bendamustine hydrochloride

Product NDC
16729-250
11-digit product format
167290250
Labeler code
16729
Product ID
16729-250_1d8759d2-4d4d-78ee-e063-6294a90a53ae
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
bendamustine hydrochloride
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Accord Healthcare, Inc.
Application
ANDA205574
Marketing category
ANDA
Marketing start
2022-12-07
Substance
BENDAMUSTINE HYDROCHLORIDE
Active strength
25 mg/5mL
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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A205574-001BENDAMUSTINE HYDROCHLORIDEBENDAMUSTINE HYDROCHLORIDE25MG/VIALPOWDER / INTRAVENOUSAP2022-12-07
A205574-002BENDAMUSTINE HYDROCHLORIDEBENDAMUSTINE HYDROCHLORIDE100MG/VIALPOWDER / INTRAVENOUSAP2022-12-07

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A205574-001AP
A205574-002AP

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 · 48 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A205574-001BENDAMUSTINE HYDROCHLORIDE25MG/VIALPOWDER / INTRAVENOUSAP2022-12-07011fe1cb6892…
2026-02-19 14:30 UTC2026-02A205574-002BENDAMUSTINE HYDROCHLORIDE100MG/VIALPOWDER / INTRAVENOUSAP2022-12-07011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205574-001BENDAMUSTINE HYDROCHLORIDE25MG/VIALPOWDER / INTRAVENOUSAP2022-12-0731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205574-002BENDAMUSTINE HYDROCHLORIDE100MG/VIALPOWDER / INTRAVENOUSAP2022-12-0731067a03dcf5…
2025-08-23 18:47 UTC2025-08A205574-001BENDAMUSTINE HYDROCHLORIDE25MG/VIALPOWDER / INTRAVENOUSAP2022-12-076a471c1ec25d…
2025-08-23 18:47 UTC2025-08A205574-002BENDAMUSTINE HYDROCHLORIDE100MG/VIALPOWDER / INTRAVENOUSAP2022-12-076a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205574-001BENDAMUSTINE HYDROCHLORIDE25MG/VIALPOWDER / INTRAVENOUSAP2022-12-07fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205574-002BENDAMUSTINE HYDROCHLORIDE100MG/VIALPOWDER / INTRAVENOUSAP2022-12-07fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205574-001BENDAMUSTINE HYDROCHLORIDE25MG/VIALPOWDER / INTRAVENOUSAP2022-12-07b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205574-002BENDAMUSTINE HYDROCHLORIDE100MG/VIALPOWDER / INTRAVENOUSAP2022-12-07b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205574-001BENDAMUSTINE HYDROCHLORIDE25MG/VIALPOWDER / INTRAVENOUSAP2022-12-0703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205574-002BENDAMUSTINE HYDROCHLORIDE100MG/VIALPOWDER / INTRAVENOUSAP2022-12-0703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205574-001BENDAMUSTINE HYDROCHLORIDE25MG/VIALPOWDER / INTRAVENOUSAP2022-12-072680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205574-002BENDAMUSTINE HYDROCHLORIDE100MG/VIALPOWDER / INTRAVENOUSAP2022-12-072680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A205574-001BENDAMUSTINE HYDROCHLORIDE25MG/VIALPOWDER / IV (INFUSION)AP2022-12-075bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A205574-002BENDAMUSTINE HYDROCHLORIDE100MG/VIALPOWDER / IV (INFUSION)AP2022-12-075bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A205574-001BENDAMUSTINE HYDROCHLORIDE25MG/VIALPOWDER / INTRAVENOUSAP2022-12-07d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A205574-002BENDAMUSTINE HYDROCHLORIDE100MG/VIALPOWDER / INTRAVENOUSAP2022-12-07d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A205574-001BENDAMUSTINE HYDROCHLORIDE25MG/VIALPOWDER / IV (INFUSION)AP2022-12-07d06236e962d9…
2024-10-29 15:01 UTC2024-10A205574-002BENDAMUSTINE HYDROCHLORIDE100MG/VIALPOWDER / IV (INFUSION)AP2022-12-07d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A205574-001BENDAMUSTINE HYDROCHLORIDE25MG/VIALPOWDER / IV (INFUSION)AP2022-12-0779d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A205574-002BENDAMUSTINE HYDROCHLORIDE100MG/VIALPOWDER / IV (INFUSION)AP2022-12-0779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A205574-001BENDAMUSTINE HYDROCHLORIDE25MG/VIALPOWDER / IV (INFUSION)AP2022-12-07301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A205574-002BENDAMUSTINE HYDROCHLORIDE100MG/VIALPOWDER / IV (INFUSION)AP2022-12-07301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A205574-001BENDAMUSTINE HYDROCHLORIDE25MG/VIALPOWDER / IV (INFUSION)AP2022-12-071e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A205574-002BENDAMUSTINE HYDROCHLORIDE100MG/VIALPOWDER / IV (INFUSION)AP2022-12-071e350fbaab3a…
2024-05-31 18:47 UTC2024-05A205574-001BENDAMUSTINE HYDROCHLORIDE25MG/VIALPOWDER / IV (INFUSION)AP2022-12-078072bd15b7f6…
2024-05-31 18:47 UTC2024-05A205574-002BENDAMUSTINE HYDROCHLORIDE100MG/VIALPOWDER / IV (INFUSION)AP2022-12-078072bd15b7f6…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A205574-001BENDAMUSTINE HYDROCHLORIDE25MG/VIALPOWDER / IV (INFUSION)AP2022-12-076a51e52b5d6a…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A205574-002BENDAMUSTINE HYDROCHLORIDE100MG/VIALPOWDER / IV (INFUSION)AP2022-12-076a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A205574-001BENDAMUSTINE HYDROCHLORIDE25MG/VIALPOWDER / IV (INFUSION)AP2022-12-071c564ffb4f44…
2024-02-18 07:12 UTC2024-02A205574-002BENDAMUSTINE HYDROCHLORIDE100MG/VIALPOWDER / IV (INFUSION)AP2022-12-071c564ffb4f44…
2023-12-20 04:57 UTC2023-12A205574-001BENDAMUSTINE HYDROCHLORIDE25MG/VIALPOWDER / IV (INFUSION)AP2022-12-07ea1830bbd6c7…
2023-12-20 04:57 UTC2023-12A205574-002BENDAMUSTINE HYDROCHLORIDE100MG/VIALPOWDER / IV (INFUSION)AP2022-12-07ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A205574-001BENDAMUSTINE HYDROCHLORIDE25MG/VIALPOWDER / IV (INFUSION)AP2022-12-07a72a2bbeb626…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A205574-002BENDAMUSTINE HYDROCHLORIDE100MG/VIALPOWDER / IV (INFUSION)AP2022-12-07a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A205574-001BENDAMUSTINE HYDROCHLORIDE25MG/VIALPOWDER / IV (INFUSION)AP2022-12-079b2671bbb829…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A205574-002BENDAMUSTINE HYDROCHLORIDE100MG/VIALPOWDER / IV (INFUSION)AP2022-12-079b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A205574-001BENDAMUSTINE HYDROCHLORIDE25MG/VIALPOWDER / IV (INFUSION)AP2022-12-07a67488948f0b…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A205574-002BENDAMUSTINE HYDROCHLORIDE100MG/VIALPOWDER / IV (INFUSION)AP2022-12-07a67488948f0b…

Observed Orange Book normalized TE history#

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

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A205574-001AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A205574-002AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205574-001AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205574-002AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08A205574-001AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A205574-002AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205574-001AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205574-002AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205574-001AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205574-002AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205574-001AP103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205574-002AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205574-001AP12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205574-002AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A205574-001AP15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A205574-002AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A205574-001AP1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A205574-002AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A205574-001AP1d06236e962d9…
2024-10-29 15:01 UTC2024-10A205574-002AP1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A205574-001AP179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A205574-002AP179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A205574-001AP1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A205574-002AP1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A205574-001AP11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A205574-002AP11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A205574-001AP18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A205574-002AP18072bd15b7f6…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A205574-001AP16a51e52b5d6a…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A205574-002AP16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A205574-001AP11c564ffb4f44…
2024-02-18 07:12 UTC2024-02A205574-002AP11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A205574-001AP1ea1830bbd6c7…
2023-12-20 04:57 UTC2023-12A205574-002AP1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A205574-001AP1a72a2bbeb626…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A205574-002AP1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A205574-001AP19b2671bbb829…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A205574-002AP19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A205574-001AP1a67488948f0b…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A205574-002AP1a67488948f0b…

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2023-12-20 04:57 UTC2023-12A205574-001PC2023-06-05ea1830bbd6c7…
2023-12-20 04:57 UTC2023-12A205574-002PC2023-06-05ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A205574-001PC2023-06-05a72a2bbeb626…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A205574-002PC2023-06-05a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A205574-001PC2023-06-059b2671bbb829…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A205574-002PC2023-06-059b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A205574-001PC2023-06-05a67488948f0b…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A205574-002PC2023-06-05a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A205574-001PC2023-06-053f0d92c62455…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A205574-002PC2023-06-053f0d92c62455…
2023-05-13 08:27 UTC2023-05A205574-001PC2023-06-05053a50430f4f…
2023-05-13 08:27 UTC2023-05A205574-002PC2023-06-05053a50430f4f…
2023-01-26 05:58 UTC2023-01A205574-001PC2023-06-053bdfa0b2c4d7…
2023-01-26 05:58 UTC2023-01A205574-002PC2023-06-053bdfa0b2c4d7…

Additional Listing Data#

Finished product
Yes
Brand name base
bendamustine hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BENDAMUSTINE HYDROCHLORIDE25 mg/5mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
981Y8SX18MInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1805001Internal RxNorm lookup
1805007Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
33867f0f-f317-1fd0-e054-00144ff8d46cAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d8a9046a-cb9e-4038-9878-7314b52d6527Product name120230919
dd915fc1-21b5-4853-a27d-6a309d663ab6Product name120230913
188c28c4-6cdd-493c-850f-0529f5e5dd03Product name120230912
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
c9aaa656-9de9-4780-9592-b48e28af9e6eProduct name120180723
c2696876-93f7-42b5-907d-853b57a286f7Product name520180626
7dce4968-39c1-46ed-87ca-cce62b5b5728Product name120151215
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
16729-250-03bendamustine hydrochloride5 mL in 1 VIAL, SINGLE-DOSEINJECTION, POWDER, LYOPHILIZED,56
16729-250-03bendamustine hydrochloride1 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16729-250-03EA - Each16729-250312eba0e-b64c-4949-bfc1-2904d35be13312023-01-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16729-250BENDAMUSTINE HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [ACCORD HEALTHCARE, INC.]6Current NDC, Legacy NDC, 2 package rows20240719_33867f0f-f317-1fd0-e054-00144ff8d46c.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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
bendamustine hydrochlorideBENDAMUSTINE HYDROCHLORIDEAccord Healthcare, Inc.33867f0f-f317-1fd0-e054-00144ff8d46c2024-07-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205574
application number: ANDA205574
ndc (product): 16729-250
bendamustine hydrochlorideBENDAMUSTINE HYDROCHLORIDEBluePoint Laboratories0df025d2-c093-427a-b599-f605e71fe8352024-03-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205574
application number: ANDA205574

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1805001bendamustine HCl 100 MG InjectionPSN33867f0f-f317-1fd0-e054-00144ff8d46c6
1805007bendamustine HCl 25 MG InjectionPSN33867f0f-f317-1fd0-e054-00144ff8d46c6
1805001bendamustine hydrochloride 100 MG InjectionSCD33867f0f-f317-1fd0-e054-00144ff8d46c6
1805007bendamustine hydrochloride 25 MG InjectionSCD33867f0f-f317-1fd0-e054-00144ff8d46c6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
16729-250-03167290250031 VIAL, SINGLE-DOSE in 1 CARTON (16729-250-03) / 5 mL in 1 VIAL, SINGLE-DOSE2022-12-070000-00-00NoNoCurrent