CARMUSTINE

Product NDC
50742-492
11-digit product format
507420492
Labeler code
50742
Product ID
50742-492_84fba3be-e8ed-4453-ba84-7719c3311e55
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
carmustine
Dosage form
KIT
Labeler
Ingenus Pharmaceuticals, LLC
Application
ANDA211011
Marketing category
ANDA
Marketing start
2022-06-25
Marketing end
0000-00-00
Active strength
0
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct50742-492DDiscontinued by firm2026-08-07
excluded packagepackage50742-49250742-492-01DDiscontinued by firm2026-08-07

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 24 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage50742-492-01d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage50742-492-01f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage50742-492-012ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage50742-492-01a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage50742-492-01cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage50742-492-01cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage50742-492-01302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage50742-492-01ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage50742-492-010efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage50742-492-01ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage50742-492-01367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage50742-492-01557ba5c1ecfa…9c80585c8c6e…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A211011-001CARMUSTINECARMUSTINE100MG/VIALINJECTABLE / INJECTION2022-06-21

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 UTC2026-02A211011-001CARMUSTINE100MG/VIALINJECTABLE / INJECTION2022-06-21011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211011-001CARMUSTINE100MG/VIALINJECTABLE / INJECTION2022-06-2131067a03dcf5…
2025-08-23 18:47 UTC2025-08A211011-001CARMUSTINE100MG/VIALINJECTABLE / INJECTION2022-06-216a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211011-001CARMUSTINE100MG/VIALINJECTABLE / INJECTION2022-06-21fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211011-001CARMUSTINE100MG/VIALINJECTABLE / INJECTION2022-06-21b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211011-001CARMUSTINE100MG/VIALINJECTABLE / INJECTION2022-06-2103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211011-001CARMUSTINE100MG/VIALINJECTABLE / INJECTION2022-06-212680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211011-001CARMUSTINE100MG/VIALINJECTABLE / INJECTION2022-06-215bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A211011-001CARMUSTINE100MG/VIALINJECTABLE / INJECTION2022-06-21d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A211011-001CARMUSTINE100MG/VIALINJECTABLE / INJECTION2022-06-21d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A211011-001CARMUSTINE100MG/VIALINJECTABLE / INJECTION2022-06-2179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A211011-001CARMUSTINE100MG/VIALINJECTABLE / INJECTION2022-06-21301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A211011-001CARMUSTINE100MG/VIALINJECTABLE / INJECTION2022-06-211e350fbaab3a…
2024-05-31 18:47 UTC2024-05A211011-001CARMUSTINE100MG/VIALINJECTABLE / INJECTION2022-06-218072bd15b7f6…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A211011-001CARMUSTINE100MG/VIALINJECTABLE / INJECTION2022-06-216a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A211011-001CARMUSTINE100MG/VIALINJECTABLE / INJECTIONAP2022-06-211c564ffb4f44…
2023-12-20 04:57 UTC2023-12A211011-001CARMUSTINE100MG/VIALINJECTABLE / INJECTIONAP2022-06-21ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A211011-001CARMUSTINE100MG/VIALINJECTABLE / INJECTIONAP2022-06-21a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A211011-001CARMUSTINE100MG/VIALINJECTABLE / INJECTIONAP2022-06-219b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A211011-001CARMUSTINE100MG/VIALINJECTABLE / INJECTIONAP2022-06-21a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A211011-001CARMUSTINE100MG/VIALINJECTABLE / INJECTIONAP2022-06-213f0d92c62455…
2023-05-13 08:27 UTC2023-05A211011-001CARMUSTINE100MG/VIALINJECTABLE / INJECTIONAP2022-06-21053a50430f4f…
2023-01-26 05:58 UTC2023-01A211011-001CARMUSTINE100MG/VIALINJECTABLE / INJECTIONAP2022-06-213bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A211011-001CARMUSTINE100MG/VIALINJECTABLE / INJECTIONAP2022-06-213a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A211011-001CARMUSTINE100MG/VIALINJECTABLE / INJECTIONAP2022-06-21f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A211011-001CARMUSTINE100MG/VIALINJECTABLE / INJECTIONAP2022-06-21e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A211011-001CARMUSTINE100MG/VIALINJECTABLE / INJECTIONAP2022-06-21cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A211011-001CARMUSTINE100MG/VIALINJECTABLE / INJECTION2022-06-21a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2024-02-18 07:12 UTC2024-02A211011-001AP11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A211011-001AP1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A211011-001AP1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A211011-001AP19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A211011-001AP1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A211011-001AP13f0d92c62455…
2023-05-13 08:27 UTC2023-05A211011-001AP1053a50430f4f…
2023-01-26 05:58 UTC2023-01A211011-001AP13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A211011-001AP13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A211011-001AP1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A211011-001AP1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A211011-001AP1cb3db0bc1861…

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50742-492-01507420492011 KIT in 1 CARTON (50742-492-01) * 30 mL in 1 VIAL, SINGLE-DOSE (50742-490-01) * 3 mL in 1 VIAL (50742-491-03) 1 kit2022-06-250000-00-00NoNoCurrent