Home NDC 60505-6228 Bendamustine Hydrochloride
Product NDC 60505-6228
11-digit product format 605056228
Labeler code 60505
Product ID 60505-6228_5ebe4a1f-c7d6-95a3-8f21-8deebf9bd43a
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Bendamustine Hydrochloride
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler Apotex Corp
Application NDA215033
Marketing category NDA
Marketing start 2023-04-26
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 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 N215033-001 BENDAMUSTINE HYDROCHLORIDE BENDAMUSTINE HYDROCHLORIDE 100MG/4ML (25MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2022-12-07
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N215033-001 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 N215033-001 BENDAMUSTINE HYDROCHLORIDE 100MG/4ML (25MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2022-12-07 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215033-001 BENDAMUSTINE HYDROCHLORIDE 100MG/4ML (25MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2022-12-07 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N215033-001 BENDAMUSTINE HYDROCHLORIDE 100MG/4ML (25MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2022-12-07 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N215033-001 BENDAMUSTINE HYDROCHLORIDE 100MG/4ML (25MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2022-12-07 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N215033-001 BENDAMUSTINE HYDROCHLORIDE 100MG/4ML (25MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2022-12-07 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N215033-001 BENDAMUSTINE HYDROCHLORIDE 100MG/4ML (25MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2022-12-07 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N215033-001 BENDAMUSTINE HYDROCHLORIDE 100MG/4ML (25MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2022-12-07 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N215033-001 BENDAMUSTINE HYDROCHLORIDE 100MG/4ML (25MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2022-12-07 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N215033-001 BENDAMUSTINE HYDROCHLORIDE 100MG/4ML (25MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2022-12-07 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N215033-001 BENDAMUSTINE HYDROCHLORIDE 100MG/4ML (25MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2022-12-07 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N215033-001 BENDAMUSTINE HYDROCHLORIDE 100MG/4ML (25MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2022-12-07 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N215033-001 BENDAMUSTINE HYDROCHLORIDE 100MG/4ML (25MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2022-12-07 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N215033-001 BENDAMUSTINE HYDROCHLORIDE 100MG/4ML (25MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2022-12-07 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N215033-001 BENDAMUSTINE HYDROCHLORIDE 100MG/4ML (25MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2022-12-07 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N215033-001 BENDAMUSTINE HYDROCHLORIDE 100MG/4ML (25MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2022-12-07 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N215033-001 BENDAMUSTINE HYDROCHLORIDE 100MG/4ML (25MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2022-12-07 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N215033-001 BENDAMUSTINE HYDROCHLORIDE 100MG/4ML (25MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2022-12-07 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N215033-001 BENDAMUSTINE HYDROCHLORIDE 100MG/4ML (25MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2022-12-07 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N215033-001 BENDAMUSTINE HYDROCHLORIDE 100MG/4ML (25MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2022-12-07 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N215033-001 BENDAMUSTINE HYDROCHLORIDE 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 N215033-001 BENDAMUSTINE HYDROCHLORIDE 100MG/4ML (25MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2022-12-07 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N215033-001 BENDAMUSTINE HYDROCHLORIDE 100MG/4ML (25MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2022-12-07 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N215033-001 BENDAMUSTINE HYDROCHLORIDE 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 N215033-001 BENDAMUSTINE HYDROCHLORIDE 100MG/4ML (25MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2022-12-07 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Bendamustine Hydrochloride
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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1726097 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 60505-6228-0 Bendamustine Hydrochloride 1 in 1 CARTON INJECTION, SOLUTION 1 8 60505-6228-0 Bendamustine Hydrochloride 5 mL in 1 VIAL, MULTI-DOSE INJECTION, SOLUTION 5 8
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 60505-6228 BENDAMUSTINE HYDROCHLORIDE INJECTION, SOLUTION [APOTEX CORP] 7 Current NDC, 2 package rows 20240413_085dd54c-4212-d879-afef-ee52732a48c0.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 Marketing start Sample Exclude flag Status 60505-6228-0 60505622800 1 VIAL, MULTI-DOSE in 1 CARTON (60505-6228-0) / 5 mL in 1 VIAL, MULTI-DOSE 2023-04-26 No No Current