Home NDC 70710-1525 carmustine
Product NDC 70710-1525
11-digit product format 707101525
Labeler code 70710
Product ID 70710-1525_542e0b79-fdc4-47c6-974b-86d986720e6d
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name carmustine
Dosage form KIT
Labeler Zydus Pharmaceuticals USA Inc.
Application ANDA210179
Marketing category ANDA
Marketing start 2020-12-24
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 44 .
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 A210179-001 CARMUSTINE CARMUSTINE 100MG/VIAL INJECTABLE / INJECTION AP 2018-09-11
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A210179-001 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 · 44 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 2026-10-15 13:18:30 2026-09 A210179-001 CARMUSTINE 100MG/VIAL INJECTABLE / INJECTION AP 2018-09-11 c2088c7a36db…2026-09-14 22:38:34 2026-08 A210179-001 CARMUSTINE 100MG/VIAL INJECTABLE / INJECTION AP 2018-09-11 84e616aacf4f…2026-08-18 06:07:40 2026-07 A210179-001 CARMUSTINE 100MG/VIAL INJECTABLE / INJECTION AP 2018-09-11 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A210179-001 CARMUSTINE 100MG/VIAL INJECTABLE / INJECTION AP 2018-09-11 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A210179-001 CARMUSTINE 100MG/VIAL INJECTABLE / INJECTION AP 2018-09-11 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A210179-001 CARMUSTINE 100MG/VIAL INJECTABLE / INJECTION AP 2018-09-11 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A210179-001 CARMUSTINE 100MG/VIAL INJECTABLE / INJECTION AP 2018-09-11 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A210179-001 CARMUSTINE 100MG/VIAL INJECTABLE / INJECTION AP 2018-09-11 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A210179-001 CARMUSTINE 100MG/VIAL INJECTABLE / INJECTION AP 2018-09-11 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A210179-001 CARMUSTINE 100MG/VIAL INJECTABLE / INJECTION AP 2018-09-11 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A210179-001 CARMUSTINE 100MG/VIAL INJECTABLE / INJECTION AP 2018-09-11 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A210179-001 CARMUSTINE 100MG/VIAL INJECTABLE / INJECTION AP 2018-09-11 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A210179-001 CARMUSTINE 100MG/VIAL INJECTABLE / INJECTION AP 2018-09-11 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A210179-001 CARMUSTINE 100MG/VIAL INJECTABLE / INJECTION AP 2018-09-11 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A210179-001 CARMUSTINE 100MG/VIAL INJECTABLE / INJECTION AP 2018-09-11 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A210179-001 CARMUSTINE 100MG/VIAL INJECTABLE / INJECTION AP 2018-09-11 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A210179-001 CARMUSTINE 100MG/VIAL INJECTABLE / INJECTION AP 2018-09-11 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A210179-001 CARMUSTINE 100MG/VIAL INJECTABLE / INJECTION AP 2018-09-11 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A210179-001 CARMUSTINE 100MG/VIAL INJECTABLE / INJECTION AP 2018-09-11 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A210179-001 CARMUSTINE 100MG/VIAL INJECTABLE / INJECTION AP 2018-09-11 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A210179-001 CARMUSTINE 100MG/VIAL INJECTABLE / INJECTION AP 2018-09-11 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A210179-001 CARMUSTINE 100MG/VIAL INJECTABLE / INJECTION AP 2018-09-11 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A210179-001 CARMUSTINE 100MG/VIAL INJECTABLE / INJECTION AP 2018-09-11 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A210179-001 CARMUSTINE 100MG/VIAL INJECTABLE / INJECTION AP 2018-09-11 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A210179-001 CARMUSTINE 100MG/VIAL INJECTABLE / INJECTION AP 2018-09-11 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A210179-001 CARMUSTINE 100MG/VIAL INJECTABLE / INJECTION AP 2018-09-11 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A210179-001 CARMUSTINE 100MG/VIAL INJECTABLE / INJECTION AP 2018-09-11 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A210179-001 CARMUSTINE 100MG/VIAL INJECTABLE / INJECTION AP 2018-09-11 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A210179-001 CARMUSTINE 100MG/VIAL INJECTABLE / INJECTION AP 2018-09-11 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A210179-001 CARMUSTINE 100MG/VIAL INJECTABLE / INJECTION AP 2018-09-11 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A210179-001 CARMUSTINE 100MG/VIAL INJECTABLE / INJECTION AP 2018-09-11 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A210179-001 CARMUSTINE 100MG/VIAL INJECTABLE / INJECTION AP 2018-09-11 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A210179-001 CARMUSTINE 100MG/VIAL INJECTABLE / INJECTION AP 2018-09-11 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A210179-001 CARMUSTINE 100MG/VIAL INJECTABLE / INJECTION AP 2018-09-11 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A210179-001 CARMUSTINE 100MG/VIAL INJECTABLE / INJECTION AP 2018-09-11 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A210179-001 CARMUSTINE 100MG/VIAL INJECTABLE / INJECTION AP 2018-09-11 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A210179-001 CARMUSTINE 100MG/VIAL INJECTABLE / INJECTION AP 2018-09-11 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A210179-001 CARMUSTINE 100MG/VIAL INJECTABLE / INJECTION AP 2018-09-11 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A210179-001 CARMUSTINE 100MG/VIAL INJECTABLE / INJECTION AP 2018-09-11 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A210179-001 CARMUSTINE 100MG/VIAL INJECTABLE / INJECTION AP 2018-09-11 3a93d1ddd44b…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 44 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base carmustine
Listing expiration 2027-12-31 DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# NDC, Effective, Action table NDC Effective Action Document Indexing SPL Related label 70710-1525-9 2020-07-22 C162847 48780-1 ab0e2407-3151-f274-e053-dbdaa90a6471 These highlights do not include all the information needed to use carmustine for injection, USP safely and effectively. See full prescribing information for carmustine for injection, USP. Carmustine for injection, USP, for intravenous use Initial U.S. Approval: 1977 70710-1525-9 2020-07-22 C162847 48780-1 ab0e2407-3151-f274-e053-dbdaa90a6471 These highlights do not include all the information needed to use carmustine for injection, USP safely and effectively. See full prescribing information for carmustine for injection, USP. Carmustine for injection, USP, for intravenous use Initial U.S. Approval: 1977
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 70710-1524-1 carmustine 30 mL in 1 VIAL, SINGLE-DOSE FOR SOLUTION 30 mL 100 mg in 30mL 9 70710-1525-9 carmustine 1 in 1 CARTON KIT 1 9
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70710-1525 CARMUSTINE (CARMUSTINE ) KIT [ZYDUS PHARMACEUTICALS USA INC.] 8 Current NDC, Legacy NDC, 2 package rows 20241218_0bdd91e1-fd94-4ce8-9c99-1b0fa6fe8ae4.zip
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 70710-1524-1 70710152401 30 mL in 1 VIAL, SINGLE-DOSE 30 ml Historical 70710-1525-9 70710152509 1 KIT in 1 CARTON (70710-1525-9) * 3 mL in 1 VIAL (70710-1523-1) * 30 mL in 1 VIAL, SINGLE-DOSE (70710-1524-1) 1 kit 2020-12-24 0000-00-00 No No Current