / INTRAVENOUS AP 2016-12-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N206110-002 CASPOFUNGIN ACETATE 70MG/VIAL POWDER / INTRAVENOUS AP 2016-12-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N206110-001 CASPOFUNGIN ACETATE 50MG/VIAL POWDER / INTRAVENOUS AP 2016-12-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N206110-002 CASPOFUNGIN ACETATE 70MG/VIAL POWDER / INTRAVENOUS AP 2016-12-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N206110-001 CASPOFUNGIN ACETATE 50MG/VIAL POWDER / INTRAVENOUS AP 2016-12-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N206110-002 CASPOFUNGIN ACETATE 70MG/VIAL POWDER / INTRAVENOUS AP 2016-12-30 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N206110-001 CASPOFUNGIN ACETATE 50MG/VIAL POWDER / INTRAVENOUS AP 2016-12-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N206110-002 CASPOFUNGIN ACETATE 70MG/VIAL POWDER / INTRAVENOUS AP 2016-12-30 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N206110-001 CASPOFUNGIN ACETATE 50MG/VIAL POWDER / INTRAVENOUS AP 2016-12-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N206110-002 CASPOFUNGIN ACETATE 70MG/VIAL POWDER / INTRAVENOUS AP 2016-12-30 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N206110-001 CASPOFUNGIN ACETATE 50MG/VIAL POWDER / INTRAVENOUS AP 2016-12-30 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N206110-002 CASPOFUNGIN ACETATE 70MG/VIAL POWDER / INTRAVENOUS AP 2016-12-30 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N206110-001 CASPOFUNGIN ACETATE 50MG/VIAL POWDER / INTRAVENOUS AP 2016-12-30 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N206110-002 CASPOFUNGIN ACETATE 70MG/VIAL POWDER / INTRAVENOUS AP 2016-12-30 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N206110-001 CASPOFUNGIN ACETATE 50MG/VIAL POWDER / INTRAVENOUS AP 2016-12-30 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N206110-002 CASPOFUNGIN ACETATE 70MG/VIAL POWDER / INTRAVENOUS AP 2016-12-30 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N206110-001 CASPOFUNGIN ACETATE 50MG/VIAL POWDER / INTRAVENOUS AP 2016-12-30 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N206110-002 CASPOFUNGIN ACETATE 70MG/VIAL POWDER / INTRAVENOUS AP 2016-12-30 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N206110-001 CASPOFUNGIN ACETATE 50MG/VIAL POWDER / INTRAVENOUS AP 2016-12-30 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N206110-002 CASPOFUNGIN ACETATE 70MG/VIAL POWDER / INTRAVENOUS AP 2016-12-30 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N206110-001 CASPOFUNGIN ACETATE 50MG/VIAL POWDER / INTRAVENOUS AP 2016-12-30 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N206110-002 CASPOFUNGIN ACETATE 70MG/VIAL POWDER / INTRAVENOUS AP 2016-12-30 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N206110-001 CASPOFUNGIN ACETATE 50MG/VIAL POWDER / INTRAVENOUS AP 2016-12-30 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N206110-002 CASPOFUNGIN ACETATE 70MG/VIAL POWDER / INTRAVENOUS AP 2016-12-30 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N206110-001 CASPOFUNGIN ACETATE 50MG/VIAL POWDER / INTRAVENOUS AP 2016-12-30 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N206110-002 CASPOFUNGIN ACETATE 70MG/VIAL POWDER / INTRAVENOUS AP 2016-12-30 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N206110-001 CASPOFUNGIN ACETATE 50MG/VIAL POWDER / INTRAVENOUS AP 2016-12-30 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N206110-002 CASPOFUNGIN ACETATE 70MG/VIAL POWDER / INTRAVENOUS AP 2016-12-30 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N206110-001 CASPOFUNGIN ACETATE 50MG/VIAL POWDER / INTRAVENOUS AP 2016-12-30 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N206110-002 CASPOFUNGIN ACETATE 70MG/VIAL POWDER / INTRAVENOUS AP 2016-12-30 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N206110-001 CASPOFUNGIN ACETATE 50MG/VIAL POWDER / INTRAVENOUS AP 2016-12-30 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N206110-002 CASPOFUNGIN ACETATE 70MG/VIAL POWDER / INTRAVENOUS AP 2016-12-30 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N206110-001 CASPOFUNGIN ACETATE 50MG/VIAL POWDER / INTRAVENOUS AP 2016-12-30 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N206110-002 CASPOFUNGIN ACETATE 70MG/VIAL POWDER / INTRAVENOUS AP 2016-12-30 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N206110-001 CASPOFUNGIN ACETATE 50MG/VIAL POWDER / INTRAVENOUS AP 2016-12-30 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N206110-002 CASPOFUNGIN ACETATE 70MG/VIAL POWDER / INTRAVENOUS AP 2016-12-30 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N206110-001 CASPOFUNGIN ACETATE 50MG/VIAL POWDER / INTRAVENOUS AP 2016-12-30 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N206110-002 CASPOFUNGIN ACETATE 70MG/VIAL POWDER / INTRAVENOUS AP 2016-12-30 bb7c543d1eb4…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 84 observed states.
Observed Orange Book patent history# Patent history page 1 of 3 · 84 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-08-18 06:07:40 2026-07 N206110-001 9636407 2032-12-21 Drug product 2017-05-10 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N206110-002 9636407 2032-12-21 Drug product 2017-05-10 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N206110-001 9636407 2032-12-21 Drug product 2017-05-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N206110-002 9636407 2032-12-21 Drug product 2017-05-10 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N206110-001 9636407 2032-12-21 Drug product 2017-05-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N206110-002 9636407 2032-12-21 Drug product 2017-05-10 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N206110-001 9636407 2032-12-21 Drug product 2017-05-10 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N206110-002 9636407 2032-12-21 Drug product 2017-05-10 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N206110-001 9636407 2032-12-21 Drug product 2017-05-10 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N206110-002 9636407 2032-12-21 Drug product 2017-05-10 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N206110-001 9636407 2032-12-21 Drug product 2017-05-10 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N206110-002 9636407 2032-12-21 Drug product 2017-05-10 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N206110-001 9636407 2032-12-21 Drug product 2017-05-10 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N206110-002 9636407 2032-12-21 Drug product 2017-05-10 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N206110-001 9636407 2032-12-21 Drug product 2017-05-10 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N206110-002 9636407 2032-12-21 Drug product 2017-05-10 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N206110-001 9636407 2032-12-21 Drug product 2017-05-10 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N206110-002 9636407 2032-12-21 Drug product 2017-05-10 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N206110-001 9636407 2032-12-21 Drug product 2017-05-10 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N206110-002 9636407 2032-12-21 Drug product 2017-05-10 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N206110-001 9636407 2032-12-21 Drug product 2017-05-10 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N206110-002 9636407 2032-12-21 Drug product 2017-05-10 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N206110-001 9636407 2032-12-21 Drug product 2017-05-10 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N206110-002 9636407 2032-12-21 Drug product 2017-05-10 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N206110-001 9636407 2032-12-21 Drug product 2017-05-10 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N206110-002 9636407 2032-12-21 Drug product 2017-05-10 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N206110-001 9636407 2032-12-21 Drug product 2017-05-10 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N206110-002 9636407 2032-12-21 Drug product 2017-05-10 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N206110-001 9636407 2032-12-21 Drug product 2017-05-10 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N206110-002 9636407 2032-12-21 Drug product 2017-05-10 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N206110-001 9636407 2032-12-21 Drug product 2017-05-10 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N206110-002 9636407 2032-12-21 Drug product 2017-05-10 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N206110-001 9636407 2032-12-21 Drug product 2017-05-10 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N206110-002 9636407 2032-12-21 Drug product 2017-05-10 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N206110-001 9636407 2032-12-21 Drug product 2017-05-10 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N206110-002 9636407 2032-12-21 Drug product 2017-05-10 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N206110-001 9636407 2032-12-21 Drug product 2017-05-10 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N206110-002 9636407 2032-12-21 Drug product 2017-05-10 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N206110-001 9636407 2032-12-21 Drug product 2017-05-10 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N206110-002 9636407 2032-12-21 Drug product 2017-05-10 bb7c543d1eb4…
Additional Listing Data#
Finished product Yes
Brand name base Caspofungin Acetate
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CASPOFUNGIN ACETATE 7 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination VUW370O5QE Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 828539 Internal RxNorm lookup 828755 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 63323-358-01 Caspofungin Acetate 10.8 mL in 1 VIAL, SINGLE-DOSE INJECTION, POWDER, LYOPHILIZED, 10.8 7 63323-358-10 Caspofungin Acetate 10 in 1 CARTON INJECTION, POWDER, LYOPHILIZED, 10 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63323-358 CASPOFUNGIN ACETATE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC
] 6 Current NDC, Legacy NDC, 2 package rows 20211007_e76d8d83-3691-451c-a32c-d91448c54d16.zip
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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 63323-358-01 63323035801 10.8 mL in 1 VIAL, SINGLE-DOSE 10.8 ml Historical 63323-358-10 63323035810 10 VIAL, SINGLE-DOSE in 1 CARTON (63323-358-10) / 10.8 mL in 1 VIAL, SINGLE-DOSE (63323-358-01) 2016-12-30 0000-00-00 No No Current