Home NDC 72205-198 Carmustine
Product NDC 72205-198
11-digit product format 722050198
Labeler code 72205
Product ID 72205-198_e6e28c8c-f793-41f3-aaeb-7bf412660288
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Carmustine
Dosage form KIT
Labeler Novadoz Pharmaceuticals LLC
Application ANDA214814
Marketing category ANDA
Marketing start 2023-05-11
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 A214814-001 CARMUSTINE CARMUSTINE 100MG/VIAL INJECTABLE / INJECTION AP 2023-05-11
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A214814-001 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 A214814-001 CARMUSTINE 100MG/VIAL INJECTABLE / INJECTION AP 2023-05-11 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A214814-001 CARMUSTINE 100MG/VIAL INJECTABLE / INJECTION AP 2023-05-11 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A214814-001 CARMUSTINE 100MG/VIAL INJECTABLE / INJECTION AP 2023-05-11 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A214814-001 CARMUSTINE 100MG/VIAL INJECTABLE / INJECTION AP 2023-05-11 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A214814-001 CARMUSTINE 100MG/VIAL INJECTABLE / INJECTION AP 2023-05-11 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A214814-001 CARMUSTINE 100MG/VIAL INJECTABLE / INJECTION AP 2023-05-11 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A214814-001 CARMUSTINE 100MG/VIAL INJECTABLE / INJECTION AP 2023-05-11 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A214814-001 CARMUSTINE 100MG/VIAL INJECTABLE / INJECTION AP 2023-05-11 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A214814-001 CARMUSTINE 100MG/VIAL INJECTABLE / INJECTION AP 2023-05-11 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A214814-001 CARMUSTINE 100MG/VIAL INJECTABLE / INJECTION AP 2023-05-11 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A214814-001 CARMUSTINE 100MG/VIAL INJECTABLE / INJECTION AP 2023-05-11 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A214814-001 CARMUSTINE 100MG/VIAL INJECTABLE / INJECTION AP 2023-05-11 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A214814-001 CARMUSTINE 100MG/VIAL INJECTABLE / INJECTION AP 2023-05-11 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A214814-001 CARMUSTINE 100MG/VIAL INJECTABLE / INJECTION AP 2023-05-11 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A214814-001 CARMUSTINE 100MG/VIAL INJECTABLE / INJECTION AP 2023-05-11 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A214814-001 CARMUSTINE 100MG/VIAL INJECTABLE / INJECTION AP 2023-05-11 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A214814-001 CARMUSTINE 100MG/VIAL INJECTABLE / INJECTION AP 2023-05-11 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A214814-001 CARMUSTINE 100MG/VIAL INJECTABLE / INJECTION AP 2023-05-11 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A214814-001 CARMUSTINE 100MG/VIAL INJECTABLE / INJECTION AP 2023-05-11 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A214814-001 CARMUSTINE 100MG/VIAL INJECTABLE / INJECTION AP 2023-05-11 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A214814-001 CARMUSTINE 100MG/VIAL INJECTABLE / INJECTION AP 2023-05-11 3f0d92c62455…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A214814-001 CARMUSTINE 100MG/VIAL INJECTABLE / INJECTION AP 2023-05-11 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 72205-197-01 Carmustine 30 mL in 1 VIAL, SINGLE-DOSE INJECTION, POWDER, LYOPHILIZED, 30 mL 100 mg in 30mL 1 72205-198-01 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 72205-198 CARMUSTINE KIT [NOVADOZ PHARMACEUTICALS LLC] 1 Current NDC, 2 package rows 20231123_e6e28c8c-f793-41f3-aaeb-7bf412660288.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 · 1 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 72205-197-01 72205019701 30 mL in 1 VIAL, SINGLE-DOSE 30 ml Historical 72205-198-01 72205019801 1 KIT in 1 CARTON (72205-198-01) * 3 mL in 1 VIAL (72205-196-01) * 30 mL in 1 VIAL, SINGLE-DOSE (72205-197-01) 1 kit 2023-11-23 No No Current