Home NDC 71225-120 VIVIMUSTA
Product NDC 71225-120
11-digit product format 712250120
Labeler code 71225
Product ID 71225-120_c4b54079-dac2-4e01-a00f-6ceaa788f605
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name BENDAMUSTINE HYDROCHLORIDE
Dosage form INJECTION
Route INTRAVENOUS
Labeler Slayback Pharma LLC
Application NDA212209
Marketing category NDA
Marketing start 2022-12-07
Substance BENDAMUSTINE HYDROCHLORIDE
Active strength 25 mg/mL
Pharmacologic classes Alkylating Activity [MoA], Alkylating Drug [EPC]
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 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 N212209-001 VIVIMUSTA BENDAMUSTINE HYDROCHLORIDE 100MG/4ML (25MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2022-12-07
Orange Book patents# Current patent rows page 1 of 1 · 4 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N212209-001 11707450 2042-07-29 Drug product 2025-11-17 N212209-001 11844784 2042-07-29 Drug product 2023-12-19 N212209-001 12208086 2042-07-29 Drug product 2025-02-07 N212209-001 12419867 2042-07-29 Drug product 2025-11-17
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 2026-08-18 06:07:40 2026-07 N212209-001 VIVIMUSTA 100MG/4ML (25MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2022-12-07 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N212209-001 VIVIMUSTA 100MG/4ML (25MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2022-12-07 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N212209-001 VIVIMUSTA 100MG/4ML (25MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2022-12-07 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N212209-001 VIVIMUSTA 100MG/4ML (25MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2022-12-07 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N212209-001 VIVIMUSTA 100MG/4ML (25MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2022-12-07 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N212209-001 VIVIMUSTA 100MG/4ML (25MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2022-12-07 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N212209-001 VIVIMUSTA 100MG/4ML (25MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2022-12-07 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N212209-001 VIVIMUSTA 100MG/4ML (25MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2022-12-07 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N212209-001 VIVIMUSTA 100MG/4ML (25MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2022-12-07 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N212209-001 VIVIMUSTA 100MG/4ML (25MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2022-12-07 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N212209-001 VIVIMUSTA 100MG/4ML (25MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2022-12-07 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N212209-001 VIVIMUSTA 100MG/4ML (25MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2022-12-07 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N212209-001 VIVIMUSTA 100MG/4ML (25MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2022-12-07 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N212209-001 VIVIMUSTA 100MG/4ML (25MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2022-12-07 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N212209-001 VIVIMUSTA 100MG/4ML (25MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2022-12-07 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N212209-001 VIVIMUSTA 100MG/4ML (25MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2022-12-07 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N212209-001 VIVIMUSTA 100MG/4ML (25MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2022-12-07 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N212209-001 VIVIMUSTA 100MG/4ML (25MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2022-12-07 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N212209-001 VIVIMUSTA 100MG/4ML (25MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2022-12-07 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N212209-001 VIVIMUSTA 100MG/4ML (25MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2022-12-07 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N212209-001 VIVIMUSTA 100MG/4ML (25MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2022-12-07 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N212209-001 VIVIMUSTA 100MG/4ML (25MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2022-12-07 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N212209-001 VIVIMUSTA 100MG/4ML (25MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2022-12-07 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N212209-001 VIVIMUSTA 100MG/4ML (25MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2022-12-07 3bdfa0b2c4d7…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N212209-001 VIVIMUSTA 100MG/4ML (25MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2022-12-07 a50c72e98297…
Observed Orange Book patent history# Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-08-18 06:07:40 2026-07 N212209-001 11707450 2042-07-29 Drug product 2025-11-17 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N212209-001 11844784 2042-07-29 Drug product 2023-12-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N212209-001 12208086 2042-07-29 Drug product 2025-02-07 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N212209-001 12419867 2042-07-29 Drug product 2025-11-17 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N212209-001 11707450 2042-07-29 Drug product 2025-11-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212209-001 11844784 2042-07-29 Drug product 2023-12-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212209-001 12208086 2042-07-29 Drug product 2025-02-07 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212209-001 12419867 2042-07-29 Drug product 2025-11-17 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N212209-001 11707450 2042-07-29 Drug product 2025-11-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N212209-001 11844784 2042-07-29 Drug product 2023-12-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N212209-001 12208086 2042-07-29 Drug product 2025-02-07 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N212209-001 12419867 2042-07-29 Drug product 2025-11-17 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N212209-001 11844784 2042-07-29 Drug product 2023-12-19 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N212209-001 12208086 2042-07-29 Drug product 2025-02-07 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N212209-001 11844784 2042-07-29 Drug product 2023-12-19 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N212209-001 12208086 2042-07-29 Drug product 2025-02-07 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N212209-001 11844784 2042-07-29 Drug product 2023-12-19 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N212209-001 12208086 2042-07-29 Drug product 2025-02-07 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N212209-001 11844784 2042-07-29 Drug product 2023-12-19 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N212209-001 11844784 2042-07-29 Drug product 2023-12-19 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N212209-001 11844784 2042-07-29 Drug product 2023-12-19 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N212209-001 11844784 2042-07-29 Drug product 2023-12-19 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N212209-001 11844784 2042-07-29 Drug product 2023-12-19 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N212209-001 11844784 2042-07-29 Drug product 2023-12-19 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N212209-001 11844784 2042-07-29 Drug product 2023-12-19 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N212209-001 11844784 2042-07-29 Drug product 2023-12-19 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N212209-001 11844784 2042-07-29 Drug product 2023-12-19 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N212209-001 11844784 2042-07-29 Drug product 2023-12-19 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N212209-001 11844784 2042-07-29 Drug product 2023-12-19 1c564ffb4f44…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N212209-001 11707450 2042-07-29 Drug product 2025-11-17 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N212209-001 11844784 2042-07-29 Drug product 2023-12-19 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N212209-001 12208086 2042-07-29 Drug product 2025-02-07 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N212209-001 12419867 2042-07-29 Drug product 2025-11-17 a50c72e98297…
Additional Listing Data#
Finished product Yes
Brand name base VIVIMUSTA
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength BENDAMUSTINE HYDROCHLORIDE 25 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 981Y8SX18M Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1726097 Internal RxNorm lookup 2622914 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 71225-120-01 VIVIMUSTA 1 in 1 CARTON INJECTION 1 22 71225-120-01 VIVIMUSTA 4 mL in 1 VIAL, MULTI-DOSE INJECTION 4 22
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 71225-120 VIVIMUSTA (BENDAMUSTINE HYDROCHLORIDE) INJECTION [SLAYBACK PHARMA LLC] 22 Current NDC, Legacy NDC, 2 package rows 20240925_cbcc6eb7-aa62-4599-af49-05203fedb4bb.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 Marketing start Marketing end Sample Exclude flag Status 71225-120-01 71225012001 1 VIAL, MULTI-DOSE in 1 CARTON (71225-120-01) / 4 mL in 1 VIAL, MULTI-DOSE 2022-12-07 0000-00-00 No No Current