bendamustine hydrochloride 25 MG Injection
- RxCUI
- 1805007
- RxNorm name
- bendamustine hydrochloride 25 MG Injection
- Display name
- Bendamustine (Injectable)
- Full name
- bendamustine hydrochloride 25 MG Injection
- Term type
- SCD
- Status
- Active
- Strength
- 25 mg
- Dose form
- Injection
- Route
- Injectable
- Updated
- 2026-10-24 12:46:49
RxNorm Status History#
- Status
- Active
- Source
- RXNORM
- Current
- YES
- Release start
- 092016
- Active start
- 092016
- Multiple ingredient
- NO
- Branded
- NO
Ingredients And Strength#
| Ingredient | Strength | Base | Basis of strength |
|---|---|---|---|
| bendamustine hydrochloride | 25 MG / 1 EACH | bendamustine | bendamustine hydrochloride |
Dose Form Concepts#
| Dose form | RxCUI |
|---|---|
| Injection | 1649574 |
Derived Ingredient Concepts#
| Ingredient | RxCUI |
|---|---|
| bendamustine | 134547 |
Source Vocabulary Codes#
| Code type | Values | Count | Category |
|---|---|---|---|
| PRESCRIBABLE | Y | 1 | ATTRIBUTES |
| RXNAV_STR | bendamustine hydrochloride 25 MG Injection | 1 | NAMES |
| RxNorm Name | bendamustine hydrochloride 25 MG Injection | 1 | NAMES |
| TTY | SCD | 1 | ATTRIBUTES |
| SPL_SET_ID | 3 | CODES | |
| RxCUI | 1805007 | 1 | CODES |
| MMSL_CODE | 2 | CODES |
FDA NDC Products And Packages#
| Package NDC | Product NDC | Name | Labeler | Application |
|---|---|---|---|---|
| 16729-250-03 | 16729-250 | bendamustine hydrochloride bendamustine hydrochloride | Accord Healthcare, Inc. | ANDA205574 |
| 55150-391-01 | 55150-391 | BENDAMUSTINE HYDROCHLORIDE BENDAMUSTINE HYDROCHLORIDE | Eugia US LLC | ANDA214739 |
| 71288-102-10 | 71288-102 | Bendamustine bendamustine HCl | Meitheal Pharmaceuticals Inc. | ANDA211001 |
Drugs@FDA Applications#
| Application | NDC | Name | Marketing category | Labeler |
|---|---|---|---|---|
| ANDA205574 | 16729-250 | bendamustine hydrochloride bendamustine hydrochloride | ANDA | Accord Healthcare, Inc. |
| ANDA214739 | 55150-391 | BENDAMUSTINE HYDROCHLORIDE BENDAMUSTINE HYDROCHLORIDE | ANDA | Eugia US LLC |
| ANDA211001 | 71288-102 | Bendamustine bendamustine HCl | ANDA | Meitheal Pharmaceuticals Inc. |
UNII Substances#
No records found.
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.
| 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 | 71288-102-10 71288-102 71288010210 1805007 |
| bendamustine hydrochloride | BENDAMUSTINE HYDROCHLORIDE | Accord Healthcare, Inc. | 33867f0f-f317-1fd0-e054-00144ff8d46c | 2024-07-18 | Warnings, Adverse reactions | 16729-250-03 16729-250 16729025003 1805007 |
| bendamustine hydrochloride | BENDAMUSTINE HYDROCHLORIDE | BluePoint Laboratories | 0df025d2-c093-427a-b599-f605e71fe835 | 2024-03-29 | Warnings, Adverse reactions | 68001057141 1805007 |
| BENDAMUSTINE HYDROCHLORIDE | BENDAMUSTINE HYDROCHLORIDE | Eugia US LLC | dbe34bc1-06b2-493f-8859-e8b143357aa8 | 2023-07-05 | Warnings, Adverse reactions | 55150-391-01 55150-391 55150039101 1805007 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed RxNorm Mappings#
| Set ID | RxNorm mappings | Terms | SPL version | Label | Effective |
|---|---|---|---|---|---|
| 39d53698-57fa-7c99-fc5b-f52a55684826 | bendamustine HCl 25 MG Injection [PSN] · bendamustine hydrochloride 25 MG Injection [SCD] | 2 | 26 | These highlights do not include all the information needed to use TREANDA safely and effectively. See full prescribing information for TREANDA. TREANDA ® (bendamustine hydrochloride) injection, for intravenous use TREANDA ® (bendamustine hydrochloride) for injection, for intravenous use Initial U.S. Approval: 2008 | 20221027 |
| 40f6f58d-d9ac-4f65-9fc7-16984bf1f180 | bendamustine HCl 25 MG Injection [PSN] · bendamustine hydrochloride 25 MG Injection [SCD] | 2 | 10 | These highlights do not include all the information needed to use BENDAMUSTINE HYDROCHLORIDE FOR INJECTION safely and effectively. See full prescribing information for BENDAMUSTINE HYDROCHLORIDE FOR INJECTION. BENDAMUSTINE HYDROCHLORIDE for injection, for intravenous use Initial U.S. Approval: 2008 | 20260511 |
| 33867f0f-f317-1fd0-e054-00144ff8d46c | bendamustine HCl 25 MG Injection [PSN] · bendamustine hydrochloride 25 MG Injection [SCD] | 2 | 6 | These highlights do not include all the information needed to use BENDAMUSTINE HYDROCHLORIDE FOR INJECTION safely and effectively. See full prescribing information for BENDAMUSTINE HYDROCHLORIDE FOR INJECTION. BENDAMUSTINE HYDROCHLORIDE for Injection, for intravenous use Initial U.S. Approval: 2008 | 20240718 |
| 0df025d2-c093-427a-b599-f605e71fe835 | bendamustine HCl 25 MG Injection [PSN] · bendamustine hydrochloride 25 MG Injection [SCD] | 2 | 3 | These highlights do not include all the information needed to use BENDAMUSTINE HYDROCHLORIDE FOR INJECTION safely and effectively. See full prescribing information for BENDAMUSTINE HYDROCHLORIDE FOR INJECTION. BENDAMUSTINE HYDROCHLORIDE for Injection, for intravenous use Initial U.S. Approval: 2008 | 20240329 |
| dbe34bc1-06b2-493f-8859-e8b143357aa8 | bendamustine HCl 25 MG Injection [PSN] · bendamustine hydrochloride 25 MG Injection [SCD] | 2 | 2 | These highlights do not include all the information needed to use BENDAMUSTINE HYDROCHLORIDE FOR INJECTION safely and effectively. See full prescribing information for BENDAMUSTINE HYDROCHLORIDE FOR INJECTION. BENDAMUSTINE HYDROCHLORIDE for injection, for intravenous use Initial U.S. Approval: 2008 | 20230705 |
Recently Linked DailyMed Labels#
| Set ID | Title | Manufacturer | Effective |
|---|---|---|---|
| 40f6f58d-d9ac-4f65-9fc7-16984bf1f180 | These highlights do not include all the information needed to use BENDAMUSTINE HYDROCHLORIDE FOR INJECTION safely and effectively. See full prescribing information for BENDAMUSTINE HYDROCHLORIDE FOR INJECTION. BENDAMUSTINE HYDROCHLORIDE for injection, for intravenous use Initial U.S. Approval: 2008 | Meitheal Pharmaceuticals Inc. | 20260511 |
| 5de3a3b3-7acd-7f0b-ecc4-60d544484149 | These highlights do not include all the information needed to use BENDAMUSTINE HYDROCHLORIDE FOR INJECTION safely and effectively. See full prescribing information for BENDAMUSTINE HYDROCHLORIDE FOR INJECTION. BENDAMUSTINE HYDROCHLORIDE for injection, for intravenous use Initial U.S. Approval: 2008 | Apotex Corp | Apotex Inc | Gland Pharma Limited | 20241113 |
| 33867f0f-f317-1fd0-e054-00144ff8d46c | These highlights do not include all the information needed to use BENDAMUSTINE HYDROCHLORIDE FOR INJECTION safely and effectively. See full prescribing information for BENDAMUSTINE HYDROCHLORIDE FOR INJECTION. BENDAMUSTINE HYDROCHLORIDE for Injection, for intravenous use Initial U.S. Approval: 2008 | Accord Healthcare, Inc. | Intas Pharmaceuticals Limited | 20240718 |
| 0df025d2-c093-427a-b599-f605e71fe835 | These highlights do not include all the information needed to use BENDAMUSTINE HYDROCHLORIDE FOR INJECTION safely and effectively. See full prescribing information for BENDAMUSTINE HYDROCHLORIDE FOR INJECTION. BENDAMUSTINE HYDROCHLORIDE for Injection, for intravenous use Initial U.S. Approval: 2008 | BluePoint Laboratories | Intas Pharmaceuticals Limited | 20240329 |
| dbe34bc1-06b2-493f-8859-e8b143357aa8 | These highlights do not include all the information needed to use BENDAMUSTINE HYDROCHLORIDE FOR INJECTION safely and effectively. See full prescribing information for BENDAMUSTINE HYDROCHLORIDE FOR INJECTION. BENDAMUSTINE HYDROCHLORIDE for injection, for intravenous use Initial U.S. Approval: 2008 | Eugia US LLC | EUGIA Pharma Specialities Limited | 20230705 |
Drug Classes#
| Source | Class ID | Class | Type | Relationship | Drug concept |
|---|---|---|---|---|---|
| ATC | L01AA | Nitrogen mustard analogues | ATC1-4 | bendamustine | |
| FDASPL | N0000175558 | Alkylating Drug | EPC | has_epc | bendamustine |
| FDASPL | N0000000236 | Alkylating Activity | MOA | has_moa | bendamustine |
| MEDRT | D000069461 | Bendamustine Hydrochloride | CHEM | has_ingredient | bendamustine hydrochloride |
| MEDRT | D000069461 | Bendamustine Hydrochloride | CHEM | has_ingredient | bendamustine |
| MEDRT | D004342 | Drug Hypersensitivity | DISEASE | ci_with | bendamustine hydrochloride |
| MEDRT | D004342 | Drug Hypersensitivity | DISEASE | ci_with | bendamustine |
| MEDRT | D007945 | Leukemia, Lymphoid | DISEASE | may_treat | bendamustine hydrochloride |
| MEDRT | D007945 | Leukemia, Lymphoid | DISEASE | may_treat | bendamustine |
| MEDRT | D008228 | Lymphoma, Non-Hodgkin | DISEASE | may_treat | bendamustine hydrochloride |
| MEDRT | D008228 | Lymphoma, Non-Hodgkin | DISEASE | may_treat | bendamustine |
| MEDRT | N0000000236 | Alkylating Activity | MOA | has_moa | bendamustine hydrochloride |
| MEDRT | N0000000236 | Alkylating Activity | MOA | has_moa | bendamustine |
Properties#
| Category | Property | Value |
|---|---|---|
| ATTRIBUTES | AVAILABLE_STRENGTH | 25 MG (expressed as bendamustine hydrochloride) |
| ATTRIBUTES | GENERAL_CARDINALITY | SINGLE |
| ATTRIBUTES | HUMAN_DRUG | US |
| ATTRIBUTES | RXNAV_HUMAN_DRUG | US |
| ATTRIBUTES | SCHEDULE | 0 |
| CODES | ANDA | ANDA205574 |
| CODES | ANDA | ANDA211001 |
| CODES | ANDA | ANDA214739 |
| CODES | SNOMEDCT | 1201802008 |
| CODES | VUID | 4029791 |
| NAMES | Prescribable Synonym | bendamustine HCl 25 MG Injection |
| SOURCES | Source | Gold Standard Alchemy |
| SOURCES | Source | Metathesaurus FDA Structured Product Labels |
| SOURCES | Source | Micromedex RED BOOK |
| SOURCES | Source | Multum MediSource Lexicon |
| SOURCES | Source | National Drug Data File Plus Source Vocabulary |
| SOURCES | Source | US Edition of SNOMED_CT |
| SOURCES | Source | Veterans Health Administration National Drug File |