Bendamustine

Product NDC: 71288-103
11-digit product format: 712880103
Labeler code: 71288
Product ID: 71288-103_c4d02b46-b7dc-4c54-9f17-49f378437808
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Bendamustine HCl
Dosage form: INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route: INTRAVENOUS
Labeler: Meitheal Pharmaceuticals Inc.
Application: ANDA211001
Marketing category: ANDA
Marketing start: 2023-06-05
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 42.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A211001-001	BENDAMUSTINE HYDROCHLORIDE	BENDAMUSTINE HYDROCHLORIDE	25MG/VIAL	POWDER / INTRAVENOUS	AP		2023-06-05
A211001-002	BENDAMUSTINE HYDROCHLORIDE	BENDAMUSTINE HYDROCHLORIDE	100MG/VIAL	POWDER / INTRAVENOUS	AP		2023-06-05

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A211001-001	AP
A211001-002	AP

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 · 46 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A211001-001	BENDAMUSTINE HYDROCHLORIDE	25MG/VIAL	POWDER / INTRAVENOUS	AP	2023-06-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211001-002	BENDAMUSTINE HYDROCHLORIDE	100MG/VIAL	POWDER / INTRAVENOUS	AP	2023-06-05	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A211001-001	BENDAMUSTINE HYDROCHLORIDE	25MG/VIAL	POWDER / INTRAVENOUS	AP	2023-06-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211001-002	BENDAMUSTINE HYDROCHLORIDE	100MG/VIAL	POWDER / INTRAVENOUS	AP	2023-06-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211001-001	BENDAMUSTINE HYDROCHLORIDE	25MG/VIAL	POWDER / INTRAVENOUS	AP	2023-06-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211001-002	BENDAMUSTINE HYDROCHLORIDE	100MG/VIAL	POWDER / INTRAVENOUS	AP	2023-06-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211001-001	BENDAMUSTINE HYDROCHLORIDE	25MG/VIAL	POWDER / INTRAVENOUS	AP	2023-06-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211001-002	BENDAMUSTINE HYDROCHLORIDE	100MG/VIAL	POWDER / INTRAVENOUS	AP	2023-06-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211001-001	BENDAMUSTINE HYDROCHLORIDE	25MG/VIAL	POWDER / INTRAVENOUS	AP	2023-06-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211001-002	BENDAMUSTINE HYDROCHLORIDE	100MG/VIAL	POWDER / INTRAVENOUS	AP	2023-06-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211001-001	BENDAMUSTINE HYDROCHLORIDE	25MG/VIAL	POWDER / INTRAVENOUS	AP	2023-06-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211001-002	BENDAMUSTINE HYDROCHLORIDE	100MG/VIAL	POWDER / INTRAVENOUS	AP	2023-06-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211001-001	BENDAMUSTINE HYDROCHLORIDE	25MG/VIAL	POWDER / INTRAVENOUS	AP	2023-06-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211001-002	BENDAMUSTINE HYDROCHLORIDE	100MG/VIAL	POWDER / INTRAVENOUS	AP	2023-06-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211001-001	BENDAMUSTINE HYDROCHLORIDE	25MG/VIAL	POWDER / INTRAVENOUS	AP	2023-06-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211001-002	BENDAMUSTINE HYDROCHLORIDE	100MG/VIAL	POWDER / INTRAVENOUS	AP	2023-06-05	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211001-001	BENDAMUSTINE HYDROCHLORIDE	25MG/VIAL	POWDER / IV (INFUSION)	AP	2023-06-05	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211001-002	BENDAMUSTINE HYDROCHLORIDE	100MG/VIAL	POWDER / IV (INFUSION)	AP	2023-06-05	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211001-001	BENDAMUSTINE HYDROCHLORIDE	25MG/VIAL	POWDER / INTRAVENOUS	AP	2023-06-05	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211001-002	BENDAMUSTINE HYDROCHLORIDE	100MG/VIAL	POWDER / INTRAVENOUS	AP	2023-06-05	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211001-001	BENDAMUSTINE HYDROCHLORIDE	25MG/VIAL	POWDER / IV (INFUSION)	AP	2023-06-05	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211001-002	BENDAMUSTINE HYDROCHLORIDE	100MG/VIAL	POWDER / IV (INFUSION)	AP	2023-06-05	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211001-001	BENDAMUSTINE HYDROCHLORIDE	25MG/VIAL	POWDER / IV (INFUSION)	AP	2023-06-05	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211001-002	BENDAMUSTINE HYDROCHLORIDE	100MG/VIAL	POWDER / IV (INFUSION)	AP	2023-06-05	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211001-001	BENDAMUSTINE HYDROCHLORIDE	25MG/VIAL	POWDER / IV (INFUSION)	AP	2023-06-05	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211001-002	BENDAMUSTINE HYDROCHLORIDE	100MG/VIAL	POWDER / IV (INFUSION)	AP	2023-06-05	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211001-001	BENDAMUSTINE HYDROCHLORIDE	25MG/VIAL	POWDER / IV (INFUSION)	AP	2023-06-05	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211001-002	BENDAMUSTINE HYDROCHLORIDE	100MG/VIAL	POWDER / IV (INFUSION)	AP	2023-06-05	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211001-001	BENDAMUSTINE HYDROCHLORIDE	25MG/VIAL	POWDER / IV (INFUSION)	AP	2023-06-05	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A211001-002	BENDAMUSTINE HYDROCHLORIDE	100MG/VIAL	POWDER / IV (INFUSION)	AP	2023-06-05	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A211001-001	BENDAMUSTINE HYDROCHLORIDE	25MG/VIAL	POWDER / IV (INFUSION)	AP	2023-06-05	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A211001-002	BENDAMUSTINE HYDROCHLORIDE	100MG/VIAL	POWDER / IV (INFUSION)	AP	2023-06-05	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A211001-001	BENDAMUSTINE HYDROCHLORIDE	25MG/VIAL	POWDER / IV (INFUSION)	AP	2023-06-05	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A211001-002	BENDAMUSTINE HYDROCHLORIDE	100MG/VIAL	POWDER / IV (INFUSION)	AP	2023-06-05	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A211001-001	BENDAMUSTINE HYDROCHLORIDE	25MG/VIAL	POWDER / IV (INFUSION)	AP	2023-06-05	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A211001-002	BENDAMUSTINE HYDROCHLORIDE	100MG/VIAL	POWDER / IV (INFUSION)	AP	2023-06-05	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A211001-001	BENDAMUSTINE HYDROCHLORIDE	25MG/VIAL	POWDER / IV (INFUSION)	AP	2023-06-05	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A211001-002	BENDAMUSTINE HYDROCHLORIDE	100MG/VIAL	POWDER / IV (INFUSION)	AP	2023-06-05	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A211001-001	BENDAMUSTINE HYDROCHLORIDE	25MG/VIAL	POWDER / IV (INFUSION)	AP	2023-06-05	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A211001-002	BENDAMUSTINE HYDROCHLORIDE	100MG/VIAL	POWDER / IV (INFUSION)	AP	2023-06-05	`9b2671bbb829…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 46 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A211001-001	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211001-002	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A211001-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211001-002	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211001-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211001-002	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211001-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211001-002	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211001-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211001-002	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211001-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211001-002	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211001-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211001-002	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211001-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211001-002	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211001-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211001-002	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211001-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211001-002	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211001-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211001-002	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211001-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211001-002	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211001-001	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211001-002	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211001-001	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211001-002	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211001-001	AP	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A211001-002	AP	1	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A211001-001	AP	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A211001-002	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A211001-001	AP	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A211001-002	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A211001-001	AP	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A211001-002	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A211001-001	AP	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A211001-002	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A211001-001	AP	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A211001-002	AP	1	`9b2671bbb829…`

Additional Listing Data#

Finished product: Yes
Brand name base: Bendamustine
Listing expiration: 2027-12-31

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 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1805001	Internal RxNorm lookup
1805007	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
40f6f58d-d9ac-4f65-9fc7-16984bf1f180	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
71288-103-20	Bendamustine	20 mL in 1 VIAL, SINGLE-DOSE	INJECTION, POWDER, LYOPHILIZED,	20		10
71288-103-20	Bendamustine	1 in 1 CARTON	INJECTION, POWDER, LYOPHILIZED,	1		10

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
71288-103-20	EA - Each	71288-103	b3d4cdbf-38d2-4ec8-8b2e-59ad02593d2f	1	2023-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71288-103	BENDAMUSTINE (BENDAMUSTINE HCL) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION BENDAMUSTINE (BENDAMUSTINE HCL) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MEITHEAL PHARMACEUTICALS INC.]	9	Current NDC, 2 package rows	20230608_40f6f58d-d9ac-4f65-9fc7-16984bf1f180.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
Bendamustine	BENDAMUSTINE HCL	Meitheal Pharmaceuticals Inc.	40f6f58d-d9ac-4f65-9fc7-16984bf1f180	2026-05-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211001 application number: ANDA211001 ndc (product): 71288-103

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	40f6f58d-d9ac-4f65-9fc7-16984bf1f180	10
1805007	bendamustine HCl 25 MG Injection	PSN	40f6f58d-d9ac-4f65-9fc7-16984bf1f180	10
1805001	bendamustine hydrochloride 100 MG Injection	SCD	40f6f58d-d9ac-4f65-9fc7-16984bf1f180	10
1805007	bendamustine hydrochloride 25 MG Injection	SCD	40f6f58d-d9ac-4f65-9fc7-16984bf1f180	10

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
71288-103-20	71288010320	1 VIAL, SINGLE-DOSE in 1 CARTON (71288-103-20) / 20 mL in 1 VIAL, SINGLE-DOSE	2023-06-05	No	No	Current