DOXORUBICIN HYDROCHLORIDE 2 mg/mL Injectable, Liposomal — NDC 49315-009-07 (Billing 49315-0009-07)
This is a package of DOXORUBICIN HYDROCHLORIDE 2 mg/mL Injectable, Liposomal from Zydus Lifesciences Limited, marketed since Sep 2020 and currently FDA-listed. It is this product's only package size.
NDC database record
One package, one record: these facts belong to NDC 49315-009-07 alone.
- Record
- FDA NDC Directory package listing · Human prescription drug
- Code segments
- 49315 labeler · 009 product · 07 package
- Package marketed since
- Sep 14, 2020
- Sample package
- No — commercial package
- Listing certified through
- Dec 31, 2026
- Barcode (UPC-A, from the NDC)
- 3 4931500907 1
- FDA record last changed
- Jul 24, 2026
Other active recalls for Doxorubicin Hydrochloride (different manufacturers) — 1 · tap to view
Identity & classification
Regulatory identifiers FDA, NLM and CMS codes for this package
- RxCUI (RxNorm): 1790115
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 8, 2026
- FDA label on DailyMed · label index refreshed Oct 8, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 8, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 8, 2026
RxNorm drug class
This medicine belongs to the Anthracycline Topoisomerase Inhibitor class.
Where does this data come from?
- RxClass (NLM) · catalog refreshed Oct 8, 2026
Clinical
- It is a chemotherapy medicine for many cancers. Standard forms treat breast cancer, leukemias, lymphomas, and several spread cancers. Liposomal forms like Doxil treat ovarian cance...
- A healthcare professional gives it into a vein in treatment cycles, usually every few weeks. You do not take it by mouth. Your team sets the exact schedule.
- Tiredness, nausea, vomiting, mouth sores, diarrhea or constipation, rash, and low blood counts are common. Liposomal forms can cause hand-foot syndrome. Let your team know about an...
- Call right away for fever or chills, unusual bleeding, shortness of breath, leg swelling, a racing heartbeat, or pain, redness, or swelling where the IV is. Heart problems can also...
Patient education
Supplement & herbal interactions
Doxorubicin may be associated with lower levels of 1 nutrient — worth a chat with your pharmacist, not a cause for alarm.
Where does this data come from?
- MedlinePlus (NLM) · refreshed Oct 8, 2026
- FDA label on DailyMed · label index refreshed Oct 8, 2026
Ask a licensed pharmacist directly — free, answered by our team.
Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per each | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data. | |
| Medicare drug plans payPart D · quarterly | No Part D plan price is available for this NDC in our data. | |
Where does this data come from?
- CMS NADAC weekly file
- CMS ASP pricing files · refreshed Sep 20, 2026
- CMS Medicaid State Drug Utilization Data · refreshed Oct 9, 2026
- CMS Part D plan pricing files · refreshed Sep 24, 2026
- VA National Acquisition Center price file
Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Marketing end | Status |
|---|---|---|---|---|
| 49315-0009-07 You're viewing this Main listing | 1 VIAL, SINGLE-DOSE in 1 CARTON / 25 mL in 1 VIAL, SINGLE-DOSE | 2020-09-14 | — | Active |
Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Doxil 2 mg/mL 00338-0067-01 | Baxter | 1 vial | — | AB | FDA listed | — |
| Doxorubicin Hydrochloride Liposome 2 mg/mL 00338-0086-01 | Baxter | 1 vial | — | AB | FDA listed | — |
| Doxil 2 mg/mL 00338-9665-01 | Baxter | 1 vial | — | AB | FDA listed | — |
| Doxorubicin Hydrochloride 2 mg/mL 16714-0856-01 | NorthStar | 1 vial | — | AB | Discontinued | — |
| Doxorubicin Hydrochloride Liposome 2 mg/mL 25021-0263-10 | Sagent | 1 vial | — | AB | FDA listed | — |
| doxorubicin hydrochloride 2 mg/mL 46708-0525-25 | Alembic | 1 vial | — | AB | FDA listed | — |
| Doxorubicin Hydrochloride 2 mg/mL 47335-0050-40 | Sun | 1 vial | — | AB | FDA listed | — |
| Doxorubicin Hydrochloride 2 mg/mLthis 49315-0009-07 | Zydus | 1 vial | — | AB | FDA listed | — |
| doxorubicin hydrochloride 2 mg/mL 62332-0525-25 | Alembic | 1 vial | — | AB | FDA listed | — |
| Doxorubicin Hydrochloride 2 mg/mL 68001-0345-26 | BluePoint | 1 vial | — | AB | FDA listed | — |
| Doxorubicin Hydrochloride 2 mg/mL 68001-0493-26 | BluePoint | 1 vial | — | AB | FDA listed | — |
| Doxorubicin Hydrochloride 2 mg/mL 68001-0629-26 | BluePoint | 1 vial | — | AB | FDA listed | — |
| Doxorubicin Hydrochloride 2 mg/mL 68001-0704-26 | BluePoint | 1 vial | — | AB | FDA listed | — |
| Doxorubicin Hydrochloride 2 mg/mL 68083-0249-01 | Gland | 1 vial | — | AP | FDA listed | — |
| Doxorubicin Hydrochloride 2 mg/mL 70710-1531-01 | Zydus | 1 vial | — | AB | FDA listed | — |
| Doxorubicin Hydrochloride 2 mg/mL 70748-0340-01 | Lupin | 1 vial | — | AB | FDA listed | — |
| Doxorubicin Hydrochloride 2 mg/mL 72603-0200-01 | NorthStar | 1 vial | — | AB | FDA listed | — |
| doxorubicin hydrochloride 2 mg/mL 75907-0364-01 | Dr. | 1 vial | — | AB | FDA listed | — |
| Doxorubicin Hydrochloride 2 mg/mL 49315-0008-03 | Zydus | 1 vial | — | AB | FDA listed | — |
| DOXOrubicin Hydrochloride 2 mg/mL 62756-0826-40 | Sun | 1 vial | — | AP | FDA listed | — |
| DOXOrubicin Hydrochloride 2 mg/mL 62756-0827-40 | Sun | 1 vial | — | AP | FDA listed | — |
| Doxorubicin Hydrochloride 2 mg/mL 16714-0742-01 | NorthStar | 1 vial | — | AB | Discontinued | — |
| Doxorubicin Hydrochloride 2 mg/mL 00069-0343-02 | Pfizer | 1 vial | — | AP | FDA listed | — |
| Doxorubicin Hydrochloride 2 mg/mL 00143-9085-01 | Hikma | 1 vial | — | AP | FDA listed | — |
| Doxorubicin Hydrochloride 2 mg/mL 63323-0883-05 | Fresenius | 1 vial | — | AP | FDA listed | — |
| Doxorubicin Hydrochloride 2 mg/mL 68001-0492-36 | BluePoint | 1 vial | — | AB | FDA listed | — |
| Doxorubicin Hydrochloride 2 mg/mL 00069-0277-02 | Pfizer | 1 vial | — | AP | FDA listed | — |
| Doxorubicin hydrochloride 2 mg/mL 45963-0733-55 | Actavis | 1 vial | — | AP | FDA listed | — |
| Doxil 2 mg/mL 00338-0063-01 | Baxter | 1 vial | — | AB | FDA listed | — |
| Doxorubicin Hydrochloride 2 mg/mL 68083-0248-01 | Gland | 1 vial | — | AP | FDA listed | — |
| Doxorubicin Hydrochloride 2 mg/mL 00069-1442-04 | Pfizer | 1 vial | — | AP | FDA listed | — |
| Doxorubicin Hydrochloride 2 mg/mL 00069-3358-25 | Pfizer | 1 vial | — | AP | FDA listed | — |
| Doxorubicin Hydrochloride 2 mg/mL 00069-4031-12 | Pfizer | 1 vial | — | AP | FDA listed | — |
| Doxorubicin Hydrochloride 2 mg/mL 00143-9084-01 | Hikma | 1 vial | — | AP | FDA listed | — |
| Doxorubicin Hydrochloride 2 mg/mL 00143-9090-01 | Hikma | 1 vial | — | AP | FDA listed | — |
| doxorubicin hydrochloride 2 mg/mL 62332-0810-10 | Alembic | 1 vial | — | AB | FDA listed | — |
| Doxorubicin Hydrochloride 2 mg/mL 00069-1542-20 | Pfizer | 1 vial | — | AP | FDA listed | — |
| Doxorubicin Hydrochloride 2 mg/mL 47335-0049-40 | Sun | 1 vial | — | AB | FDA listed | — |
| Doxorubicin Hydrochloride 2 mg/mL 68001-0703-36 | BluePoint | 1 vial | — | AB | FDA listed | — |
| Doxorubicin Hydrochloride 2 mg/mL 70121-1219-01 | Amneal | 1 vial | — | AP | FDA listed | — |
| doxorubicin hydrochloride 2 mg/mL 75907-0363-01 | Dr. | 1 vial | — | AB | FDA listed | — |
| Doxorubicin Hydrochloride 2 mg/mL 00069-0358-20 | Pfizer | 1 vial | — | AP | FDA listed | — |
| Doxorubicin Hydrochloride 2 mg/mL 00069-4205-05 | Pfizer | 1 vial | — | AP | FDA listed | — |
| Doxorubicin Hydrochloride 2 mg/mL 00143-9092-01 | Hikma | 1 vial | — | — | FDA listed | — |
| doxorubicin hydrochloride 2 mg/mL 46708-0810-10 | Alembic | 1 vial | — | AB | FDA listed | — |
| Doxorubicin Hydrochloride 2 mg/mL 00069-0255-10 | Pfizer | 1 vial | — | AP | FDA listed | — |
| Doxorubicin Hydrochloride 2 mg/mL 00143-9086-01 | Hikma | 1 vial | — | AP | FDA listed | — |
| Doxorubicin Hydrochloride 2 mg/mL 00143-9087-01 | Hikma | 1 vial | — | AP | FDA listed | — |
| Doxorubicin Hydrochloride 2 mg/mL 72603-0103-01 | NorthStar | 1 vial | — | AB | FDA listed | — |
| Doxorubicin Hydrochloride 2 mg/mL 00143-9091-01 | Hikma | 1 vial | — | AP | FDA listed | — |
| Doxorubicin Hydrochloride 2 mg/mL 67457-0436-50 | Mylan | 1 vial | — | — | FDA listed | — |
| Doxorubicin Hydrochloride 2 mg/mL 00069-5629-05 | Pfizer | 1 vial | — | AP | FDA listed | — |
| Doxorubicin Hydrochloride 2 mg/mL 68083-0250-01 | Gland | 1 vial | — | AP | FDA listed | — |
| Doxorubicin Hydrochloride 2 mg/mL 63323-0101-61 | Fresenius | 1 vial | — | AP | FDA listed | — |
| doxorubicin hydrochloride 2 mg/mL 25021-0207-25 | Sagent | 1 vial | — | AP | FDA listed | — |
| Doxorubicin Hydrochloride 2 mg/mL 00143-9088-01 | Hikma | 1 vial | — | AP | FDA listed | — |
| Doxorubicin Hydrochloride 2 mg/mL 00143-9089-01 | Hikma | 1 vial | — | AP | FDA listed | — |
| Doxorubicin Hydrochloride 2 mg/mL 00143-9093-01 | Hikma | 1 vial | — | — | FDA listed | — |
| doxorubicin hydrochloride, Liposomal 2 mg/mL 00338-9581-02 | Baxter | 1 vial | — | — | FDA listed | — |
| Doxil 2 mg/mL 00338-9667-01 | Baxter | 1 vial | — | AB | FDA listed | — |
| Doxorubicin Hydrochloride 2 mg/mL 70710-1530-01 | Zydus | 1 vial | — | AB | FDA listed | — |
| Doxorubicin Hydrochloride 2 mg/mL 70748-0339-01 | Lupin | 1 vial | — | AB | FDA listed | — |
| doxorubicin hydrochloride 2 mg/mL 68001-0706-36 | BluePoint | 1 vial | — | AB | FDA listed | — |
| doxorubicin hydrochloride 2 mg/mL 68001-0707-26 | BluePoint | 1 vial | — | AB | FDA listed | — |
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 8, 2026
- FDA Orange Book · refreshed Oct 9, 2026
- CMS NADAC weekly file
Availability & generic status
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
Where does this data come from?
- FDA Orange Book · refreshed Oct 9, 2026
Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
🧪 Avoiding an ingredient? See Doxorubicin inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
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0.6 mg / 1 mL
UNII SU46BAM238
Ammonium sulfate is a mineral salt used in medications as a buffering agent and pH regulator. It helps maintain the chemical stability and balance of the drug formulation.
-
3.19 mg / 1 mL
UNII 97C5T2UQ7J
Cholesterol is a fatty substance found naturally in animal tissues. In medications, it's used as an ingredient in liposomal formulations and lipid-based drug delivery systems to help encapsulate and stabilize active drugs for better absorption.
-
UNII 4QD397987E
An amino acid used as a buffer and stabilizer in medications. It helps maintain the pH balance and protects the active drug from breaking down during storage and use.
-
UNII QTT17582CB
A strong acid used to adjust and maintain the proper pH level in liquid medicines, ensuring stability and preventing breakdown of active ingredients.
-
9.58 mg / 1 mL
UNII H1109Z9J4N
A natural emulsifier derived from soybean oil. It helps mix oil and water-based ingredients together, ensuring even distribution of active ingredients throughout the medicine.
-
3.19 mg / 1 mL
UNII 3L6NN8ZZKU
A synthetic lipid compound derived from polyethylene glycol and phospholipids. It functions as an emulsifier and solubilizer in medications, helping to stabilize and distribute oil and water-based ingredients evenly throughout the formulation.
-
UNII 55X04QC32I
A strong alkaline chemical used to adjust and maintain the pH balance of liquid medicines. It helps keep the medicine stable and ensures it stays effective during storage.
-
UNII C151H8M554
A natural sugar derived from sugar cane or sugar beets. It's used as a sweetener, filler, and binder to improve taste, add bulk, and help hold tablet or capsule ingredients together.
8 inactive ingredients listed in the exact product block matched to this NDC.
Where does this data come from?
ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.- FDA label on DailyMed · label index refreshed Oct 8, 2026
- FDA openFDA NDC Directory · synced Oct 8, 2026
Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
Why might an inactive ingredient be missing?
Can inactive ingredients matter?
Manufacturer & labeler
More NDCs from Zydus Lifesciences Limited labeler code 49315
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 8, 2026
- Drugs@FDA
Full prescribing information FDA SPL
📄 Package Label / Principal Display Panel ▾
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL 20 mg/10 mL Container Label 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 20 mg/10 mL Carton Label 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 50 mg/25 mL Container Label 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 50 mg/25 mL Carton Label 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 20 mg/10mL vial label 20 mg/10 mL carton label 50 mg/25mL vial label 50 mg/25 mL carton label
About this NDC listing & data coverage
What data is (and isn’t) available for this NDC — tap to expand
| NDC identity (package / product / labeler codes) | ✓ Available |
| Labeler | ✓ Available |
| Product & package description | ✓ Available |
| Marketing category & status | ✓ Available |
| Active ingredient / dosage form / route | ✓ Available |
| FDA label (SPL via DailyMed) | ✓ Available |
| Package photos | ✓ Available |
| Inactive ingredients (structured) | ✓ Available |
| NADAC pharmacy acquisition price (CMS) | — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey. |
| Orange Book / therapeutic-equivalence data | ✓ Available |
| HCPCS J-code billing crosswalk | — Not published for this NDC Most self-administered / retail products have no J-code — that is normal. |
| Medicaid utilization (CMS SDUD) | — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold. |