Home NDC 16729-250 bendamustine hydrochloride
Product NDC 16729-250
11-digit product format 167290250
Labeler code 16729
Product ID 16729-250_1d8759d2-4d4d-78ee-e063-6294a90a53ae
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name bendamustine hydrochloride
Dosage form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route INTRAVENOUS
Labeler Accord Healthcare, Inc.
Application ANDA205574
Marketing category ANDA
Marketing start 2022-12-07
Substance BENDAMUSTINE HYDROCHLORIDE
Active strength 25 mg/5mL
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 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A205574-001 BENDAMUSTINE HYDROCHLORIDE BENDAMUSTINE HYDROCHLORIDE 25MG/VIAL POWDER / INTRAVENOUS AP 2022-12-07 A205574-002 BENDAMUSTINE HYDROCHLORIDE BENDAMUSTINE HYDROCHLORIDE 100MG/VIAL POWDER / INTRAVENOUS AP 2022-12-07
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
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 · 50 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 2026-08-18 06:07:40 2026-07 A205574-001 BENDAMUSTINE HYDROCHLORIDE 25MG/VIAL POWDER / INTRAVENOUS AP 2022-12-07 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A205574-002 BENDAMUSTINE HYDROCHLORIDE 100MG/VIAL POWDER / INTRAVENOUS AP 2022-12-07 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A205574-001 BENDAMUSTINE HYDROCHLORIDE 25MG/VIAL POWDER / INTRAVENOUS AP 2022-12-07 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A205574-002 BENDAMUSTINE HYDROCHLORIDE 100MG/VIAL POWDER / INTRAVENOUS AP 2022-12-07 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A205574-001 BENDAMUSTINE HYDROCHLORIDE 25MG/VIAL POWDER / INTRAVENOUS AP 2022-12-07 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A205574-002 BENDAMUSTINE HYDROCHLORIDE 100MG/VIAL POWDER / INTRAVENOUS AP 2022-12-07 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A205574-001 BENDAMUSTINE HYDROCHLORIDE 25MG/VIAL POWDER / INTRAVENOUS AP 2022-12-07 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A205574-002 BENDAMUSTINE HYDROCHLORIDE 100MG/VIAL POWDER / INTRAVENOUS AP 2022-12-07 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A205574-001 BENDAMUSTINE HYDROCHLORIDE 25MG/VIAL POWDER / INTRAVENOUS AP 2022-12-07 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A205574-002 BENDAMUSTINE HYDROCHLORIDE 100MG/VIAL POWDER / INTRAVENOUS AP 2022-12-07 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A205574-001 BENDAMUSTINE HYDROCHLORIDE 25MG/VIAL POWDER / INTRAVENOUS AP 2022-12-07 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A205574-002 BENDAMUSTINE HYDROCHLORIDE 100MG/VIAL POWDER / INTRAVENOUS AP 2022-12-07 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A205574-001 BENDAMUSTINE HYDROCHLORIDE 25MG/VIAL POWDER / INTRAVENOUS AP 2022-12-07 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A205574-002 BENDAMUSTINE HYDROCHLORIDE 100MG/VIAL POWDER / INTRAVENOUS AP 2022-12-07 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A205574-001 BENDAMUSTINE HYDROCHLORIDE 25MG/VIAL POWDER / INTRAVENOUS AP 2022-12-07 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A205574-002 BENDAMUSTINE HYDROCHLORIDE 100MG/VIAL POWDER / INTRAVENOUS AP 2022-12-07 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A205574-001 BENDAMUSTINE HYDROCHLORIDE 25MG/VIAL POWDER / IV (INFUSION) AP 2022-12-07 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A205574-002 BENDAMUSTINE HYDROCHLORIDE 100MG/VIAL POWDER / IV (INFUSION) AP 2022-12-07 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A205574-001 BENDAMUSTINE HYDROCHLORIDE 25MG/VIAL POWDER / INTRAVENOUS AP 2022-12-07 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A205574-002 BENDAMUSTINE HYDROCHLORIDE 100MG/VIAL POWDER / INTRAVENOUS AP 2022-12-07 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A205574-001 BENDAMUSTINE HYDROCHLORIDE 25MG/VIAL POWDER / IV (INFUSION) AP 2022-12-07 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A205574-002 BENDAMUSTINE HYDROCHLORIDE 100MG/VIAL POWDER / IV (INFUSION) AP 2022-12-07 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A205574-001 BENDAMUSTINE HYDROCHLORIDE 25MG/VIAL POWDER / IV (INFUSION) AP 2022-12-07 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A205574-002 BENDAMUSTINE HYDROCHLORIDE 100MG/VIAL POWDER / IV (INFUSION) AP 2022-12-07 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A205574-001 BENDAMUSTINE HYDROCHLORIDE 25MG/VIAL POWDER / IV (INFUSION) AP 2022-12-07 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A205574-002 BENDAMUSTINE HYDROCHLORIDE 100MG/VIAL POWDER / IV (INFUSION) AP 2022-12-07 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A205574-001 BENDAMUSTINE HYDROCHLORIDE 25MG/VIAL POWDER / IV (INFUSION) AP 2022-12-07 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A205574-002 BENDAMUSTINE HYDROCHLORIDE 100MG/VIAL POWDER / IV (INFUSION) AP 2022-12-07 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A205574-001 BENDAMUSTINE HYDROCHLORIDE 25MG/VIAL POWDER / IV (INFUSION) AP 2022-12-07 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A205574-002 BENDAMUSTINE HYDROCHLORIDE 100MG/VIAL POWDER / IV (INFUSION) AP 2022-12-07 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A205574-001 BENDAMUSTINE HYDROCHLORIDE 25MG/VIAL POWDER / IV (INFUSION) AP 2022-12-07 6a51e52b5d6a…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A205574-002 BENDAMUSTINE HYDROCHLORIDE 100MG/VIAL POWDER / IV (INFUSION) AP 2022-12-07 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A205574-001 BENDAMUSTINE HYDROCHLORIDE 25MG/VIAL POWDER / IV (INFUSION) AP 2022-12-07 1c564ffb4f44…2024-02-18 07:12 UTC 2024-02 A205574-002 BENDAMUSTINE HYDROCHLORIDE 100MG/VIAL POWDER / IV (INFUSION) AP 2022-12-07 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A205574-001 BENDAMUSTINE HYDROCHLORIDE 25MG/VIAL POWDER / IV (INFUSION) AP 2022-12-07 ea1830bbd6c7…2023-12-20 04:57 UTC 2023-12 A205574-002 BENDAMUSTINE HYDROCHLORIDE 100MG/VIAL POWDER / IV (INFUSION) AP 2022-12-07 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A205574-001 BENDAMUSTINE HYDROCHLORIDE 25MG/VIAL POWDER / IV (INFUSION) AP 2022-12-07 a72a2bbeb626…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A205574-002 BENDAMUSTINE HYDROCHLORIDE 100MG/VIAL POWDER / IV (INFUSION) AP 2022-12-07 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A205574-001 BENDAMUSTINE HYDROCHLORIDE 25MG/VIAL POWDER / IV (INFUSION) AP 2022-12-07 9b2671bbb829…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A205574-002 BENDAMUSTINE HYDROCHLORIDE 100MG/VIAL POWDER / IV (INFUSION) AP 2022-12-07 9b2671bbb829…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 50 observed states.
Observed Orange Book exclusivity 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/5mL
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 1805001 Internal RxNorm lookup 1805007 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 16729-250-03 bendamustine hydrochloride 5 mL in 1 VIAL, SINGLE-DOSE INJECTION, POWDER, LYOPHILIZED, 5 6 16729-250-03 bendamustine hydrochloride 1 in 1 CARTON INJECTION, POWDER, LYOPHILIZED, 1 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 16729-250 BENDAMUSTINE HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [ACCORD HEALTHCARE, INC.] 6 Current NDC, Legacy NDC, 2 package rows 20240719_33867f0f-f317-1fd0-e054-00144ff8d46c.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 16729-250-03 16729025003 1 VIAL, SINGLE-DOSE in 1 CARTON (16729-250-03) / 5 mL in 1 VIAL, SINGLE-DOSE 2022-12-07 0000-00-00 No No Current