Home NDC 16729-548-63 CARMUSTINE
Product NDC 16729-548
Requested package NDC 16729-548-63
11-digit product format 167290548
Labeler code 16729
Product ID 16729-548_e6d82717-984f-2b85-e053-2a95a90ac34f
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name CARMUSTINE
Dosage form KIT
Labeler Accord Healthcare Inc.
Application NDA215000
Marketing category NDA
Marketing start 2022-08-18
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 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N215000-001 CARMUSTINE CARMUSTINE 50MG/VIAL POWDER / INTRAVENOUS RLD 2022-05-16 N215000-002 CARMUSTINE CARMUSTINE 300MG/VIAL POWDER / INTRAVENOUS RLD 2022-05-16
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 · 58 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 2026-02-19 14:30 UTC 2026-02 N215000-001 CARMUSTINE 50MG/VIAL POWDER / INTRAVENOUS RLD 2022-05-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215000-002 CARMUSTINE 300MG/VIAL POWDER / INTRAVENOUS RLD 2022-05-16 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215000-001 CARMUSTINE 50MG/VIAL POWDER / INTRAVENOUS RLD 2022-05-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215000-002 CARMUSTINE 300MG/VIAL POWDER / INTRAVENOUS RLD 2022-05-16 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N215000-001 CARMUSTINE 50MG/VIAL POWDER / INTRAVENOUS RLD 2022-05-16 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N215000-002 CARMUSTINE 300MG/VIAL POWDER / INTRAVENOUS RLD 2022-05-16 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N215000-001 CARMUSTINE 50MG/VIAL POWDER / INTRAVENOUS RLD 2022-05-16 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N215000-002 CARMUSTINE 300MG/VIAL POWDER / INTRAVENOUS RLD 2022-05-16 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N215000-001 CARMUSTINE 50MG/VIAL POWDER / INTRAVENOUS RLD 2022-05-16 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N215000-002 CARMUSTINE 300MG/VIAL POWDER / INTRAVENOUS RLD 2022-05-16 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N215000-001 CARMUSTINE 50MG/VIAL POWDER / INTRAVENOUS RLD 2022-05-16 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N215000-002 CARMUSTINE 300MG/VIAL POWDER / INTRAVENOUS RLD 2022-05-16 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N215000-001 CARMUSTINE 50MG/VIAL POWDER / INTRAVENOUS RLD 2022-05-16 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N215000-002 CARMUSTINE 300MG/VIAL POWDER / INTRAVENOUS RLD 2022-05-16 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N215000-001 CARMUSTINE 50MG/VIAL POWDER / INTRAVENOUS RLD 2022-05-16 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N215000-002 CARMUSTINE 300MG/VIAL POWDER / INTRAVENOUS RLD 2022-05-16 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N215000-001 CARMUSTINE 50MG/VIAL POWDER / INTRAVENOUS RLD 2022-05-16 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N215000-002 CARMUSTINE 300MG/VIAL POWDER / INTRAVENOUS RLD 2022-05-16 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N215000-001 CARMUSTINE 50MG/VIAL POWDER / INTRAVENOUS RLD 2022-05-16 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N215000-002 CARMUSTINE 300MG/VIAL POWDER / INTRAVENOUS RLD 2022-05-16 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N215000-001 CARMUSTINE 50MG/VIAL POWDER / INTRAVENOUS RLD 2022-05-16 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N215000-002 CARMUSTINE 300MG/VIAL POWDER / INTRAVENOUS RLD 2022-05-16 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N215000-001 CARMUSTINE 50MG/VIAL POWDER / INTRAVENOUS RLD 2022-05-16 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N215000-002 CARMUSTINE 300MG/VIAL POWDER / INTRAVENOUS RLD 2022-05-16 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N215000-001 CARMUSTINE 50MG/VIAL POWDER / INTRAVENOUS RLD 2022-05-16 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N215000-002 CARMUSTINE 300MG/VIAL POWDER / INTRAVENOUS RLD 2022-05-16 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N215000-001 CARMUSTINE 50MG/VIAL POWDER / INTRAVENOUS RLD, RS 2022-05-16 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N215000-002 CARMUSTINE 300MG/VIAL POWDER / INTRAVENOUS RLD, RS 2022-05-16 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N215000-001 CARMUSTINE 50MG/VIAL POWDER / INTRAVENOUS RLD, RS 2022-05-16 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N215000-002 CARMUSTINE 300MG/VIAL POWDER / INTRAVENOUS RLD, RS 2022-05-16 5c6f7cd8ea54…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N215000-001 CARMUSTINE 50MG/VIAL POWDER / INTRAVENOUS RLD, RS 2022-05-16 6a51e52b5d6a…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N215000-002 CARMUSTINE 300MG/VIAL POWDER / INTRAVENOUS RLD, RS 2022-05-16 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N215000-001 CARMUSTINE 50MG/VIAL POWDER / INTRAVENOUS RLD, RS 2022-05-16 1c564ffb4f44…2024-02-18 07:12 UTC 2024-02 N215000-002 CARMUSTINE 300MG/VIAL POWDER / INTRAVENOUS RLD, RS 2022-05-16 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N215000-001 CARMUSTINE 50MG/VIAL POWDER / INTRAVENOUS RLD, RS 2022-05-16 ea1830bbd6c7…2023-12-20 04:57 UTC 2023-12 N215000-002 CARMUSTINE 300MG/VIAL POWDER / INTRAVENOUS RLD, RS 2022-05-16 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N215000-001 CARMUSTINE 50MG/VIAL POWDER / INTRAVENOUS RLD, RS 2022-05-16 a72a2bbeb626…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N215000-002 CARMUSTINE 300MG/VIAL POWDER / INTRAVENOUS RLD, RS 2022-05-16 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N215000-001 CARMUSTINE 50MG/VIAL POWDER / INTRAVENOUS RLD, RS 2022-05-16 9b2671bbb829…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N215000-002 CARMUSTINE 300MG/VIAL POWDER / INTRAVENOUS RLD, RS 2022-05-16 9b2671bbb829…
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 16729-548-63 16729054863 1 KIT in 1 CARTON (16729-548-63) * 9 mL in 1 VIAL (16729-547-19) * 100 mL in 1 VIAL, SINGLE-DOSE (16729-546-01) 1 kit 2022-08-18 0000-00-00 No No Current