Home NDC 46708-659 Carmustine
Product NDC 46708-659
11-digit product format 467080659
Labeler code 46708
Product ID 46708-659_6e0cfe79-6998-45b2-bceb-f8848624be5a
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Carmustine
Dosage form KIT
Labeler Alembic Pharmaceuticals Limited
Application ANDA215730
Marketing category ANDA
Marketing start 2023-10-20
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes 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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A215730-001 CARMUSTINE CARMUSTINE 100MG/VIAL INJECTABLE / INJECTION AP 2023-10-20
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A215730-001 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.
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 A215730-001 CARMUSTINE 100MG/VIAL INJECTABLE / INJECTION AP 2023-10-20 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A215730-001 CARMUSTINE 100MG/VIAL INJECTABLE / INJECTION AP 2023-10-20 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A215730-001 CARMUSTINE 100MG/VIAL INJECTABLE / INJECTION AP 2023-10-20 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A215730-001 CARMUSTINE 100MG/VIAL INJECTABLE / INJECTION AP 2023-10-20 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A215730-001 CARMUSTINE 100MG/VIAL INJECTABLE / INJECTION AP 2023-10-20 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A215730-001 CARMUSTINE 100MG/VIAL INJECTABLE / INJECTION AP 2023-10-20 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A215730-001 CARMUSTINE 100MG/VIAL INJECTABLE / INJECTION AP 2023-10-20 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A215730-001 CARMUSTINE 100MG/VIAL INJECTABLE / INJECTION AP 2023-10-20 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A215730-001 CARMUSTINE 100MG/VIAL INJECTABLE / INJECTION AP 2023-10-20 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A215730-001 CARMUSTINE 100MG/VIAL INJECTABLE / INJECTION AP 2023-10-20 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A215730-001 CARMUSTINE 100MG/VIAL INJECTABLE / INJECTION AP 2023-10-20 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A215730-001 CARMUSTINE 100MG/VIAL INJECTABLE / INJECTION AP 2023-10-20 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A215730-001 CARMUSTINE 100MG/VIAL INJECTABLE / INJECTION AP 2023-10-20 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A215730-001 CARMUSTINE 100MG/VIAL INJECTABLE / INJECTION AP 2023-10-20 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A215730-001 CARMUSTINE 100MG/VIAL INJECTABLE / INJECTION AP 2023-10-20 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A215730-001 CARMUSTINE 100MG/VIAL INJECTABLE / INJECTION AP 2023-10-20 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A215730-001 CARMUSTINE 100MG/VIAL INJECTABLE / INJECTION AP 2023-10-20 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A215730-001 CARMUSTINE 100MG/VIAL INJECTABLE / INJECTION AP 2023-10-20 a72a2bbeb626…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A215730-001 CARMUSTINE 100MG/VIAL INJECTABLE / INJECTION AP 2023-10-20 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Carmustine
Listing expiration 2026-12-31 Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 309012 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 46708-658-31 Carmustine 30 mL in 1 VIAL, SINGLE-DOSE INJECTION, POWDER, LYOPHILIZED, 30 mL 100 mg in 30mL 1 46708-659-02 Carmustine 1 in 1 CARTON KIT 1 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 46708-659 CARMUSTINE KIT [ALEMBIC PHARMACEUTICALS LIMITED] 1 Current NDC, 2 package rows 20231117_6e0cfe79-6998-45b2-bceb-f8848624be5a.zip
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 · 2 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 46708-658-31 46708065831 30 mL in 1 VIAL, SINGLE-DOSE 30 ml Historical 46708-659-02 46708065902 1 KIT in 1 CARTON (46708-659-02) * 30 mL in 1 VIAL, SINGLE-DOSE (46708-658-31) * 3 mL in 1 VIAL (46708-660-03) 1 kit 2023-10-20 No No Current