Home DailyMed ae9652c3-0f12-440e-9b77-4035ea016e57 National Council for Prescription Drug Programs indexing - billing unit Drug label information. FDA.report displays public Structured Product Labeling data from DailyMed and legacy FDA.report DailyMed cache rows. This page is not medical advice, prescribing advice, or a substitute for the official label reviewed by a qualified healthcare professional. Labeling can change; when a current hydrated DailyMed SPL record is available, FDA.report shows that newer record before legacy cached files.
Manufacturer National Council for Prescription Drug Programs
Effective date 2012-07-24
Label type Indexing - Billing Unit
Version 1
Source full-release
Hydrated at 2026-06-05 02:28:08 Orange Book application contexts# All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.
Orange Book application contexts page 1 of 1 · 1 matching rows.
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 4 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N022249-001 TREANDA BENDAMUSTINE HYDROCHLORIDE 100MG/VIAL POWDER / INTRAVENOUS AP RLD, RS 2008-03-20 N022249-002 TREANDA BENDAMUSTINE HYDROCHLORIDE 25MG/VIAL POWDER / INTRAVENOUS AP RLD, RS 2009-05-01 N022249-003 TREANDA BENDAMUSTINE HYDROCHLORIDE 45MG/0.5ML (90MG/ML) SOLUTION / INTRAVENOUS RLD 2013-09-13 N022249-004 TREANDA BENDAMUSTINE HYDROCHLORIDE 180MG/2ML (90MG/ML) SOLUTION / INTRAVENOUS RLD 2013-09-13
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
Orange Book patents# Current patent rows page 1 of 1 · 46 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N022249-001 8609863 2026-01-12 Drug product 2014-01-16 N022249-001 8791270 2026-01-12 U-1542 Drug product 2014-07-29 N022249-001 8895756 2026-01-12 Drug product 2014-11-26 N022249-001 8609863*PED 2026-07-12 Pediatric extension N022249-001 8791270*PED 2026-07-12 Pediatric extension N022249-001 8895756*PED 2026-07-12 Pediatric extension N022249-001 8445524 2029-03-26 U-1402 Drug substance, Drug product 2013-06-04 N022249-001 8669279 2029-03-26 U-1402 Drug product 2014-10-30 N022249-001 8883836 2029-03-26 U-1402 Drug product 2014-11-13 N022249-001 9533955 2029-03-26 U-1949 Drug product N022249-001 9533955 2029-03-26 U-1952 Drug product N022249-001 8445524*PED 2029-09-26 Pediatric extension N022249-001 8669279*PED 2029-09-26 Pediatric extension N022249-001 8883836*PED 2029-09-26 Pediatric extension N022249-001 9533955*PED 2029-09-26 Pediatric extension N022249-001 8436190 2030-10-26 Drug product 2013-06-04 N022249-001 8436190*PED 2031-04-26 Pediatric extension N022249-002 8609863 2026-01-12 Drug product 2014-01-16 N022249-002 8791270 2026-01-12 U-1542 Drug product 2014-07-29 N022249-002 8895756 2026-01-12 Drug product 2014-11-26 N022249-002 8609863*PED 2026-07-12 Pediatric extension N022249-002 8791270*PED 2026-07-12 Pediatric extension N022249-002 8895756*PED 2026-07-12 Pediatric extension N022249-002 8445524 2029-03-26 U-1402 Drug substance, Drug product 2013-06-04 N022249-002 8669279 2029-03-26 U-1402 Drug product 2014-10-30 N022249-002 8883836 2029-03-26 U-1402 Drug product 2014-11-13 N022249-002 9533955 2029-03-26 U-1949 Drug product 2017-01-13 N022249-002 9533955 2029-03-26 U-1952 Drug product 2017-01-13 N022249-002 8445524*PED 2029-09-26 Pediatric extension N022249-002 8669279*PED 2029-09-26 Pediatric extension N022249-002 8883836*PED 2029-09-26 Pediatric extension N022249-002 9533955*PED 2029-09-26 Pediatric extension N022249-002 8436190 2030-10-26 Drug product 2013-06-04 N022249-002 8436190*PED 2031-04-26 Pediatric extension N022249-003 8791270 2026-01-12 U-1542 Drug product 2014-12-09 N022249-003 8791270*PED 2026-07-12 Pediatric extension N022249-003 8445524 2029-03-26 Drug substance 2013-09-17 N022249-003 8344006 2029-09-23 U-1402 Drug product N022249-003 8445524*PED 2029-09-26 Pediatric extension N022249-003 8344006*PED 2030-03-23 Pediatric extension N022249-004 8791270 2026-01-12 U-1542 Drug product 2014-12-09 N022249-004 8791270*PED 2026-07-12 Pediatric extension N022249-004 8445524 2029-03-26 Drug substance 2013-09-17 N022249-004 8344006 2029-09-23 U-1402 Drug product N022249-004 8445524*PED 2029-09-26 Pediatric extension N022249-004 8344006*PED 2030-03-23 Pediatric extension
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 5 · 172 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 2026-09-14 22:38:34 2026-08 N022249-001 TREANDA 100MG/VIAL POWDER / INTRAVENOUS AP RLD, RS 2008-03-20 84e616aacf4f…2026-09-14 22:38:34 2026-08 N022249-002 TREANDA 25MG/VIAL POWDER / INTRAVENOUS AP RLD, RS 2009-05-01 84e616aacf4f…2026-09-14 22:38:34 2026-08 N022249-003 TREANDA 45MG/0.5ML (90MG/ML) SOLUTION / INTRAVENOUS RLD 2013-09-13 84e616aacf4f…2026-09-14 22:38:34 2026-08 N022249-004 TREANDA 180MG/2ML (90MG/ML) SOLUTION / INTRAVENOUS RLD 2013-09-13 84e616aacf4f…2026-08-18 06:07:40 2026-07 N022249-001 TREANDA 100MG/VIAL POWDER / INTRAVENOUS AP RLD, RS 2008-03-20 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022249-002 TREANDA 25MG/VIAL POWDER / INTRAVENOUS AP RLD, RS 2009-05-01 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022249-003 TREANDA 45MG/0.5ML (90MG/ML) SOLUTION / INTRAVENOUS RLD 2013-09-13 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022249-004 TREANDA 180MG/2ML (90MG/ML) SOLUTION / INTRAVENOUS RLD 2013-09-13 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N022249-001 TREANDA 100MG/VIAL POWDER / INTRAVENOUS AP RLD, RS 2008-03-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022249-002 TREANDA 25MG/VIAL POWDER / INTRAVENOUS AP RLD, RS 2009-05-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022249-003 TREANDA 45MG/0.5ML (90MG/ML) SOLUTION / INTRAVENOUS RLD 2013-09-13 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022249-004 TREANDA 180MG/2ML (90MG/ML) SOLUTION / INTRAVENOUS RLD 2013-09-13 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022249-001 TREANDA 100MG/VIAL POWDER / INTRAVENOUS AP RLD, RS 2008-03-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022249-002 TREANDA 25MG/VIAL POWDER / INTRAVENOUS AP RLD, RS 2009-05-01 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022249-003 TREANDA 45MG/0.5ML (90MG/ML) SOLUTION / INTRAVENOUS RLD 2013-09-13 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022249-004 TREANDA 180MG/2ML (90MG/ML) SOLUTION / INTRAVENOUS RLD 2013-09-13 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N022249-001 TREANDA 100MG/VIAL POWDER / INTRAVENOUS AP RLD, RS 2008-03-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022249-002 TREANDA 25MG/VIAL POWDER / INTRAVENOUS AP RLD, RS 2009-05-01 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022249-003 TREANDA 45MG/0.5ML (90MG/ML) SOLUTION / INTRAVENOUS RLD 2013-09-13 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022249-004 TREANDA 180MG/2ML (90MG/ML) SOLUTION / INTRAVENOUS RLD 2013-09-13 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022249-001 TREANDA 100MG/VIAL POWDER / INTRAVENOUS AP RLD, RS 2008-03-20 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022249-002 TREANDA 25MG/VIAL POWDER / INTRAVENOUS AP RLD, RS 2009-05-01 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022249-003 TREANDA 45MG/0.5ML (90MG/ML) SOLUTION / INTRAVENOUS RLD 2013-09-13 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022249-004 TREANDA 180MG/2ML (90MG/ML) SOLUTION / INTRAVENOUS RLD 2013-09-13 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022249-001 TREANDA 100MG/VIAL POWDER / INTRAVENOUS AP RLD, RS 2008-03-20 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022249-002 TREANDA 25MG/VIAL POWDER / INTRAVENOUS AP RLD, RS 2009-05-01 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022249-003 TREANDA 45MG/0.5ML (90MG/ML) SOLUTION / INTRAVENOUS RLD 2013-09-13 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022249-004 TREANDA 180MG/2ML (90MG/ML) SOLUTION / INTRAVENOUS RLD 2013-09-13 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022249-001 TREANDA 100MG/VIAL POWDER / INTRAVENOUS AP RLD, RS 2008-03-20 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022249-002 TREANDA 25MG/VIAL POWDER / INTRAVENOUS AP RLD, RS 2009-05-01 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022249-003 TREANDA 45MG/0.5ML (90MG/ML) SOLUTION / INTRAVENOUS RLD 2013-09-13 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022249-004 TREANDA 180MG/2ML (90MG/ML) SOLUTION / INTRAVENOUS RLD 2013-09-13 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022249-001 TREANDA 100MG/VIAL POWDER / INTRAVENOUS AP RLD, RS 2008-03-20 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022249-002 TREANDA 25MG/VIAL POWDER / INTRAVENOUS AP RLD, RS 2009-05-01 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022249-003 TREANDA 45MG/0.5ML (90MG/ML) SOLUTION / INTRAVENOUS RLD 2013-09-13 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022249-004 TREANDA 180MG/2ML (90MG/ML) SOLUTION / INTRAVENOUS RLD 2013-09-13 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022249-001 TREANDA 100MG/VIAL POWDER / IV (INFUSION) AP RLD, RS 2008-03-20 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022249-002 TREANDA 25MG/VIAL POWDER / IV (INFUSION) AP RLD, RS 2009-05-01 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022249-003 TREANDA 45MG/0.5ML (90MG/ML) SOLUTION / IV (INFUSION) RLD 2013-09-13 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022249-004 TREANDA 180MG/2ML (90MG/ML) SOLUTION / IV (INFUSION) RLD 2013-09-13 5bbf6a4d5a75…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 52 observed states.
Observed Orange Book patent history# Patent history page 1 of 49 · 1,942 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-09-14 22:38:34 2026-08 N022249-001 8609863 2026-01-12 Drug product 2014-01-16 84e616aacf4f…2026-09-14 22:38:34 2026-08 N022249-001 8791270 2026-01-12 U-1542 Drug product 2014-07-29 84e616aacf4f…2026-09-14 22:38:34 2026-08 N022249-001 8895756 2026-01-12 Drug product 2014-11-26 84e616aacf4f…2026-09-14 22:38:34 2026-08 N022249-001 8609863*PED 2026-07-12 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N022249-001 8791270*PED 2026-07-12 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N022249-001 8895756*PED 2026-07-12 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N022249-001 8445524 2029-03-26 U-1402 Drug substance, Drug product 2013-06-04 84e616aacf4f…2026-09-14 22:38:34 2026-08 N022249-001 8669279 2029-03-26 U-1402 Drug product 2014-10-30 84e616aacf4f…2026-09-14 22:38:34 2026-08 N022249-001 8883836 2029-03-26 U-1402 Drug product 2014-11-13 84e616aacf4f…2026-09-14 22:38:34 2026-08 N022249-001 9533955 2029-03-26 U-1952 Drug product 84e616aacf4f…2026-09-14 22:38:34 2026-08 N022249-001 9533955 2029-03-26 U-1949 Drug product 84e616aacf4f…2026-09-14 22:38:34 2026-08 N022249-001 8445524*PED 2029-09-26 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N022249-001 8669279*PED 2029-09-26 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N022249-001 8883836*PED 2029-09-26 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N022249-001 9533955*PED 2029-09-26 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N022249-001 8436190 2030-10-26 Drug product 2013-06-04 84e616aacf4f…2026-09-14 22:38:34 2026-08 N022249-001 8436190*PED 2031-04-26 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N022249-002 8609863 2026-01-12 Drug product 2014-01-16 84e616aacf4f…2026-09-14 22:38:34 2026-08 N022249-002 8791270 2026-01-12 U-1542 Drug product 2014-07-29 84e616aacf4f…2026-09-14 22:38:34 2026-08 N022249-002 8895756 2026-01-12 Drug product 2014-11-26 84e616aacf4f…2026-09-14 22:38:34 2026-08 N022249-002 8609863*PED 2026-07-12 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N022249-002 8791270*PED 2026-07-12 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N022249-002 8895756*PED 2026-07-12 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N022249-002 8445524 2029-03-26 U-1402 Drug substance, Drug product 2013-06-04 84e616aacf4f…2026-09-14 22:38:34 2026-08 N022249-002 8669279 2029-03-26 U-1402 Drug product 2014-10-30 84e616aacf4f…2026-09-14 22:38:34 2026-08 N022249-002 8883836 2029-03-26 U-1402 Drug product 2014-11-13 84e616aacf4f…2026-09-14 22:38:34 2026-08 N022249-002 9533955 2029-03-26 U-1952 Drug product 2017-01-13 84e616aacf4f…2026-09-14 22:38:34 2026-08 N022249-002 9533955 2029-03-26 U-1949 Drug product 2017-01-13 84e616aacf4f…2026-09-14 22:38:34 2026-08 N022249-002 8445524*PED 2029-09-26 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N022249-002 8669279*PED 2029-09-26 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N022249-002 8883836*PED 2029-09-26 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N022249-002 9533955*PED 2029-09-26 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N022249-002 8436190 2030-10-26 Drug product 2013-06-04 84e616aacf4f…2026-09-14 22:38:34 2026-08 N022249-002 8436190*PED 2031-04-26 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N022249-003 8791270 2026-01-12 U-1542 Drug product 2014-12-09 84e616aacf4f…2026-09-14 22:38:34 2026-08 N022249-003 8791270*PED 2026-07-12 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N022249-003 8445524 2029-03-26 Drug substance 2013-09-17 84e616aacf4f…2026-09-14 22:38:34 2026-08 N022249-003 8344006 2029-09-23 U-1402 Drug product 84e616aacf4f…2026-09-14 22:38:34 2026-08 N022249-003 8445524*PED 2029-09-26 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N022249-003 8344006*PED 2030-03-23 Pediatric extension 84e616aacf4f…
Observed Orange Book exclusivity history# Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.