Home NDC 42367-521 BELRAPZO
Product NDC 42367-521
11-digit product format 423670521
Labeler code 42367
Product ID 42367-521_7e2a2a05-9122-41c0-acf0-a1231a57434e
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name bendamustine hydrochloride
Dosage form INJECTION
Route INTRAVENOUS
Labeler Eagle Pharmaceuticals, Inc
Application NDA205580
Marketing category NDA
Marketing start 2019-06-03
Substance BENDAMUSTINE HYDROCHLORIDE
Active strength 100 mg/4mL
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 N205580-001 BELRAPZO BENDAMUSTINE HYDROCHLORIDE 100MG/4ML (25MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2018-05-15
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N205580-001 AP
Orange Book patents# Current patent rows page 1 of 1 · 20 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N205580-001 8791270 2026-01-12 U-1971 Drug product 2018-08-01 N205580-001 8791270 2026-01-12 U-1972 Drug product 2018-08-01 N205580-001 10010533 2031-01-28 Drug product 2018-07-03 N205580-001 11103483 2031-01-28 U-1971 Drug product 2021-08-31 N205580-001 11103483 2031-01-28 U-1972 Drug product 2021-08-31 N205580-001 11844783 2031-01-28 U-1542 2023-12-19 N205580-001 11844783 2031-01-28 U-1971 2023-12-19 N205580-001 11844783 2031-01-28 U-1972 2023-12-19 N205580-001 11872214 2031-01-28 Drug product 2024-01-16 N205580-001 12138248 2031-01-28 Drug product 2025-01-27 N205580-001 12350257 2031-01-28 U-1542 Drug product 2025-07-14 N205580-001 12350257 2031-01-28 U-1971 Drug product 2025-07-14 N205580-001 12350257 2031-01-28 U-1972 Drug product 2025-07-14 N205580-001 9265831 2031-01-28 Drug product 2018-08-01 N205580-001 9572796 2031-01-28 U-1971 Drug product 2018-08-01 N205580-001 9572796 2031-01-28 U-1972 Drug product 2018-08-01 N205580-001 9572797 2031-01-28 U-1971 2018-08-01 N205580-001 9572797 2031-01-28 U-1972 2018-08-01 N205580-001 8609707 2031-08-11 U-1971 Drug product 2018-08-01 N205580-001 8609707 2031-08-11 U-1972 Drug product 2018-08-01
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 · 42 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 N205580-001 BELRAPZO 100MG/4ML (25MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2018-05-15 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N205580-001 BELRAPZO 100MG/4ML (25MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2018-05-15 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205580-001 BELRAPZO 100MG/4ML (25MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2018-05-15 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N205580-001 BELRAPZO 100MG/4ML (25MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2018-05-15 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N205580-001 BELRAPZO 100MG/4ML (25MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2018-05-15 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N205580-001 BELRAPZO 100MG/4ML (25MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2018-05-15 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N205580-001 BELRAPZO 100MG/4ML (25MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2018-05-15 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N205580-001 BELRAPZO 100MG/4ML (25MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2018-05-15 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N205580-001 BELRAPZO 100MG/4ML (25MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2018-05-15 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N205580-001 BELRAPZO 100MG/4ML (25MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2018-05-15 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N205580-001 BELRAPZO 100MG/4ML (25MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2018-05-15 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N205580-001 BELRAPZO 100MG/4ML (25MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2018-05-15 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N205580-001 BELRAPZO 100MG/4ML (25MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2018-05-15 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N205580-001 BELRAPZO 100MG/4ML (25MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2018-05-15 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N205580-001 BELRAPZO 100MG/4ML (25MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2018-05-15 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N205580-001 BELRAPZO 100MG/4ML (25MG/ML) SOLUTION / IV (INFUSION) RLD, RS 2018-05-15 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N205580-001 BELRAPZO 100MG/4ML (25MG/ML) SOLUTION / IV (INFUSION) RLD, RS 2018-05-15 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N205580-001 BELRAPZO 100MG/4ML (25MG/ML) SOLUTION / IV (INFUSION) RLD, RS 2018-05-15 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N205580-001 BELRAPZO 100MG/4ML (25MG/ML) SOLUTION / IV (INFUSION) RLD, RS 2018-05-15 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N205580-001 BELRAPZO 100MG/4ML (25MG/ML) SOLUTION / IV (INFUSION) RLD, RS 2018-05-15 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N205580-001 BELRAPZO 100MG/4ML (25MG/ML) SOLUTION / IV (INFUSION) RLD, RS 2018-05-15 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N205580-001 BELRAPZO 100MG/4ML (25MG/ML) SOLUTION / IV (INFUSION) RLD, RS 2018-05-15 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N205580-001 BELRAPZO 100MG/4ML (25MG/ML) SOLUTION / IV (INFUSION) RLD, RS 2018-05-15 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N205580-001 BELRAPZO 100MG/4ML (25MG/ML) SOLUTION / IV (INFUSION) RLD, RS 2018-05-15 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N205580-001 BELRAPZO 100MG/4ML (25MG/ML) SOLUTION / IV (INFUSION) RLD, RS 2018-05-15 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N205580-001 BELRAPZO 100MG/4ML (25MG/ML) SOLUTION / IV (INFUSION) RLD, RS 2018-05-15 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N205580-001 BELRAPZO 100MG/4ML (25MG/ML) SOLUTION / IV (INFUSION) RLD, RS 2018-05-15 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N205580-001 BELRAPZO 100MG/4ML (25MG/ML) SOLUTION / IV (INFUSION) RLD, RS 2018-05-15 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N205580-001 BELRAPZO 100MG/4ML (25MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2018-05-15 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N205580-001 BELRAPZO 100MG/4ML (25MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2018-05-15 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N205580-001 BELRAPZO 100MG/4ML (25MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2018-05-15 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N205580-001 BELRAPZO 100MG/4ML (25MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2018-05-15 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N205580-001 BELRAPZO 100MG/4ML (25MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2018-05-15 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N205580-001 BELRAPZO 100MG/4ML (25MG/ML) SOLUTION / IV (INFUSION) RLD, RS 2018-05-15 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N205580-001 BELRAPZO 100MG/4ML (25MG/ML) SOLUTION / IV (INFUSION) RLD, RS 2018-05-15 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N205580-001 BELRAPZO 100MG/4ML (25MG/ML) SOLUTION / IV (INFUSION) RLD, RS 2018-05-15 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N205580-001 BELRAPZO 100MG/4ML (25MG/ML) SOLUTION / IV (INFUSION) RLD, RS 2018-05-15 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N205580-001 BELRAPZO 100MG/4ML (25MG/ML) SOLUTION / IV (INFUSION) RLD, RS 2018-05-15 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N205580-001 BELRAPZO 100MG/4ML (25MG/ML) SOLUTION / IV (INFUSION) RLD, RS 2018-05-15 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N205580-001 BELRAPZO 100MG/4ML (25MG/ML) SOLUTION / IV (INFUSION) RLD, RS 2018-05-15 e64feba35796…
Observed Orange Book normalized TE history# Observed Orange Book patent history# Patent history page 1 of 15 · 582 observed states.
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 N205580-001 8791270 2026-01-12 U-1971 Drug product 2018-08-01 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N205580-001 8791270 2026-01-12 U-1972 Drug product 2018-08-01 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N205580-001 10010533 2031-01-28 Drug product 2018-07-03 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N205580-001 11103483 2031-01-28 U-1971 Drug product 2021-08-31 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N205580-001 11103483 2031-01-28 U-1972 Drug product 2021-08-31 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N205580-001 11844783 2031-01-28 U-1542 2023-12-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N205580-001 11844783 2031-01-28 U-1971 2023-12-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N205580-001 11844783 2031-01-28 U-1972 2023-12-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N205580-001 11872214 2031-01-28 Drug product 2024-01-16 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N205580-001 12138248 2031-01-28 Drug product 2025-01-27 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N205580-001 12350257 2031-01-28 U-1542 Drug product 2025-07-14 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N205580-001 12350257 2031-01-28 U-1971 Drug product 2025-07-14 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N205580-001 12350257 2031-01-28 U-1972 Drug product 2025-07-14 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N205580-001 9265831 2031-01-28 Drug product 2018-08-01 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N205580-001 9572796 2031-01-28 U-1971 Drug product 2018-08-01 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N205580-001 9572796 2031-01-28 U-1972 Drug product 2018-08-01 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N205580-001 9572797 2031-01-28 U-1972 2018-08-01 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N205580-001 9572797 2031-01-28 U-1971 2018-08-01 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N205580-001 8609707 2031-08-11 U-1971 Drug product 2018-08-01 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N205580-001 8609707 2031-08-11 U-1972 Drug product 2018-08-01 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N205580-001 8791270 2026-01-12 U-1971 Drug product 2018-08-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205580-001 8791270 2026-01-12 U-1972 Drug product 2018-08-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205580-001 10010533 2031-01-28 Drug product 2018-07-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205580-001 11103483 2031-01-28 U-1971 Drug product 2021-08-31 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205580-001 11103483 2031-01-28 U-1972 Drug product 2021-08-31 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205580-001 11844783 2031-01-28 U-1542 2023-12-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205580-001 11844783 2031-01-28 U-1971 2023-12-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205580-001 11844783 2031-01-28 U-1972 2023-12-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205580-001 11872214 2031-01-28 Drug product 2024-01-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205580-001 12138248 2031-01-28 Drug product 2025-01-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205580-001 12350257 2031-01-28 U-1542 Drug product 2025-07-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205580-001 12350257 2031-01-28 U-1971 Drug product 2025-07-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205580-001 12350257 2031-01-28 U-1972 Drug product 2025-07-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205580-001 9265831 2031-01-28 Drug product 2018-08-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205580-001 9572796 2031-01-28 U-1971 Drug product 2018-08-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205580-001 9572796 2031-01-28 U-1972 Drug product 2018-08-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205580-001 9572797 2031-01-28 U-1972 2018-08-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205580-001 9572797 2031-01-28 U-1971 2018-08-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205580-001 8609707 2031-08-11 U-1971 Drug product 2018-08-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205580-001 8609707 2031-08-11 U-1972 Drug product 2018-08-01 011fe1cb6892…
Observed Orange Book exclusivity history# Captured, Edition, Application-product table Captured Edition Application-product Exclusivity code Expiration Source SHA-256 2023-01-26 05:58 UTC 2023-01 N205580-001 ODE* 2022-12-07 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N205580-001 ODE* 2022-12-07 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N205580-001 ODE* 2022-12-07 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N205580-001 ODE* 2022-12-07 e64feba35796…
Additional Listing Data#
Finished product Yes
Brand name base BELRAPZO
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength BENDAMUSTINE HYDROCHLORIDE 100 mg/4mL
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 2178266 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 42367-521-25 BELRAPZO 1 in 1 CARTON INJECTION 1 11 42367-521-25 BELRAPZO 4 mL in 1 VIAL, MULTI-DOSE INJECTION 4 11
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 42367-521 BELRAPZO (BENDAMUSTINE HYDROCHLORIDE) INJECTION [EAGLE PHARMACEUTICALS, INC] 11 Current NDC, Legacy NDC, 2 package rows 20241003_9759a4ae-82ca-40cf-9c02-e1cadb21cbdc.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 BELRAPZO BENDAMUSTINE HYDROCHLORIDE Eagle Pharmaceuticals, Inc 9759a4ae-82ca-40cf-9c02-e1cadb21cbdc 2024-09-23 Warnings, Adverse reactions Exact identifier application applno (NDA): 205580 application number: NDA205580 ndc (product): 42367-521
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 42367-521-25 42367052125 1 VIAL, MULTI-DOSE in 1 CARTON (42367-521-25) / 4 mL in 1 VIAL, MULTI-DOSE 2019-06-03 0000-00-00 No No Current