Home NDC 54879-036-64 Carmustine
Product NDC 54879-036
Requested package NDC 54879-036-64
11-digit product format 548790036
Labeler code 54879
Product ID 54879-036_edaba575-f99e-f561-e053-2995a90a41e7
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Carmustine
Dosage form KIT
Labeler STI Pharma LLC
Application ANDA209278
Marketing category ANDA
Marketing start 2019-05-16
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 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 · 15 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Code, Status table Captured / source date Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 I Inactivated by FDA 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 I Inactivated by FDA ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 I Inactivated by FDA 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 I Inactivated by FDA ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 I Inactivated by FDA 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 I Inactivated by FDA 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 I Inactivated by FDA 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 I Inactivated by FDA 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 I Inactivated by FDA 1332a3947898…d4bfe170f9cd…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A209278-001 CARMUSTINE CARMUSTINE 100MG/VIAL INJECTABLE / INJECTION AP 2019-04-02
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A209278-001 AP
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 · 42 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 A209278-001 CARMUSTINE 100MG/VIAL INJECTABLE / INJECTION AP 2019-04-02 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A209278-001 CARMUSTINE 100MG/VIAL INJECTABLE / INJECTION AP 2019-04-02 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A209278-001 CARMUSTINE 100MG/VIAL INJECTABLE / INJECTION AP 2019-04-02 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A209278-001 CARMUSTINE 100MG/VIAL INJECTABLE / INJECTION AP 2019-04-02 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A209278-001 CARMUSTINE 100MG/VIAL INJECTABLE / INJECTION AP 2019-04-02 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A209278-001 CARMUSTINE 100MG/VIAL INJECTABLE / INJECTION AP 2019-04-02 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A209278-001 CARMUSTINE 100MG/VIAL INJECTABLE / INJECTION AP 2019-04-02 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A209278-001 CARMUSTINE 100MG/VIAL INJECTABLE / INJECTION AP 2019-04-02 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A209278-001 CARMUSTINE 100MG/VIAL INJECTABLE / INJECTION AP 2019-04-02 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A209278-001 CARMUSTINE 100MG/VIAL INJECTABLE / INJECTION AP 2019-04-02 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A209278-001 CARMUSTINE 100MG/VIAL INJECTABLE / INJECTION AP 2019-04-02 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A209278-001 CARMUSTINE 100MG/VIAL INJECTABLE / INJECTION AP 2019-04-02 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A209278-001 CARMUSTINE 100MG/VIAL INJECTABLE / INJECTION AP 2019-04-02 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A209278-001 CARMUSTINE 100MG/VIAL INJECTABLE / INJECTION AP 2019-04-02 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A209278-001 CARMUSTINE 100MG/VIAL INJECTABLE / INJECTION AP 2019-04-02 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A209278-001 CARMUSTINE 100MG/VIAL INJECTABLE / INJECTION AP 2019-04-02 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A209278-001 CARMUSTINE 100MG/VIAL INJECTABLE / INJECTION AP 2019-04-02 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A209278-001 CARMUSTINE 100MG/VIAL INJECTABLE / INJECTION AP 2019-04-02 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A209278-001 CARMUSTINE 100MG/VIAL INJECTABLE / INJECTION AP 2019-04-02 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A209278-001 CARMUSTINE 100MG/VIAL INJECTABLE / INJECTION AP 2019-04-02 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A209278-001 CARMUSTINE 100MG/VIAL INJECTABLE / INJECTION AP 2019-04-02 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A209278-001 CARMUSTINE 100MG/VIAL INJECTABLE / INJECTION AP 2019-04-02 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A209278-001 CARMUSTINE 100MG/VIAL INJECTABLE / INJECTION AP 2019-04-02 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A209278-001 CARMUSTINE 100MG/VIAL INJECTABLE / INJECTION AP 2019-04-02 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A209278-001 CARMUSTINE 100MG/VIAL INJECTABLE / INJECTION AP 2019-04-02 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A209278-001 CARMUSTINE 100MG/VIAL INJECTABLE / INJECTION AP 2019-04-02 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A209278-001 CARMUSTINE 100MG/VIAL INJECTABLE / INJECTION AP 2019-04-02 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A209278-001 CARMUSTINE 100MG/VIAL INJECTABLE / INJECTION AP 2019-04-02 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A209278-001 CARMUSTINE 100MG/VIAL INJECTABLE / INJECTION AP 2019-04-02 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A209278-001 CARMUSTINE 100MG/VIAL INJECTABLE / INJECTION AP 2019-04-02 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A209278-001 CARMUSTINE 100MG/VIAL INJECTABLE / INJECTION AP 2019-04-02 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A209278-001 CARMUSTINE 100MG/VIAL INJECTABLE / INJECTION AP 2019-04-02 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A209278-001 CARMUSTINE 100MG/VIAL INJECTABLE / INJECTION AP 2019-04-02 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A209278-001 CARMUSTINE 100MG/VIAL INJECTABLE / INJECTION AP 2019-04-02 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A209278-001 CARMUSTINE 100MG/VIAL INJECTABLE / INJECTION AP 2019-04-02 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A209278-001 CARMUSTINE 100MG/VIAL INJECTABLE / INJECTION AP 2019-04-02 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A209278-001 CARMUSTINE 100MG/VIAL INJECTABLE / INJECTION AP 2019-04-02 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A209278-001 CARMUSTINE 100MG/VIAL INJECTABLE / INJECTION AP 2019-04-02 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A209278-001 CARMUSTINE 100MG/VIAL INJECTABLE / INJECTION AP 2019-04-02 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A209278-001 CARMUSTINE 100MG/VIAL INJECTABLE / INJECTION AP 2019-04-02 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
FDA-Initiated Inactive NDC Indexing# 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 Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Carmustine CARMUSTINE KVK-Tech, Inc. 11c3fad8-65ef-39a7-e063-6294a90a73e1 2025-11-14 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 209278 application number: ANDA209278
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 54879-036-64 54879003664 1 KIT in 1 CARTON (54879-036-64) * 30 mL in 1 VIAL, SINGLE-DOSE (54879-023-51) * 3 mL in 1 VIAL (54879-024-13) 1 kit 2019-05-16 0000-00-00 No No Current