Home NDC 63459-391 TREANDA
Product NDC 63459-391
11-digit product format 634590391
Labeler code 63459
Product ID 63459-391_6f14f826-ae33-48f7-8a5a-413412030c2d
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Bendamustine Hydrochloride
Dosage form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route INTRAVENOUS
Labeler Cephalon, LLC
Application NDA022249
Marketing category NDA
Marketing start 2008-03-31
Substance BENDAMUSTINE HYDROCHLORIDE
Active strength 100 mg/20mL
Pharmacologic classes Alkylating Activity [MoA], Alkylating Drug [EPC]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
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 · 176 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 2026-10-15 13:18:30 2026-09 N022249-001 TREANDA 100MG/VIAL POWDER / INTRAVENOUS AP RLD, RS 2008-03-20 c2088c7a36db…2026-10-15 13:18:30 2026-09 N022249-002 TREANDA 25MG/VIAL POWDER / INTRAVENOUS AP RLD, RS 2009-05-01 c2088c7a36db…2026-10-15 13:18:30 2026-09 N022249-003 TREANDA 45MG/0.5ML (90MG/ML) SOLUTION / INTRAVENOUS RLD 2013-09-13 c2088c7a36db…2026-10-15 13:18:30 2026-09 N022249-004 TREANDA 180MG/2ML (90MG/ML) SOLUTION / INTRAVENOUS RLD 2013-09-13 c2088c7a36db…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…
Observed Orange Book normalized TE history# Normalized TE history page 2 of 2 · 54 observed states.
Observed Orange Book patent history# Patent history page 1 of 50 · 1,988 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-10-15 13:18:30 2026-09 N022249-001 8609863 2026-01-12 Drug product 2014-01-16 c2088c7a36db…2026-10-15 13:18:30 2026-09 N022249-001 8791270 2026-01-12 U-1542 Drug product 2014-07-29 c2088c7a36db…2026-10-15 13:18:30 2026-09 N022249-001 8895756 2026-01-12 Drug product 2014-11-26 c2088c7a36db…2026-10-15 13:18:30 2026-09 N022249-001 8609863*PED 2026-07-12 Pediatric extension c2088c7a36db…2026-10-15 13:18:30 2026-09 N022249-001 8791270*PED 2026-07-12 Pediatric extension c2088c7a36db…2026-10-15 13:18:30 2026-09 N022249-001 8895756*PED 2026-07-12 Pediatric extension c2088c7a36db…2026-10-15 13:18:30 2026-09 N022249-001 8445524 2029-03-26 U-1402 Drug substance, Drug product 2013-06-04 c2088c7a36db…2026-10-15 13:18:30 2026-09 N022249-001 8669279 2029-03-26 U-1402 Drug product 2014-10-30 c2088c7a36db…2026-10-15 13:18:30 2026-09 N022249-001 8883836 2029-03-26 U-1402 Drug product 2014-11-13 c2088c7a36db…2026-10-15 13:18:30 2026-09 N022249-001 9533955 2029-03-26 U-1952 Drug product c2088c7a36db…2026-10-15 13:18:30 2026-09 N022249-001 9533955 2029-03-26 U-1949 Drug product c2088c7a36db…2026-10-15 13:18:30 2026-09 N022249-001 8445524*PED 2029-09-26 Pediatric extension c2088c7a36db…2026-10-15 13:18:30 2026-09 N022249-001 8669279*PED 2029-09-26 Pediatric extension c2088c7a36db…2026-10-15 13:18:30 2026-09 N022249-001 8883836*PED 2029-09-26 Pediatric extension c2088c7a36db…2026-10-15 13:18:30 2026-09 N022249-001 9533955*PED 2029-09-26 Pediatric extension c2088c7a36db…2026-10-15 13:18:30 2026-09 N022249-001 8436190 2030-10-26 Drug product 2013-06-04 c2088c7a36db…2026-10-15 13:18:30 2026-09 N022249-001 8436190*PED 2031-04-26 Pediatric extension c2088c7a36db…2026-10-15 13:18:30 2026-09 N022249-002 8609863 2026-01-12 Drug product 2014-01-16 c2088c7a36db…2026-10-15 13:18:30 2026-09 N022249-002 8791270 2026-01-12 U-1542 Drug product 2014-07-29 c2088c7a36db…2026-10-15 13:18:30 2026-09 N022249-002 8895756 2026-01-12 Drug product 2014-11-26 c2088c7a36db…2026-10-15 13:18:30 2026-09 N022249-002 8609863*PED 2026-07-12 Pediatric extension c2088c7a36db…2026-10-15 13:18:30 2026-09 N022249-002 8791270*PED 2026-07-12 Pediatric extension c2088c7a36db…2026-10-15 13:18:30 2026-09 N022249-002 8895756*PED 2026-07-12 Pediatric extension c2088c7a36db…2026-10-15 13:18:30 2026-09 N022249-002 8445524 2029-03-26 U-1402 Drug substance, Drug product 2013-06-04 c2088c7a36db…2026-10-15 13:18:30 2026-09 N022249-002 8669279 2029-03-26 U-1402 Drug product 2014-10-30 c2088c7a36db…2026-10-15 13:18:30 2026-09 N022249-002 8883836 2029-03-26 U-1402 Drug product 2014-11-13 c2088c7a36db…2026-10-15 13:18:30 2026-09 N022249-002 9533955 2029-03-26 U-1952 Drug product 2017-01-13 c2088c7a36db…2026-10-15 13:18:30 2026-09 N022249-002 9533955 2029-03-26 U-1949 Drug product 2017-01-13 c2088c7a36db…2026-10-15 13:18:30 2026-09 N022249-002 8445524*PED 2029-09-26 Pediatric extension c2088c7a36db…2026-10-15 13:18:30 2026-09 N022249-002 8669279*PED 2029-09-26 Pediatric extension c2088c7a36db…2026-10-15 13:18:30 2026-09 N022249-002 8883836*PED 2029-09-26 Pediatric extension c2088c7a36db…2026-10-15 13:18:30 2026-09 N022249-002 9533955*PED 2029-09-26 Pediatric extension c2088c7a36db…2026-10-15 13:18:30 2026-09 N022249-002 8436190 2030-10-26 Drug product 2013-06-04 c2088c7a36db…2026-10-15 13:18:30 2026-09 N022249-002 8436190*PED 2031-04-26 Pediatric extension c2088c7a36db…2026-10-15 13:18:30 2026-09 N022249-003 8791270 2026-01-12 U-1542 Drug product 2014-12-09 c2088c7a36db…2026-10-15 13:18:30 2026-09 N022249-003 8791270*PED 2026-07-12 Pediatric extension c2088c7a36db…2026-10-15 13:18:30 2026-09 N022249-003 8445524 2029-03-26 Drug substance 2013-09-17 c2088c7a36db…2026-10-15 13:18:30 2026-09 N022249-003 8344006 2029-09-23 U-1402 Drug product c2088c7a36db…2026-10-15 13:18:30 2026-09 N022249-003 8445524*PED 2029-09-26 Pediatric extension c2088c7a36db…2026-10-15 13:18:30 2026-09 N022249-003 8344006*PED 2030-03-23 Pediatric extension c2088c7a36db…
Observed Orange Book exclusivity history# Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base TREANDA
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength BENDAMUSTINE HYDROCHLORIDE 100 mg/20mL
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 63459-391-20 TREANDA 1 in 1 CARTON INJECTION, POWDER, LYOPHILIZED, 1 26 63459-391-20 TREANDA 20 mL in 1 VIAL, SINGLE-DOSE INJECTION, POWDER, LYOPHILIZED, 20 26
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded BENDAMUSTINE HYDROCHLORIDE ACTIVE INGREDIENT 981Y8SX18M TREANDA (BENDAMUSTINE HYDROCHLORIDE) INJECTION, SOLUTION, CONCENTRATE TREANDA (BENDAMUSTINE HYDROCHLORIDE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [CEPHALON, INCORPORATED] 15 BENDAMUSTINE ACTIVE MOIETY 9266D9P3PQ TREANDA (BENDAMUSTINE HYDROCHLORIDE) INJECTION, SOLUTION, CONCENTRATE TREANDA (BENDAMUSTINE HYDROCHLORIDE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [CEPHALON, INCORPORATED] 15 MANNITOL INACTIVE INGREDIENT 3OWL53L36A TREANDA (BENDAMUSTINE HYDROCHLORIDE) INJECTION, SOLUTION, CONCENTRATE TREANDA (BENDAMUSTINE HYDROCHLORIDE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [CEPHALON, INCORPORATED] 15 N,N-DIMETHYLACETAMIDE INACTIVE INGREDIENT JCV5VDB3HY TREANDA (BENDAMUSTINE HYDROCHLORIDE) INJECTION, SOLUTION, CONCENTRATE TREANDA (BENDAMUSTINE HYDROCHLORIDE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [CEPHALON, INCORPORATED] 15 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 TREANDA (BENDAMUSTINE HYDROCHLORIDE) INJECTION, SOLUTION, CONCENTRATE TREANDA (BENDAMUSTINE HYDROCHLORIDE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [CEPHALON, INCORPORATED] 15
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63459-391 TREANDA (BENDAMUSTINE HYDROCHLORIDE) INJECTION, SOLUTION, CONCENTRATE TREANDA (BENDAMUSTINE HYDROCHLORIDE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [CEPHALON, LLC] 26 Current NDC, Legacy NDC, 2 package rows 20221029_39d53698-57fa-7c99-fc5b-f52a55684826.zip
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 63459-391-20 63459039120 1 VIAL, SINGLE-DOSE in 1 CARTON (63459-391-20) / 20 mL in 1 VIAL, SINGLE-DOSE 2008-03-31 0000-00-00 No No Current