Home NDC 63459-348 Bendeka
Product NDC 63459-348
11-digit product format 634590348
Labeler code 63459
Product ID 63459-348_bcfd315e-9ade-4659-9f1c-dfb687ba39de
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name bendamustine hydrochloride
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler Teva Pharmaceuticals USA, Inc.
Application NDA208194
Marketing category NDA
Marketing start 2015-12-08
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 N208194-001 BENDEKA BENDAMUSTINE HYDROCHLORIDE 100MG/4ML (25MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2015-12-07
Orange Book patents# Current patent rows page 1 of 1 · 32 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 · 41 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 2026-02-19 14:30 UTC 2026-02 N208194-001 BENDEKA 100MG/4ML (25MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2015-12-07 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208194-001 BENDEKA 100MG/4ML (25MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2015-12-07 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N208194-001 BENDEKA 100MG/4ML (25MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2015-12-07 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N208194-001 BENDEKA 100MG/4ML (25MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2015-12-07 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N208194-001 BENDEKA 100MG/4ML (25MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2015-12-07 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N208194-001 BENDEKA 100MG/4ML (25MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2015-12-07 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N208194-001 BENDEKA 100MG/4ML (25MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2015-12-07 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N208194-001 BENDEKA 100MG/4ML (25MG/ML) SOLUTION / IV (INFUSION) RLD, RS 2015-12-07 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N208194-001 BENDEKA 100MG/4ML (25MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2015-12-07 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N208194-001 BENDEKA 100MG/4ML (25MG/ML) SOLUTION / IV (INFUSION) RLD, RS 2015-12-07 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N208194-001 BENDEKA 100MG/4ML (25MG/ML) SOLUTION / IV (INFUSION) RLD, RS 2015-12-07 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N208194-001 BENDEKA 100MG/4ML (25MG/ML) SOLUTION / IV (INFUSION) RLD, RS 2015-12-07 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N208194-001 BENDEKA 100MG/4ML (25MG/ML) SOLUTION / IV (INFUSION) RLD, RS 2015-12-07 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N208194-001 BENDEKA 100MG/4ML (25MG/ML) SOLUTION / IV (INFUSION) RLD, RS 2015-12-07 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N208194-001 BENDEKA 100MG/4ML (25MG/ML) SOLUTION / IV (INFUSION) RLD, RS 2015-12-07 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N208194-001 BENDEKA 100MG/4ML (25MG/ML) SOLUTION / IV (INFUSION) RLD, RS 2015-12-07 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N208194-001 BENDEKA 100MG/4ML (25MG/ML) SOLUTION / IV (INFUSION) RLD, RS 2015-12-07 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N208194-001 BENDEKA 100MG/4ML (25MG/ML) SOLUTION / IV (INFUSION) RLD, RS 2015-12-07 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N208194-001 BENDEKA 100MG/4ML (25MG/ML) SOLUTION / IV (INFUSION) RLD, RS 2015-12-07 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N208194-001 BENDEKA 100MG/4ML (25MG/ML) SOLUTION / IV (INFUSION) RLD, RS 2015-12-07 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N208194-001 BENDEKA 100MG/4ML (25MG/ML) SOLUTION / IV (INFUSION) RLD, RS 2015-12-07 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N208194-001 BENDEKA 100MG/4ML (25MG/ML) SOLUTION / IV (INFUSION) RLD, RS 2015-12-07 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N208194-001 BENDEKA 100MG/4ML (25MG/ML) SOLUTION / IV (INFUSION) RLD, RS 2015-12-07 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N208194-001 BENDEKA 100MG/4ML (25MG/ML) SOLUTION / IV (INFUSION) RLD, RS 2015-12-07 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N208194-001 BENDEKA 100MG/4ML (25MG/ML) SOLUTION / IV (INFUSION) RLD, RS 2015-12-07 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N208194-001 BENDEKA 100MG/4ML (25MG/ML) SOLUTION / IV (INFUSION) RLD, RS 2015-12-07 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N208194-001 BENDEKA 100MG/4ML (25MG/ML) SOLUTION / IV (INFUSION) RLD, RS 2015-12-07 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N208194-001 BENDEKA 100MG/4ML (25MG/ML) SOLUTION / IV (INFUSION) RLD, RS 2015-12-07 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N208194-001 BENDEKA 100MG/4ML (25MG/ML) SOLUTION / IV (INFUSION) RLD, RS 2015-12-07 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N208194-001 BENDEKA 100MG/4ML (25MG/ML) SOLUTION / IV (INFUSION) RLD, RS 2015-12-07 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N208194-001 BENDEKA 100MG/4ML (25MG/ML) SOLUTION / IV (INFUSION) RLD, RS 2015-12-07 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N208194-001 BENDEKA 100MG/4ML (25MG/ML) SOLUTION / IV (INFUSION) RLD, RS 2015-12-07 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N208194-001 BENDEKA 100MG/4ML (25MG/ML) SOLUTION / IV (INFUSION) RLD, RS 2015-12-07 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N208194-001 BENDEKA 100MG/4ML (25MG/ML) SOLUTION / IV (INFUSION) RLD, RS 2015-12-07 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N208194-001 BENDEKA 100MG/4ML (25MG/ML) SOLUTION / IV (INFUSION) RLD, RS 2015-12-07 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N208194-001 BENDEKA 100MG/4ML (25MG/ML) SOLUTION / IV (INFUSION) RLD, RS 2015-12-07 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N208194-001 BENDEKA 100MG/4ML (25MG/ML) SOLUTION / IV (INFUSION) RLD, RS 2015-12-07 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N208194-001 BENDEKA 100MG/4ML (25MG/ML) SOLUTION / IV (INFUSION) RLD, RS 2015-12-07 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N208194-001 BENDEKA 100MG/4ML (25MG/ML) SOLUTION / IV (INFUSION) RLD, RS 2015-12-07 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N208194-001 BENDEKA 100MG/4ML (25MG/ML) SOLUTION / IV (INFUSION) RLD, RS 2015-12-07 cb3db0bc1861…
Observed Orange Book patent history# Patent history page 1 of 27 · 1,054 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N208194-001 8791270 2026-01-12 U-1790 Drug product 2016-01-07 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208194-001 10010533 2031-01-28 Drug product 2018-07-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208194-001 11103483 2031-01-28 U-1971 Drug product 2021-08-31 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208194-001 11103483 2031-01-28 U-1972 Drug product 2021-08-31 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208194-001 11844783 2031-01-28 U-1542 2023-12-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208194-001 11844783 2031-01-28 U-1972 2023-12-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208194-001 11844783 2031-01-28 U-1971 2023-12-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208194-001 11872214 2031-01-28 Drug product 2024-01-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208194-001 12138248 2031-01-28 Drug product 2025-01-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208194-001 12350257 2031-01-28 U-1542 Drug product 2025-07-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208194-001 12350257 2031-01-28 U-1971 Drug product 2025-07-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208194-001 12350257 2031-01-28 U-1972 Drug product 2025-07-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208194-001 9265831 2031-01-28 Drug product 2016-03-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208194-001 9572796 2031-01-28 U-1972 Drug product 2017-02-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208194-001 9572796 2031-01-28 U-1971 Drug product 2017-02-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208194-001 9572797 2031-01-28 U-1971 2017-02-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208194-001 9572797 2031-01-28 U-1972 2017-02-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208194-001 8609707 2031-08-11 U-1542 Drug product 2015-12-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208194-001 10052385 2033-03-15 U-1972 2018-08-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208194-001 10052385 2033-03-15 U-1971 2018-08-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208194-001 9000021 2033-03-15 U-1542 2015-12-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208194-001 9034908 2033-03-15 U-1542 2015-12-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208194-001 9144568 2033-03-15 U-1542 2015-12-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208194-001 9572887 2033-03-15 U-1972 2017-02-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208194-001 9572887 2033-03-15 U-1971 2017-02-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208194-001 9579384 2033-03-15 U-1971 2017-02-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208194-001 9579384 2033-03-15 U-1972 2017-02-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208194-001 9597397 2033-03-15 U-1972 2017-03-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208194-001 9597397 2033-03-15 U-1971 2017-03-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208194-001 9597398 2033-03-15 U-1971 2017-03-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208194-001 9597399 2033-03-15 U-1972 2017-03-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208194-001 9597399 2033-03-15 U-1971 2017-03-21 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208194-001 8791270 2026-01-12 U-1790 Drug product 2016-01-07 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208194-001 10010533 2031-01-28 Drug product 2018-07-03 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208194-001 11103483 2031-01-28 U-1971 Drug product 2021-08-31 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208194-001 11103483 2031-01-28 U-1972 Drug product 2021-08-31 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208194-001 11844783 2031-01-28 U-1542 2023-12-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208194-001 11844783 2031-01-28 U-1972 2023-12-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208194-001 11844783 2031-01-28 U-1971 2023-12-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208194-001 11872214 2031-01-28 Drug product 2024-01-16 31067a03dcf5…
Observed Orange Book exclusivity history# Additional Listing Data#
Finished product Yes
Brand name base Bendeka
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 1726102 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 63459-348-04 Bendeka 4 mL in 1 VIAL, MULTI-DOSE INJECTION, SOLUTION 4 22 63459-348-04 Bendeka 1 in 1 CARTON INJECTION, SOLUTION 1 22
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63459-348 BENDEKA (BENDAMUSTINE HYDROCHLORIDE) INJECTION, SOLUTION [TEVA PHARMACEUTICALS USA, INC.] 22 Current NDC, Legacy NDC, 2 package rows 20240124_ace9a43b-f9bd-4896-abfe-0ef4fec67ddf.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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Bendeka BENDAMUSTINE HYDROCHLORIDE Teva Pharmaceuticals USA, Inc. ace9a43b-f9bd-4896-abfe-0ef4fec67ddf 2024-01-19 Warnings, Adverse reactions Exact identifier application applno (NDA): 208194 application number: NDA208194 ndc (product): 63459-348
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 63459-348-04 63459034804 1 VIAL, MULTI-DOSE in 1 CARTON (63459-348-04) / 4 mL in 1 VIAL, MULTI-DOSE 2015-12-08 0000-00-00 No No Current