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NDC 49315-0008-03 DOXORUBICIN HYDROCHLORIDE 2 mg/mL Details
DOXORUBICIN HYDROCHLORIDE 2 mg/mL
DOXORUBICIN HYDROCHLORIDE is a INTRAVENOUS INJECTABLE, LIPOSOMAL in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Zydus Lifesciences Limited. The primary component is DOXORUBICIN HYDROCHLORIDE.
MedlinePlus Drug Summary
Doxorubicin is used in combination with other medications to treat certain types of bladder, breast, lung, stomach, and ovarian cancer; Hodgkin's lymphoma (Hodgkin's disease) and non-Hodgkin's lymphoma (cancer that begins in the cells of the immune system); and certain types of leukemia (cancer of the white blood cells), including acute lymphoblastic leukemia (ALL) and acute myeloid leukemia (AML, ANLL). Doxorubicin is also used alone and in combination with other medications to treat certain types of thyroid cancer and certain types of soft tissue or bone sarcomas (cancer that forms in muscles and bones). It is also used to treat neuroblastoma (a cancer that begins in nerve cells and occurs mainly in children) and Wilms' tumor (a type of kidney cancer that occurs in children). Doxorubicin is in a class of medications called anthracyclines. It works by slowing or stopping the growth of cancer cells in your body.
Related Packages: 49315-0008-03Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Doxorubicin
Product Information
| NDC | 49315-0008 |
|---|---|
| Product ID | 49315-008_2c0f5abf-ca66-445c-9a35-e39b2111911e |
| Associated GPIs | |
| GCN Sequence Number | n/a |
| GCN Sequence Number Description | n/a |
| HIC3 | n/a |
| HIC3 Description | n/a |
| GCN | n/a |
| HICL Sequence Number | n/a |
| HICL Sequence Number Description | n/a |
| Brand/Generic | n/a |
| Proprietary Name | DOXORUBICIN HYDROCHLORIDE |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | doxorubicin hydrochloride |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | INJECTABLE, LIPOSOMAL |
| Route | INTRAVENOUS |
| Active Ingredient Strength | 2 |
| Active Ingredient Units | mg/mL |
| Substance Name | DOXORUBICIN HYDROCHLORIDE |
| Labeler Name | Zydus Lifesciences Limited |
| Pharmaceutical Class | Anthracycline Topoisomerase Inhibitor [EPC], Anthracyclines [CS], Topoisomerase Inhibitors [MoA] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA212299 |
| Listing Certified Through | 2024-12-31 |
Package
Package Images
NDC 49315-0008-03 (49315000803)
| NDC Package Code | 49315-008-03 |
|---|---|
| Billing NDC | 49315000803 |
| Package | 1 VIAL, SINGLE-DOSE in 1 CARTON (49315-008-03) / 10 mL in 1 VIAL, SINGLE-DOSE |
| Marketing Start Date | 2020-09-14 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL bad467d4-7e27-4eda-b4d3-854460f0adab Details
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
NDC 49315-008-03
DOXOrubicin Hydrochloride Liposome Injection
20 mg/10 mL
(2 mg/mL)
Cytotoxic Agent Must be diluted
LIPOSOMAL FORMULATION – DO NOT SUBSTITUTE FOR DOXORUBICIN HCL
FOR INTRAVENOUS INFUSION ONLY
10 mL Single-Dose Vial
Rx only
NDC 49315-008-03
DOXOrubicin Hydrochloride Liposome Injection
20 mg/10 mL
(2 mg/mL)
Cytotoxic Agent Must be diluted
LIPOSOMAL FORMULATION – DO NOT SUBSTITUTE FOR DOXORUBICIN HCL
FOR INTRAVENOUS INFUSION ONLY
Sterile
Refrigerate at 2⁰ to 8℃ (36⁰ to 46℉)
Do not freeze
10 mL Single-Dose Vial
Rx only
NDC 49315-009-07
DOXOrubicin Hydrochloride Liposome Injection
50 mg/25 mL
(2 mg/mL)
Cytotoxic Agent Must be diluted
LIPOSOMAL FORMULATION – DO NOT SUBSTITUTE FOR DOXORUBICIN HCL
FOR INTRAVENOUS INFUSION ONLY
25 mL Single-Dose Vial
Rx only
NDC 49315-009-07
DOXOrubicin Hydrochloride Liposome Injection
50 mg/25 mL
(2 mg/mL)
Cytotoxic Agent Must be diluted
LIPOSOMAL FORMULATION – DO NOT SUBSTITUTE FOR DOXORUBICIN HCL
FOR INTRAVENOUS INFUSION ONLY
Sterile
Refrigerate at 2⁰ to 8℃ (36⁰ to 46℉)
Do not freeze
25 mL Single-Dose Vial
Rx only
INGREDIENTS AND APPEARANCE
| DOXORUBICIN HYDROCHLORIDE
doxorubicin hydrochloride injectable, liposomal |
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| DOXORUBICIN HYDROCHLORIDE
doxorubicin hydrochloride injectable, liposomal |
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| Labeler - Zydus Lifesciences Limited (650348852) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| Zydus Lifesciences Limited | 650348852 | ANALYSIS(49315-008, 49315-009) , MANUFACTURE(49315-008, 49315-009) | |