CASPOFUNGIN ACETATE

Product NDC
72843-434
11-digit product format
728430434
Labeler code
72843
Product ID
72843-434_cd961d6c-beed-d6a3-e053-2a95a90a5b86
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
CASPOFUNGIN ACETATE
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS
Labeler
UBI Pharma Inc.
Application
ANDA211263
Marketing category
ANDA
Marketing start
2021-10-01
Marketing end
0000-00-00
Substance
CASPOFUNGIN ACETATE
Active strength
5 mg/mL
Pharmacologic classes
Lipopeptides [CS],Echinocandin Antifungal [EPC]
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

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
A211263-001CASPOFUNGIN ACETATECASPOFUNGIN ACETATE50MG/VIALPOWDER / INTRAVENOUSAP2021-10-01
A211263-002CASPOFUNGIN ACETATECASPOFUNGIN ACETATE70MG/VIALPOWDER / INTRAVENOUSAP2021-10-01

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A211263-001AP
A211263-002AP

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.

Product history page 1 of 2 · 66 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A211263-001CASPOFUNGIN ACETATE50MG/VIALPOWDER / INTRAVENOUSAP2021-10-01011fe1cb6892…
2026-02-19 14:30 UTC2026-02A211263-002CASPOFUNGIN ACETATE70MG/VIALPOWDER / INTRAVENOUSAP2021-10-01011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211263-001CASPOFUNGIN ACETATE50MG/VIALPOWDER / INTRAVENOUSAP2021-10-0131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211263-002CASPOFUNGIN ACETATE70MG/VIALPOWDER / INTRAVENOUSAP2021-10-0131067a03dcf5…
2025-08-23 18:47 UTC2025-08A211263-001CASPOFUNGIN ACETATE50MG/VIALPOWDER / INTRAVENOUSAP2021-10-016a471c1ec25d…
2025-08-23 18:47 UTC2025-08A211263-002CASPOFUNGIN ACETATE70MG/VIALPOWDER / INTRAVENOUSAP2021-10-016a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211263-001CASPOFUNGIN ACETATE50MG/VIALPOWDER / INTRAVENOUSAP2021-10-01fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211263-002CASPOFUNGIN ACETATE70MG/VIALPOWDER / INTRAVENOUSAP2021-10-01fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211263-001CASPOFUNGIN ACETATE50MG/VIALPOWDER / INTRAVENOUSAP2021-10-01b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211263-002CASPOFUNGIN ACETATE70MG/VIALPOWDER / INTRAVENOUSAP2021-10-01b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211263-001CASPOFUNGIN ACETATE50MG/VIALPOWDER / INTRAVENOUSAP2021-10-0103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211263-002CASPOFUNGIN ACETATE70MG/VIALPOWDER / INTRAVENOUSAP2021-10-0103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211263-001CASPOFUNGIN ACETATE50MG/VIALPOWDER / INTRAVENOUSAP2021-10-012680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211263-002CASPOFUNGIN ACETATE70MG/VIALPOWDER / INTRAVENOUSAP2021-10-012680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211263-001CASPOFUNGIN ACETATE50MG/VIALPOWDER / INTRAVENOUSAP2021-10-015bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211263-002CASPOFUNGIN ACETATE70MG/VIALPOWDER / INTRAVENOUSAP2021-10-015bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A211263-001CASPOFUNGIN ACETATE50MG/VIALPOWDER / INTRAVENOUSAP2021-10-01d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A211263-002CASPOFUNGIN ACETATE70MG/VIALPOWDER / INTRAVENOUSAP2021-10-01d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A211263-001CASPOFUNGIN ACETATE50MG/VIALPOWDER / INTRAVENOUSAP2021-10-01d06236e962d9…
2024-10-29 15:01 UTC2024-10A211263-002CASPOFUNGIN ACETATE70MG/VIALPOWDER / INTRAVENOUSAP2021-10-01d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A211263-001CASPOFUNGIN ACETATE50MG/VIALPOWDER / INTRAVENOUSAP2021-10-0179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A211263-002CASPOFUNGIN ACETATE70MG/VIALPOWDER / INTRAVENOUSAP2021-10-0179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A211263-001CASPOFUNGIN ACETATE50MG/VIALPOWDER / INTRAVENOUSAP2021-10-01301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A211263-002CASPOFUNGIN ACETATE70MG/VIALPOWDER / INTRAVENOUSAP2021-10-01301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A211263-001CASPOFUNGIN ACETATE50MG/VIALPOWDER / INTRAVENOUSAP2021-10-011e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A211263-002CASPOFUNGIN ACETATE70MG/VIALPOWDER / INTRAVENOUSAP2021-10-011e350fbaab3a…
2024-05-31 18:47 UTC2024-05A211263-001CASPOFUNGIN ACETATE50MG/VIALPOWDER / INTRAVENOUSAP2021-10-018072bd15b7f6…
2024-05-31 18:47 UTC2024-05A211263-002CASPOFUNGIN ACETATE70MG/VIALPOWDER / INTRAVENOUSAP2021-10-018072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A211263-001CASPOFUNGIN ACETATE50MG/VIALPOWDER / INTRAVENOUSAP2021-10-015c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A211263-002CASPOFUNGIN ACETATE70MG/VIALPOWDER / INTRAVENOUSAP2021-10-015c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A211263-001CASPOFUNGIN ACETATE50MG/VIALPOWDER / INTRAVENOUSAP2021-10-015d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A211263-002CASPOFUNGIN ACETATE70MG/VIALPOWDER / INTRAVENOUSAP2021-10-015d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A211263-001CASPOFUNGIN ACETATE50MG/VIALPOWDER / INTRAVENOUSAP2021-10-014b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A211263-002CASPOFUNGIN ACETATE70MG/VIALPOWDER / INTRAVENOUSAP2021-10-014b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A211263-001CASPOFUNGIN ACETATE50MG/VIALPOWDER / INTRAVENOUSAP2021-10-01bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A211263-002CASPOFUNGIN ACETATE70MG/VIALPOWDER / INTRAVENOUSAP2021-10-01bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A211263-001CASPOFUNGIN ACETATE50MG/VIALPOWDER / INTRAVENOUSAP2021-10-01782e0a99824c…
2021-12-28 21:50 UTC2021-12A211263-002CASPOFUNGIN ACETATE70MG/VIALPOWDER / INTRAVENOUSAP2021-10-01782e0a99824c…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A211263-001CASPOFUNGIN ACETATE50MG/VIALPOWDER / INTRAVENOUSAP2021-10-016a51e52b5d6a…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A211263-002CASPOFUNGIN ACETATE70MG/VIALPOWDER / INTRAVENOUSAP2021-10-016a51e52b5d6a…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 66 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A211263-001AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A211263-002AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211263-001AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211263-002AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08A211263-001AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A211263-002AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211263-001AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211263-002AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211263-001AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211263-002AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211263-001AP103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211263-002AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211263-001AP12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211263-002AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211263-001AP15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211263-002AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A211263-001AP1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A211263-002AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A211263-001AP1d06236e962d9…
2024-10-29 15:01 UTC2024-10A211263-002AP1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A211263-001AP179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A211263-002AP179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A211263-001AP1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A211263-002AP1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A211263-001AP11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A211263-002AP11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A211263-001AP18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A211263-002AP18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A211263-001AP15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A211263-002AP15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A211263-001AP15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A211263-002AP15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A211263-001AP14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A211263-002AP14b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A211263-001AP1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A211263-002AP1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A211263-001AP1782e0a99824c…
2021-12-28 21:50 UTC2021-12A211263-002AP1782e0a99824c…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A211263-001AP16a51e52b5d6a…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A211263-002AP16a51e52b5d6a…

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
72843-434-01728430434011 VIAL, SINGLE-DOSE in 1 CARTON (72843-434-01) > 10.8 mL in 1 VIAL, SINGLE-DOSE2021-10-010000-00-00NoNoCurrent