TREANDA

Product NDC: 63459-391
11-digit product format: 634590391
Labeler code: 63459
Product ID: 63459-391_77ae475d-2d59-4fe2-8de7-833b6fc9d51a
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: 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 · 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.

Application-product, TE code table
Application-product	TE code
N022249-001	AP
N022249-002	AP

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 · 164 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	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…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022249-001	TREANDA	100MG/VIAL	POWDER / INTRAVENOUS	AP	RLD, RS	2008-03-20	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022249-002	TREANDA	25MG/VIAL	POWDER / INTRAVENOUS	AP	RLD, RS	2009-05-01	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022249-003	TREANDA	45MG/0.5ML (90MG/ML)	SOLUTION / INTRAVENOUS		RLD	2013-09-13	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022249-004	TREANDA	180MG/2ML (90MG/ML)	SOLUTION / INTRAVENOUS		RLD	2013-09-13	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022249-001	TREANDA	100MG/VIAL	POWDER / IV (INFUSION)	AP	RLD, RS	2008-03-20	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022249-002	TREANDA	25MG/VIAL	POWDER / IV (INFUSION)	AP	RLD, RS	2009-05-01	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022249-003	TREANDA	45MG/0.5ML (90MG/ML)	SOLUTION / IV (INFUSION)		RLD	2013-09-13	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022249-004	TREANDA	180MG/2ML (90MG/ML)	SOLUTION / IV (INFUSION)		RLD	2013-09-13	`d06236e962d9…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 48 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N022249-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022249-002	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022249-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022249-002	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022249-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022249-002	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022249-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022249-002	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022249-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022249-002	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022249-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022249-002	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022249-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022249-002	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022249-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022249-002	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022249-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022249-002	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022249-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022249-002	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022249-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022249-002	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022249-001	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022249-002	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022249-001	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022249-002	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022249-001	AP	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N022249-002	AP	1	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N022249-001	AP	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N022249-002	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N022249-001	AP	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N022249-002	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N022249-001	AP	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N022249-002	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N022249-001	AP	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N022249-002	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N022249-001	AP	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N022249-002	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N022249-001	AP	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N022249-002	AP	1	`a67488948f0b…`

Observed Orange Book patent history#

Patent history page 1 of 47 · 1,850 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	N022249-001	8609863	2026-01-12		Drug product	2014-01-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022249-001	8791270	2026-01-12	U-1542	Drug product	2014-07-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022249-001	8895756	2026-01-12		Drug product	2014-11-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022249-001	8609863*PED	2026-07-12		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022249-001	8791270*PED	2026-07-12		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022249-001	8895756*PED	2026-07-12		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022249-001	8445524	2029-03-26	U-1402	Drug substance, Drug product	2013-06-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022249-001	8669279	2029-03-26	U-1402	Drug product	2014-10-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022249-001	8883836	2029-03-26	U-1402	Drug product	2014-11-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022249-001	9533955	2029-03-26	U-1952	Drug product		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022249-001	9533955	2029-03-26	U-1949	Drug product		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022249-001	8445524*PED	2029-09-26		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022249-001	8669279*PED	2029-09-26		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022249-001	8883836*PED	2029-09-26		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022249-001	9533955*PED	2029-09-26		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022249-001	8436190	2030-10-26		Drug product	2013-06-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022249-001	8436190*PED	2031-04-26		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022249-002	8609863	2026-01-12		Drug product	2014-01-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022249-002	8791270	2026-01-12	U-1542	Drug product	2014-07-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022249-002	8895756	2026-01-12		Drug product	2014-11-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022249-002	8609863*PED	2026-07-12		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022249-002	8791270*PED	2026-07-12		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022249-002	8895756*PED	2026-07-12		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022249-002	8445524	2029-03-26	U-1402	Drug substance, Drug product	2013-06-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022249-002	8669279	2029-03-26	U-1402	Drug product	2014-10-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022249-002	8883836	2029-03-26	U-1402	Drug product	2014-11-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022249-002	9533955	2029-03-26	U-1952	Drug product	2017-01-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022249-002	9533955	2029-03-26	U-1949	Drug product	2017-01-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022249-002	8445524*PED	2029-09-26		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022249-002	8669279*PED	2029-09-26		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022249-002	8883836*PED	2029-09-26		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022249-002	9533955*PED	2029-09-26		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022249-002	8436190	2030-10-26		Drug product	2013-06-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022249-002	8436190*PED	2031-04-26		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022249-003	8791270	2026-01-12	U-1542	Drug product	2014-12-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022249-003	8791270*PED	2026-07-12		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022249-003	8445524	2029-03-26		Drug substance	2013-09-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022249-003	8344006	2029-09-23	U-1402	Drug product		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022249-003	8445524*PED	2029-09-26		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022249-003	8344006*PED	2030-03-23		Pediatric extension		`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	N022249-001	ODE*	2022-12-07	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	N022249-002	ODE*	2022-12-07	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	N022249-003	ODE*	2022-12-07	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	N022249-004	ODE*	2022-12-07	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N022249-001	ODE*	2022-12-07	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N022249-002	ODE*	2022-12-07	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N022249-003	ODE*	2022-12-07	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N022249-004	ODE*	2022-12-07	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N022249-001	ODE*	2022-12-07	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	N022249-002	ODE*	2022-12-07	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	N022249-003	ODE*	2022-12-07	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	N022249-004	ODE*	2022-12-07	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N022249-001	ODE*	2022-12-07	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	N022249-002	ODE*	2022-12-07	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	N022249-003	ODE*	2022-12-07	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	N022249-004	ODE*	2022-12-07	`e64feba35796…`

Additional Listing Data#

Finished product: Yes
Brand name base: TREANDA
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
BENDAMUSTINE HYDROCHLORIDE	100 mg/20mL

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 · 8 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1805001	Internal RxNorm lookup
1805004	Internal RxNorm lookup
1805007	Internal RxNorm lookup
1805009	Internal RxNorm lookup
1805011	Internal RxNorm lookup
1805012	Internal RxNorm lookup
1805015	Internal RxNorm lookup
1805016	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
39d53698-57fa-7c99-fc5b-f52a55684826	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
d8a9046a-cb9e-4038-9878-7314b52d6527	Product name	1	20230919
dd915fc1-21b5-4853-a27d-6a309d663ab6	Product name	1	20230913
188c28c4-6cdd-493c-850f-0529f5e5dd03	Product name	1	20230912
a62a50ac-1535-4461-9768-8ae703e2e9fb	Product name	1	20210525
c9aaa656-9de9-4780-9592-b48e28af9e6e	Product name	1	20180723
c2696876-93f7-42b5-907d-853b57a286f7	Product name	5	20180626
7dce4968-39c1-46ed-87ca-cce62b5b5728	Product name	1	20151215
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877	Product name	1	20140508
bc07ef78-e82d-0c19-31f4-31f263780582	Product name	1	20140508

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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63459-391-20	EA - Each	63459-391	ae9652c3-0f12-440e-9b77-4035ea016e57	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
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

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
TREANDA	BENDAMUSTINE HYDROCHLORIDE	Cephalon, LLC	39d53698-57fa-7c99-fc5b-f52a55684826	2022-10-27	Warnings, Adverse reactions	Exact identifier application applno (NDA): 022249 application number: NDA022249 ndc (product): 63459-391

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
981Y8SX18M	BENDAMUSTINE HYDROCHLORIDE	3543-75-7	BENDAMUSTINE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1805001	bendamustine HCl 100 MG Injection	PSN	39d53698-57fa-7c99-fc5b-f52a55684826	26
1805011	bendamustine HCl 180 MG in 2 ML Injection	PSN	39d53698-57fa-7c99-fc5b-f52a55684826	26
1805007	bendamustine HCl 25 MG Injection	PSN	39d53698-57fa-7c99-fc5b-f52a55684826	26
1805015	bendamustine HCl 45 MG in 0.5 ML Injection	PSN	39d53698-57fa-7c99-fc5b-f52a55684826	26
1805004	TREANDA 100 MG Injection	PSN	39d53698-57fa-7c99-fc5b-f52a55684826	26
1805012	Treanda 180 MG in 2 ML Injection	PSN	39d53698-57fa-7c99-fc5b-f52a55684826	26
1805009	TREANDA 25 MG Injection	PSN	39d53698-57fa-7c99-fc5b-f52a55684826	26
1805016	Treanda 45 MG in 0.5 ML Injection	PSN	39d53698-57fa-7c99-fc5b-f52a55684826	26
1805016	0.5 ML bendamustine hydrochloride 90 MG/ML Injection [Treanda]	SBD	39d53698-57fa-7c99-fc5b-f52a55684826	26
1805012	2 ML bendamustine hydrochloride 90 MG/ML Injection [Treanda]	SBD	39d53698-57fa-7c99-fc5b-f52a55684826	26
1805004	bendamustine hydrochloride 100 MG Injection [Treanda]	SBD	39d53698-57fa-7c99-fc5b-f52a55684826	26
1805009	bendamustine hydrochloride 25 MG Injection [Treanda]	SBD	39d53698-57fa-7c99-fc5b-f52a55684826	26
1805015	0.5 ML bendamustine hydrochloride 90 MG/ML Injection	SCD	39d53698-57fa-7c99-fc5b-f52a55684826	26
1805011	2 ML bendamustine hydrochloride 90 MG/ML Injection	SCD	39d53698-57fa-7c99-fc5b-f52a55684826	26
1805001	bendamustine hydrochloride 100 MG Injection	SCD	39d53698-57fa-7c99-fc5b-f52a55684826	26
1805007	bendamustine hydrochloride 25 MG Injection	SCD	39d53698-57fa-7c99-fc5b-f52a55684826	26
1805011	bendamustine hydrochloride 180 MG per 2 ML Injection	SY	39d53698-57fa-7c99-fc5b-f52a55684826	26
1805015	bendamustine hydrochloride 45 MG per 0.5 ML Injection	SY	39d53698-57fa-7c99-fc5b-f52a55684826	26
1805004	Treanda 100 MG Injection	SY	39d53698-57fa-7c99-fc5b-f52a55684826	26
1805012	Treanda 180 MG per 2 ML Injection	SY	39d53698-57fa-7c99-fc5b-f52a55684826	26
1805009	Treanda 25 MG Injection	SY	39d53698-57fa-7c99-fc5b-f52a55684826	26
1805016	Treanda 45 MG per 0.5 ML Injection	SY	39d53698-57fa-7c99-fc5b-f52a55684826	26

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