Home › NDC Lookup › Ingredients › Doxorubicin Hydrochloride › 45963-0733-57
Doxorubicin hydrochloride 2 mg/mL Injection, Solution — NDC 45963-0733-57 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Doxorubicin hydrochloride 2 mg/mL Injection, Solution — NDC 45963-733-57 (Billing 45963-0733-57)

by Actavis Pharma, Inc. · 1 VIAL, SINGLE-DOSE in 1 CARTON / 10 mL in 1 VIAL, SINGLE-DOSE

This is a package of Doxorubicin hydrochloride 2 mg/mL Injection, Solution from Actavis Pharma, Inc., marketed since Nov 2014 and currently FDA-listed.

NDC 45963-0733-57
🏷️ FDA NDC (as labeled) 45963-733-57 billing pads the product segment with a zero
This package
Contains10 mL in 1 vial, single-dose Medicaid pays$1.82 / unit · 12 mo Per package$18.23 / 10 ml · Medicaid Pack sizes4 compare ↓
Product page 45963-0733-60 Also comes in: 5 mL 45963-733-55 100 mL 45963-733-60 25 mL 45963-733-68
Rx only Generic On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

NDC database record

One package, one record: these facts belong to NDC 45963-733-57 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
45963 labeler · 733 product · 57 package
Package marketed since
Nov 1, 2014
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC-A, from the NDC)
3 4596373357 3
Medicaid fills, this package
80 prescriptions in the last four reported quarters
FDA record last changed
Jul 24, 2026
⚠️
Other active recalls for Doxorubicin Hydrochloride (different manufacturers) — 1 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class I · May 12, 2026 — Presence of Particulate matter: Particulate matter identified as glass. (SUN PHARMACEUTICAL INDUSTRIES INC) · FDA recall D-0580-2026
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 45963-733-57
Product NDC 45963-733
11-digit billing NDC 45963073357
NCPDP billing unit ML — per mL (volume)
RxCUI 1191138, 1790097, 1790099, 1790100
UNII 82F2G7BL4E
Application # ANDA203622
SPL Set ID 33ddfdb1-b4bc-464d-a186-49c4b156279f
Established class (EPC) Anthracycline Topoisomerase Inhibitor
Mechanism of action Topoisomerase Inhibitors
Chemical class Anthracyclines
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2014-11-01
Route INTRAVENOUS
Dosage form INJECTION, SOLUTION
Substance DOXORUBICIN HYDROCHLORIDE
TE code (Orange Book) AP · RLD · RS

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GPI-14 21200040102010
GPI class DOXOrubicin HCl
GCN Seq No 064126
GCN 99835
HICL code 003916
Ingredient (HICL) Doxorubicin Hcl
HIC1 code V
Therapeutic class — broad (HIC1) Neoplasms
HIC2 code V1
Therapeutic class — intermediate (HIC2) Antineoplastic Drugs
HIC3 code V1D
Therapeutic class — specific (HIC3) Antibiotic Antineoplastics
AHFS code 10:00.00.00
AHFS class Antineoplastic Agents
FDB label name DOXORUBICIN 20 MG/10 ML VIAL
FDB brand name Doxorubicin Hcl
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 064126
  • GCN: 99835
  • GPI-14 (Medi-Span): 21200040102010
  • HICL (First Databank): 003916
  • AHFS class code: 10:00.00.00
  • RxCUI (RxNorm): 1191138
Why two NDCs? The FDA registers this code as 45963-733-57 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 45963-0733-57. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

RxNorm drug class

This medicine belongs to the Anthracycline Topoisomerase Inhibitor class.

Pharmacologic class Anthracycline Topoisomerase Inhibitor
Drug family (ATC) Anthracyclines and related substances
How it works Topoisomerase Inhibitors
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

Clinical

Label name DOXORUBICIN 20 MG/10 ML VIAL Ingredient Doxorubicin Hcl
📗 Our plain-language guide HelloPharmacist
  • 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...
📖 Read our full Doxorubicin guide →

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
1
Nutrient depletion considerations

Doxorubicin may be associated with lower levels of 1 nutrient — worth a chat with your pharmacist, not a cause for alarm.

🧪 Full Doxorubicin nutrient depletion report →
An association is not a deficiency. Educational only — don't start or stop anything without professional guidance.
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

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 systemPer mLPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo $1.82 $18.23 / 10 ml
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
Medicare Part B allowsASP · J9000 $2.710 / J9000 unit —
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Billing & reimbursement

FDA NDC (as labeled)45963-733-57
11-digit billing NDC45963-0733-57
Format5-3-2 as registered → padded to 5-4-2 for billing (zero added to the product segment)
HCPCS J-codeJ9000
DescriptorINJECTION, DOXORUBICIN HYDROCHLORIDE, 10 MG
Billing units / pkg0.2 units
How the units are derivedThis package is 10 ML; the HCPCS unit is 10 MG, so one package = 0.2 billing units.
Medicare Part B spend (2026 (Q1))$97,446 · 4,382 claims · $22.24 per claim (all NDCs under J9000)
Crosswalk sourcePDAC NDC-HCPCS crosswalk (DME MAC / DMEPOS)
Where does this data come from?
The HCPCS J-code crosswalk comes from the CMS ASP NDC-HCPCS crosswalk and the DMEPDAC (DME MAC) NDC-HCPCS crosswalk — free public CMS data. Billing units are derived from the code’s descriptor and the package amount.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
45963-0733-55 45963-733-55 1 VIAL, SINGLE-DOSE in 1 CARTON / 5 mL in 1 VIAL, SINGLE-DOSE 2014-11-01 — Active
45963-0733-57 You're viewing this 1 VIAL, SINGLE-DOSE in 1 CARTON / 10 mL in 1 VIAL, SINGLE-DOSE 2014-11-01 — Active
45963-0733-60 45963-733-60 Main listing 1 VIAL, MULTI-DOSE in 1 CARTON / 100 mL in 1 VIAL, MULTI-DOSE 2014-11-01 — Active
45963-0733-68 45963-733-68 1 VIAL, SINGLE-DOSE in 1 CARTON / 25 mL in 1 VIAL, SINGLE-DOSE 2014-11-01 — Active

This pack accounts for about 6.1% of this product's recent Medicaid fills; most go to a different pack size. See all packs ↓

Pack size FAQ

What quantity is in this package?
This package is listed by the FDA — 1 vial, single-dose in 1 carton / 10 ml in 1 vial, single-dose.
What NDC number is used to bill for this package of Doxorubicin hydrochloride 2 mg/mL Injection, Solution?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Doxorubicin Hydrochloride 2 mg/mL 49315-0008-03 Zydus 1 vial — AB FDA listed —
Doxorubicin Hydrochloride 2 mg/mL 49315-0009-07 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 68001-0345-26 BluePoint 1 vial — AB FDA listed —
Doxorubicin Hydrochloride 2 mg/mL 16714-0742-01 NorthStar 1 vial — AB Discontinued —
Doxorubicin Hydrochloride 2 mg/mL 16714-0856-01 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 68001-0704-26 BluePoint 1 vial — AB FDA listed —
Doxorubicin Hydrochloride 2 mg/mL 00069-0277-02 Pfizer 1 vial — AP FDA listed —
Doxorubicin hydrochloride 2 mg/mLthis 45963-0733-57 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 68083-0249-01 Gland 1 vial — AP 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 —
Doxil 2 mg/mL 00338-9665-01 Baxter 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 62332-0525-25 Alembic 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 70748-0340-01 Lupin 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 72603-0200-01 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 70710-1531-01 Zydus 1 vial — AB FDA listed —
doxorubicin hydrochloride 2 mg/mL 75907-0364-01 Dr. 1 vial — AB FDA listed —
Doxorubicin Hydrochloride 2 mg/mL 00069-5629-05 Pfizer 1 vial — AP FDA listed —
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 68083-0250-01 Gland 1 vial — AP FDA listed —
Doxorubicin Hydrochloride 2 mg/mL 47335-0050-40 Sun 1 vial — AB 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 —
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2014
On the market since
Nov 2014
📍
2026
Currently FDA-listed
12 years listed
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

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?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

What it looks like

Color red
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

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.

  • 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.
  • UNII 451W47IQ8X
    Sodium chloride is common table salt. It's used in medicines as a buffer to maintain proper pH, as a filler to add bulk, or to adjust the osmotic balance in liquid formulations.
  • UNII 059QF0KO0R
    Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.

3 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — 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.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

Manufacturer & labeler

LabelerActavis Pharma, Inc.
Application holderACTAVIS INC
FDA applicationANDA203622 (ANDA)
Labeler code45963
First marketedNov 2014
Product typeHuman Prescription Drug
Portfolio324 products on file

More NDCs from Actavis Pharma, Inc. labeler code 45963

The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🚨 Boxed Warning 🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients 🍼 Nursing Mothers 🧬 Pharmacokinetics 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📚 References 📄 Patient Package Insert 📄 Package Label / Principal Display Panel
🚨 Boxed Warning ~2 min read ▾

WARNING: CARDIOMYOPATHY, SECONDARY MALIGNANCIES, EXTRAVASATION AND TISSUE NECROSIS, and SEVERE MYELOSUPPRESSION Cardiomyopathy: Myocardial damage, including acute left ventricular failure, can occur with doxorubicin hydrochloride. The risk of cardiomyopathy is proportional to the cumulative exposure with incidence rates from 1% to 20% for cumulative doses ranging from 300 mg/m 2 to 500 mg/m 2 when doxorubicin hydrochloride is administered every 3 weeks. The risk of cardiomyopathy is further increased with concomitant cardiotoxic therapy.

Assess left ventricular ejection fraction (LVEF) before and regularly during and after treatment with doxorubicin hydrochloride [see Warnings and Precautions (5.1) ] . Secondary Malignancies: Secondary acute myelogenous leukemia (AML) and myelodysplastic syndrome (MDS) occur at a higher incidence in patients treated with anthracyclines, including doxorubicin hydrochloride [see Warnings and Precautions (5.2) ] . Extravasation and Tissue Necrosis: Extravasation of doxorubicin hydrochloride can result in severe local tissue injury and necrosis requiring wide excision of the affected area and skin grafting.

Immediately terminate the drug and apply ice to the affected area [see Warnings and Precautions (5.3) ] . Severe myelosuppression resulting in serious infection, septic shock, requirement for transfusions, hospitalization, and death may occur [see Warnings and Precautions (5.4) ] . WARNING: CARDIOMYOPATHY, SECONDARY MALIGNANCIES, EXTRAVASATION AND TISSUE NECROSIS, and SEVERE MYELOSUPPRESSION See full prescribing information for complete boxed warning.

Cardiomyopathy: Myocardial damage can occur with doxorubicin hydrochloride with incidences from 1% to 20% for cumulative doses from 300 mg/m 2 to 500 mg/m 2 when doxorubicin hydrochloride is administered every 3 weeks. The risk of cardiomyopathy is further increased with concomitant cardiotoxic therapy. Assess left ventricular ejection fraction (LVEF) before and regularly during and after treatment with doxorubicin hydrochloride.

( 5.1 ) Secondary Malignancies: Secondary acute myelogenous leukemia (AML) and myelodysplastic syndrome (MDS) occur at a higher incidence in patients treated with anthracyclines, including doxorubicin hydrochloride. ( 5.2 ) Extravasation and Tissue Necrosis: Extravasation of doxorubicin hydrochloride can result in severe local tissue injury and necrosis requiring wide excision and skin grafting. Immediately terminate the drug, and apply ice to the affected area.

( 5.3 ) Severe myelosuppression resulting in serious infection, septic shock, requirement for transfusions, hospitalization, and death may occur. ( 5.4 )

🎯 Indications and Usage 173 words ▾

1 INDICATIONS AND USAGE Doxorubicin Hydrochloride Injection is an anthracycline topoisomerase inhibitor indicated: as a component of multiagent adjuvant chemotherapy for treatment of women with axillary lymph node involvement following resection of primary breast cancer ( 1.1 ). for the treatment of: acute lymphoblastic leukemia, acute myeloblastic leukemia, Hodgkin lymphoma, Non-Hodgkin lymphoma, metastatic breast cancer, metastatic Wilms’ tumor, metastatic neuroblastoma, metastatic soft tissue sarcoma, metastatic bone sarcomas, metastatic ovarian carcinoma, metastatic transitional cell bladder carcinoma, metastatic thyroid carcinoma, metastatic gastric carcinoma, metastatic bronchogenic carcinoma ( 1.2 ).

1.1Adjuvant Breast Cancer Doxorubicin Hydrochloride Injection is indicated as a component of multi-agent adjuvant chemotherapy for treatment of women with axillary lymph node involvement following resection of primary breast cancer.

1.2Other Cancers Doxorubicin Hydrochloride Injection is indicated for the treatment of acute lymphoblastic leukemia acute myeloblastic leukemia Hodgkin lymphoma non-Hodgkin lymphoma (NHL) metastatic breast cancer metastatic Wilms’ tumor metastatic neuroblastoma metastatic soft tissue sarcoma metastatic bone sarcoma metastatic ovarian carcinoma metastatic transitional cell bladder carcinoma metastatic thyroid carcinoma metastatic gastric carcinoma metastatic bronchogenic carcinoma

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION Single agent : 60 to 75 mg/m 2 given intravenously every 21 days ( 2.1 ). In combination : 40 to 75 mg/m 2 given intravenously every 21 to 28 days ( 2.1 ). Discontinue Doxorubicin Hydrochloride Injection in patients who develop signs or symptoms of cardiomyopathy ( 2.2 ). Reduce dose in patients with hepatic impairment ( 2.3 ).

2.1Recommended Dosage for Adjuvant Breast Cancer The recommended dosage of Doxorubicin Hydrochloride Injection is 60 mg/m 2 administered as an intravenous bolus on day 1 of each 21-day treatment cycle, in combination with cyclophosphamide, for a total of four cycles.

2.2Recommended Dosage for Other Cancers The recommended dosage of Doxorubicin Hydrochloride Injection when used as a single agent is 60 mg/m 2 to 75 mg/m 2 intravenously every 21 days. The recommended dosage of Doxorubicin Hydrochloride Injection when administered in combination with other chemotherapy drugs, is 40 mg/m 2 to 75 mg/m 2 intravenously every 21 to 28 days. Consider use of the lower Doxorubicin Hydrochloride Injection dose in the recommended dosage range or longer intervals between cycles for heavily pretreated patients, elderly patients, or obese patients.

Cumulative doses above 550 mg/m 2 are associated with an increased risk of cardiomyopathy [see Warnings and Precautions ( 5.1 )] .

2.3Dosage Modifications for Adverse Reactions Cardiomyopathy Discontinue Doxorubicin Hydrochloride Injection in patients who develop signs or symptoms of cardiomyopathy [see Warnings and Precautions ( 5.1 )] .

2.4Dosage Modifications for Hepatic Impairment Doxorubicin Hydrochloride Injection is contraindicated in patients with severe hepatic impairment (Child-Pugh Class C or serum bilirubin greater than 5 mg/dL) [see Contraindications ( 4 )] . Dosage modifications for Doxorubicin Hydrochloride Injection in patients with elevated serum total bilirubin concentrations [see Warnings and Precautions ( 5.5 ), Use in Specific Populations ( 8.6 )] are provided in Table 1. Table 1.

Recommended Dosage Modification for Elevated Serum Total Bilirubin Serum total bilirubin concentration Dosage Modification 1.2 to 3 mg/dL 50% 3.1 to 5 mg/dL 75% greater than 5 mg/dL Do not initiate Doxorubicin Hydrochloride Injection; discontinue Doxorubicin Hydrochloride Injection

2.5Preparation and Administration Doxorubicin Hydrochloride Injection is a hazardous drug. Follow applicable special handling and disposal procedures. 1 Preparation Dilution of Doxorubicin Hydrochloride Injection Dilute Doxorubicin Hydrochloride Injection in 0.9% Sodium Chloride Injection, USP or 5% Dextrose Injection, USP.

Protect from light following preparation until completion of infusion. Use within 1 hour. If not used within 1 hour, discard the diluted product.

Administration Visually inspect for particulate matter and discoloration prior to administration, whenever solution and container permit. Discard if the solution is discolored, cloudy, or contains particulate matter. Administration by Intravenous Injection Administer diluted Doxorubicin Hydrochloride Injection as an intravenous injection through a central intravenous line or a secure and free-flowing peripheral venous line containing 0.9% Sodium Chloride Injection, USP, 0.45% Sodium Chloride Injection, USP, or 5% Dextrose Injection, USP.

Administer intravenously over 3 to 10 minutes. Decrease the rate of infusion if erythematous streaking along the vein proximal to the site of infusion or facial flushing occur. Administration by Continuous Intravenous Infusion Administer Doxorubicin Hydrochloride Injection solution only through a central intravenous line.

Decrease the rate of infusion if erythematous streaking along the vein proximal to the site of infusion or facial flushing occur. Protect from light from preparation for infusion until completion of infusion. Management of Suspected Extravasation Immediately discontinue Doxorubicin Hydrochloride Injection for burning or stinging sensation or other evidenc… [Excerpted — this section continues on DailyMed.]

💊 Dosage Forms and Strengths 65 words ▾

3 DOSAGE FORMS AND STRENGTHS Doxorubicin Hydrochloride Injection, USP: 10 mg/5 mL, 20 mg/10 mL and 50 mg/25 mL (2 mg/mL) clear red solution in a single-dose vial 200 mg/100 mL (2 mg/mL) clear red solution in a multiple-dose vial Injection: 10 mg/5 mL, 20 mg/10 mL, 50 mg/25 mL in single-dose vial ( 3 ) 200 mg/100 mL in multiple-dose vial ( 3 )

⛔ Contraindications 115 words ▾

4 CONTRAINDICATIONS Doxorubicin Hydrochloride Injection is contraindicated in patients with: Severe myocardial insufficiency [see Warnings and Precautions (5.1) ] Recent (occurring within the past 4 to 6 weeks) myocardial infarction [see Warnings and Precautions (5.1) ] Severe persistent drug-induced myelosuppression [see Warnings and Precautions (5.4) ] Severe hepatic impairment (defined as Child Pugh Class C or serum bilirubin level greater than 5 mg/dL) [see Warnings and Precautions (5.5) ] Severe hypersensitivity reaction to doxorubicin hydrochloride, including anaphylaxis [see Adverse Reactions (6.2) ] Severe myocardial insufficiency ( 4 ) Recent myocardial infarction ( 4 ) Severe persistent drug-induced myelosuppression ( 4 ) Severe hepatic impairment ( 4 ) Severe hypersensitivity to doxorubicin hydrochloride ( 4 )

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS Radiation-Induced Toxicity : Can be increased by the administration of Doxorubicin Hydrochloride Injection. Radiation recall can occur in patients who receive Doxorubicin Hydrochloride Injection after prior radiation therapy ( 5.7 ). Embryo-Fetal Toxicity : Can cause fetal harm.

Advise females of reproductive potential of the potential risk to a fetus and on the use of effective contraception. Advise males with female partners of reproductive potential to use effective contraception. Advise males with pregnant partners to use condoms ( 5.8 , 8.1 , 8.3 ).

5.1Cardiomyopathy and Arrhythmias Cardiomyopathy Doxorubicin hydrochloride can result in myocardial damage, including acute left ventricular failure. The risk of cardiomyopathy is generally proportional to the cumulative exposure. Include prior doses of other anthracyclines or anthracenediones in calculations of total cumulative dosage for doxorubicin hydrochloride.

Cardiomyopathy may develop during treatment or up to several years after completion of treatment and can include decrease in LVEF and signs and symptoms of congestive heart failure (CHF). The probability of developing cardiomyopathy is estimated to be 1 to 2% at a total cumulative dose of 300 mg/m 2 of doxorubicin hydrochloride, 3 to 5% at a dose of 400 mg/m 2 , 5 to 8% at a dose of 450 mg/m 2 , and 6 to 20% at a dose of 500 mg/m 2 , when doxorubicin hydrochloride is administered every 3 weeks. There is an additive or potentially synergistic increase in the risk of cardiomyopathy in patients who have received radiotherapy to the mediastinum or concomitant therapy with other known cardiotoxic agents, such as cyclophosphamide and trastuzumab.

Pericarditis and myocarditis have also been reported during or following doxorubicin hydrochloride treatment. Assess left ventricular cardiac function (e.g., MUGA or echocardiogram) prior to initiation of Doxorubicin Hydrochloride Injection, during treatment to detect acute changes, and after treatment to detect delayed cardiotoxicity. Increase the frequency of assessments as the cumulative dose exceeds 300 mg/m 2 .

Use the same method of assessment of LVEF at all time points [see Use in Specific Populations ( 8.4 )] . Discontinue Doxorubicin Hydrochloride Injection in patients who develop signs or symptoms of cardiomyopathy [see Dosage and Administration ( 2.3 )] . Consider the use of dexrazoxane to reduce the incidence and severity of cardiomyopathy due to doxorubicin hydrochloride administration in patients who have received a cumulative doxorubicin hydrochloride dose of 300 mg/m 2 and who will continue to receive doxorubicin hydrochloride.

Arrhythmias Doxorubicin hydrochloride can result in arrhythmias, including life-threatening arrhythmias, during or within a few hours after doxorubicin hydrochloride administration and at any time point during treatment. Tachyarrhythmias, including sinus tachycardia, premature ventricular contractions, and ventricular tachycardia, as well as bradycardia, can occur. Electrocardiographic changes, including non-specific ST-T wave changes, atrioventricular and bundle-branch block can also occur.

These electrocardiographic changes may be transient and self-limited and may not require a dosage modification of doxorubicin hydrochloride.

5.2Secondary Malignancies The risk of developing secondary acute myelogenous leukemia (AML) and myelodysplastic syndrome (MDS) is increased following treatment with doxorubicin hydrochloride. Cumulative incidences ranged from 0.2% at five years to 1.5% at 10 years in two separate trials involving the adjuvant treatment of women with breast cancer. These leukemias generally occur within 1 to 3 years of treatment.

5.3Extravasation and Tissue Necrosis Extravasation of doxorubicin hydrochloride can cause severe local tissue injury manifesting as blistering, ulceration, and necrosis requiring wide excision of the affected area and skin grafting. Extravasation should be considered if a pati… [Excerpted — this section continues on DailyMed.]

🤒 Adverse Reactions ~2 min read ▾

6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling. Cardiomyopathy and Arrhythmias [see Warnings and Precautions (5.1) ] Secondary Malignancies [see Warnings and Precautions (5.2) ] Extravasation and Tissue Necrosis [see Warnings and Precautions (5.3) ] Severe Myelosuppression [see Warnings and Precautions (5.4) ] Tumor Lysis Syndrome [see Warnings and Precautions (5.6) ] Radiation Sensitization and Radiation Recall [see Warnings and Precautions (5.7) ] The most common (>10%) adverse reactions are alopecia, nausea and vomiting ( 6.1 ).

To report SUSPECTED ADVERSE REACTIONS, contact Teva at 1-888-838-2872 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Breast Cance r The safety data below were collected from 1492 women who received doxorubicin hydrochloride at a dose of 60 mg/m 2 and cyclophosphamide at a dose of 600 mg/m 2 (AC) every 3 weeks for 4 cycles for the adjuvant treatment of axillary lymph node positive breast cancer.

The median number of cycles received was 4. Selected adverse reactions reported in this study are provided in Table 2. No treatment-related deaths were reported in patients on either arm of the study.

Table 2. Selected Adverse Reactions in Patients with Early Breast Cancer Involving Axillary Lymph Nodes Conventional Adverse Reactions AC* CMF N=1492 N=739 % % Alopecia 92 71 Vomiting Vomiting ≤12 hours 34 25 Vomiting >12 hours 37 12 Intractable 5 2 Leukopenia Grade 3 (1,000 to 1,999 /mm 3 ) 3.4

9.4Grade 4 (<1000 /mm 3 ) 0.3

0.3Shock, sepsis 2 1 Systemic infection 2 1 Cardiac dysfunction Asymptomatic 0.2

0.1Transient 0.1 0 Symptomatic 0.1 0 Thrombocytopenia Grade 3 (25,000 to 49,999 /mm 3 ) 0

0.3Grade 4 (<25,000 /mm 3 ) 0.1 0 AC = doxorubicin hydrochloride, cyclophosphamide; CMF = cyclophosphamide, methotrexate, fluorouracil * Includes pooled data from patients who received either AC for 4 cycles or AC for 4 cycles followed by CMF for 3 cycles

6.2Postmarketing Experience The following adverse reactions have been identified during post approval use of Doxorubicin Hydrochloride Injection. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Cardiac - Cardiogenic shock Cutaneous - Skin and nail hyperpigmentation, oncolysis, rash, itching, photosensitivity, urticaria, acral erythema, palmar plantar erythrodysesthesia Gastrointestinal - Nausea, mucositis, stomatitis, necrotizing colitis, typhlitis, gastric erosions, gastrointestinal tract bleeding, hematochezia, esophagitis, anorexia, abdominal pain, dehydration, diarrhea, hyperpigmentation of the oral mucosa Hypersensitivity - Anaphylaxis Laboratory Abnormalities - Increased ALT, increased AST Neurological - Peripheral sensory and motor neuropathy, seizures, coma Ocular - Conjunctivitis, keratitis, lacrimation Vascular - Phlebosclerosis, phlebitis/thrombophlebitis, hot flashes, thromboembolism Other - Malaise/asthenia, fever, chills, weight gain

🔄 Drug Interactions ~2 min read ▾

7 DRUG INTERACTIONS Avoid concomitant use of doxorubicin hydrochloride with inhibitors and inducers of CYP3A4, CYP2D6, and/or P-gp ( 7.1 ). Do not administer doxorubicin hydrochloride in combination with trastuzumab due to increased risk of cardiac dysfunction ( 5.1 , 7.2 ).

7.1Effect of Other Drugs on Doxorubicin Hydrochloride Injection Inhibitors of CYP3A4, CYP2D6, and P-gp Concomitant use of doxorubicin hydrochloride with inhibitors of CYP3A4, CYP2D6, or P-glycoprotein (P-gp), increased concentrations of doxorubicin hydrochloride, which may increase the incidence and severity of adverse reactions of doxorubicin hydrochloride. Avoid concomitant use of Doxorubicin Hydrochloride Injection with inhibitors of CYP3A4, CYP2D6, or P-gp. Inducers of CYP3A4, CYP2D6, or P-gp Concomitant use of doxorubicin hydrochloride with inducers of CYP3A4, CYP2D6, or P-gp may decrease the concentration of doxorubicin hydrochloride.

Avoid concomitant use of Doxorubicin Hydrochloride Injection with inducers of CYP3A4, CYP2D6, or P-gp. Paclitaxel Paclitaxel, when given prior to doxorubicin hydrochloride, increases the plasma-concentrations of doxorubicin hydrochloride and its metabolites. Administer Doxorubicin Hydrochloride Injection prior to paclitaxel if used concomitantly.

7.2Concomitant Use of Trastuzumab Concomitant use of trastuzumab and doxorubicin hydrochloride results in an increased risk of cardiac dysfunction. Avoid concomitant administration of Doxorubicin Hydrochloride Injection and trastuzumab [see Warnings and Precautions ( 5.1 )] . Patients receiving doxorubicin hydrochloride after stopping treatment with trastuzumab may also be at an increased risk of developing cardiotoxicity.

Trastuzumab may persist in the circulation for up to 7 months. Therefore, avoid anthracycline-based therapy for up to 7 months after stopping trastuzumab when possible. If anthracyclines are used before this time, carefully monitor cardiac function.

7.3Concomitant Use of Dexrazoxane Do not administer dexrazoxane as a cardioprotectant at the initiation of doxorubicin hydrochloride-containing chemotherapy regimens. In a randomized trial in women with metastatic breast cancer, initiation of dexrazoxane with doxorubicin hydrochloride-based chemotherapy resulted in a significantly lower tumor response rate (48% vs. 63%; p=0.007) and shorter time to progression compared to doxorubicin hydrochloride-based chemotherapy alone.

7.4Concomitant Use of 6-Mercaptopurine Doxorubicin hydrochloride may potentiate 6-mercaptopurine-induced hepatotoxicity. In 11 patients with refractory leukemia treated with 6-mercaptopurine (500 mg/m 2 intravenously daily for 5 days per cycle every 2 to 3 weeks) and doxorubicin hydrochloride (50 mg/m 2 intravenous once per cycle every 2 to 3 weeks) alone or with vincristine and prednisone, all developed hepatic dysfunction manifested by increased total serum bilirubin, alkaline phosphatase and aspartate aminotransferase.

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS Lactation : Advise not to breastfeed ( 8.2 ). Females and Males of Reproductive Potential : May impair fertility ( 8.3 ).

8.1Pregnancy Risk Summary Based on findings in animals and its mechanism of action, Doxorubicin Hydrochloride Injection can cause fetal harm when administered to a pregnant woman; avoid the use of Doxorubicin Hydrochloride Injection during the 1 st trimester. Available human data do not establish the presence or absence of major birth defects and miscarriage related to the use of doxorubicin hydrochloride during the 2 nd and 3 rd trimesters. Doxorubicin hydrochloride was teratogenic and embryotoxic in rats and embryotoxic in rabbits when administered during organogenesis at doses approximately 0.07 times (based on body surface area) the recommended human dose of 60 mg/m 2 (see Data) .

Advise pregnant women of the potential risk to a fetus. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Data Animal Data Doxorubicin hydrochloride was teratogenic and embryotoxic at doses of 0.8 mg/kg/day (about 0.07 times the recommended human dose based on body surface area) when administered during the period of organogenesis in rats.

Teratogenicity and embryotoxicity were also seen using discrete periods of treatment. The most susceptible was the 6- to 9-day gestation period at doses of 1.25 mg/kg/day and greater. Characteristic malformations included esophageal and intestinal atresia, tracheo-esophageal fistula, hypoplasia of the urinary bladder, and cardiovascular anomalies.

Doxorubicin hydrochloride was embryotoxic (increase in embryofetal deaths) and abortifacient at 0.4 mg/kg/day (about 0.07 times the recommended human dose based on body surface area) in rabbits when administered during the period of organogenesis.

8.2Lactation Risk Summary Doxorubicin hydrochloride was measured in the milk of one lactating patient after therapy with 70 mg/m 2 of doxorubicin hydrochloride given as a 15-minute intravenous infusion. The peak milk concentration at 24 hours after treatment was 4.4-fold greater than the corresponding plasma concentration. Doxorubicin hydrochloride was detectable in the milk up to 72 hours.

There are no data on the effects of doxorubicin hydrochloride on the breastfed child or the effects on milk production. Because of the potential for serious adverse reactions in the breastfed child, advise women not to breastfeed during treatment with Doxorubicin Hydrochloride Injection and for 10 days after the final dose.

8.3Females and Males of Reproductive Potential Pregnancy Testing Verify the pregnancy status of females of reproductive potential prior to initiating Doxorubicin Hydrochloride Injection. Contraception Females Doxorubicin Hydrochloride Injection can cause fetal harm when administered to pregnant women [see Use in Specific Populations ( 8.1 )] . Advise female patients of reproductive potential to use highly effective contraception during treatment with Doxorubicin Hydrochloride Injection and for 6 months after treatment [see Use in Specific Populations ( 8.1 )] .

Males Doxorubicin hydrochloride may damage spermatozoa and testicular tissue, resulting in possible genetic fetal abnormalities. Due to the potential for genotoxicity, advise males with female partners of reproductive potential to use effective contraception during treatment with Doxorubicin Hydrochloride Injection and for 3 months after treatment [see Nonclinical Toxicology ( 13.1 )] . Males with pregnant partners should use condoms during treatment and for at least 10 days after the final dose [see Nonclinical Toxicology ( 13.1 ), Use in Specific Populations ( 8.1 )] .

Infertility Females In females of reproductive potential, doxorubicin hydrochloride may cause infertility and result in amenorrhea. Premature menopause can occur. Recovery of menses and ovulation is related to age a… [Excerpted — this section continues on DailyMed.]

🤰 Pregnancy ~1 min read ▾

8.1Pregnancy Risk Summary Based on findings in animals and its mechanism of action, Doxorubicin Hydrochloride Injection can cause fetal harm when administered to a pregnant woman; avoid the use of Doxorubicin Hydrochloride Injection during the 1 st trimester. Available human data do not establish the presence or absence of major birth defects and miscarriage related to the use of doxorubicin hydrochloride during the 2 nd and 3 rd trimesters. Doxorubicin hydrochloride was teratogenic and embryotoxic in rats and embryotoxic in rabbits when administered during organogenesis at doses approximately 0.07 times (based on body surface area) the recommended human dose of 60 mg/m 2 (see Data) .

Advise pregnant women of the potential risk to a fetus. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Data Animal Data Doxorubicin hydrochloride was teratogenic and embryotoxic at doses of 0.8 mg/kg/day (about 0.07 times the recommended human dose based on body surface area) when administered during the period of organogenesis in rats.

Teratogenicity and embryotoxicity were also seen using discrete periods of treatment. The most susceptible was the 6- to 9-day gestation period at doses of 1.25 mg/kg/day and greater. Characteristic malformations included esophageal and intestinal atresia, tracheo-esophageal fistula, hypoplasia of the urinary bladder, and cardiovascular anomalies.

Doxorubicin hydrochloride was embryotoxic (increase in embryofetal deaths) and abortifacient at 0.4 mg/kg/day (about 0.07 times the recommended human dose based on body surface area) in rabbits when administered during the period of organogenesis.

🧒 Pediatric Use ~1 min read ▾

8.3Females and Males of Reproductive Potential Pregnancy Testing Verify the pregnancy status of females of reproductive potential prior to initiating Doxorubicin Hydrochloride Injection. Contraception Females Doxorubicin Hydrochloride Injection can cause fetal harm when administered to pregnant women [see Use in Specific Populations ( 8.1 )] . Advise female patients of reproductive potential to use highly effective contraception during treatment with Doxorubicin Hydrochloride Injection and for 6 months after treatment [see Use in Specific Populations ( 8.1 )] .

Males Doxorubicin hydrochloride may damage spermatozoa and testicular tissue, resulting in possible genetic fetal abnormalities. Due to the potential for genotoxicity, advise males with female partners of reproductive potential to use effective contraception during treatment with Doxorubicin Hydrochloride Injection and for 3 months after treatment [see Nonclinical Toxicology ( 13.1 )] . Males with pregnant partners should use condoms during treatment and for at least 10 days after the final dose [see Nonclinical Toxicology ( 13.1 ), Use in Specific Populations ( 8.1 )] .

Infertility Females In females of reproductive potential, doxorubicin hydrochloride may cause infertility and result in amenorrhea. Premature menopause can occur. Recovery of menses and ovulation is related to age at treatment [see Nonclinical Toxicology ( 13.1 )] .

Males Doxorubicin hydrochloride may result in oligospermia, azoospermia, and permanent loss of fertility. Sperm counts have been reported to return to normal levels in some men. This may occur several years after the end of therapy [see Nonclinical Toxicology ( 13.1 )] .

🧓 Geriatric Use 134 words ▾

8.4Pediatric Use Based on postmarketing reports, pediatric patients treated with doxorubicin hydrochloride are at risk for developing late cardiovascular dysfunction. Risk factors include young age at treatment (especially <5 years), high cumulative doses and receipt of combined modality therapy. Long-term periodic cardiovascular monitoring is recommended for all pediatric patients who have received doxorubicin hydrochloride.

Doxorubicin hydrochloride, as a component of intensive chemotherapy regimens administered to pediatric patients, may contribute to prepubertal growth failure and may also contribute to gonadal impairment, which is usually temporary. There are no recommended dose adjustments based on age. Doxorubicin hydrochloride clearance was increased in patients aged 2 years to 20 years as compared to adults, while doxorubicin hydrochloride clearance was similar in infants less than 2 years as compared to adults [see Clinical Pharmacology ( 12.3 )] .

🆘 Overdosage 131 words ▾

10 OVERDOSAGE Few cases of overdose have been described. A 58-year-old man with acute lymphoblastic leukemia received 10-fold overdose of doxorubicin hydrochloride (300 mg/m 2 ) in one day. He was treated with charcoal filtration, hemopoietic growth factor (G-CSF), proton pump inhibitor and antimicrobial prophylaxis.

The patient suffered sinus tachycardia, grade 4 neutropenia and thrombocytopenia for 11 days, severe mucositis and sepsis. The patient recovered completely 26 days after the overdose. A 17-year-old girl with osteogenic sarcoma received 150 mg of doxorubicin hydrochloride daily for 2 days (intended dose was 50 mg per day for 3 days).

The patient developed severe mucositis on days 4 to 7 after the overdose and chills and pyrexia on day 7. The patient was treated with antibiotics and platelets and recovered 18 days after overdose.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action The cytotoxic effect of doxorubicin hydrochloride on malignant cells and its toxic effects on various organs are thought to be related to nucleotide base intercalation and cell membrane lipid binding activities of doxorubicin hydrochloride. Intercalation inhibits nucleotide replication and action of DNA and RNA polymerases. The interaction of doxorubicin hydrochloride with topoisomerase II to form DNA-cleavable complexes appears to be an important mechanism of doxorubicin hydrochloride cytocidal activity.

12.3Pharmacokinetics Pharmacokinetic studies conducted in patients with various types of tumors have shown that doxorubicin hydrochloride follows multiphasic disposition after intravenous injection. In four patients, doxorubicin hydrochloride demonstrated dose-independent pharmacokinetics across a dose range of 30 mg/m 2 to 70 mg/m 2 . Distribution The distribution half-life is approximately 5 minutes.

Steady-state distribution volume ranges from 809 L/m 2 to 1214 L/m 2 . Binding of doxorubicin hydrochloride and its major metabolite, doxorubicinol, to plasma proteins is 75% and is independent of plasma concentration of doxorubicin hydrochloride up to 1.1 mcg/mL. Doxorubicin hydrochloride does not cross the blood brain barrier.

Elimination Plasma clearance is ranges from 324 mL/min/m 2 to 809 mL/min/m 2 . The terminal half-life is 20 hours to 48 hours. Metabolism Doxorubicin hydrochloride is a substrate of CYP3A4, CYP2D6, and P-gp.

Enzymatic reduction at the 7 position and cleavage of the daunosamine sugar yields aglycones which are accompanied by free radical formation, the local production of which may contribute to the cardiotoxic activity of doxorubicin hydrochloride. Disposition of doxorubicinol in patients is formation rate limited, with the terminal half-life of doxorubicinol being similar to doxorubicin hydrochloride. The relative exposure of doxorubicinol, i.e., the ratio between the AUC of doxorubicinol and the AUC of doxorubicin hydrochloride is approximately 0.5.

Excretion Plasma clearance is predominately by metabolism and biliary excretion. Approximately 40% of the dose appears in the bile in 5 days, while only 5% to 12% of the drug and its metabolites appear in the urine during the same time period. In urine, <3% of the dose was recovered as doxorubicinol over 7 days.

Specific Populations Weight Systemic clearance of doxorubicin hydrochloride is significantly reduced in obese women with ideal body weight greater than 130%. There was a significant reduction in clearance without any change in volume of distribution in obese patients when compared with normal patients with less than 115% ideal body weight. Pediatric Patients Following administration of doses ranging from 10 mg/m 2 to 75 mg/m 2 of doxorubicin hydrochloride to 60 patients ranging from 2 months to 20 years, doxorubicin hydrochloride clearance averaged 1443 ± 114 mL/min/m 2 .

Further analysis demonstrated that clearance in 52 patients ranging from 2 to 20 years (1540 mL/min/m 2 ) was increased compared with adults. However, clearance in infants younger than 2 years of age (813 mL/min/m 2 ) was decreased compared with older patients (ranging from 2 to 20 years) and approached the range of clearance values determined in adults [see Use in Specific Populations ( 8.4 )] . Sex A published clinical study involving 6 men and 21 women with no prior anthracycline therapy reported a significantly higher median doxorubicin hydrochloride clearance in men compared to women (1088 mL/min/m 2 versus 433 mL/min/m 2 ).

However, the terminal half-life of doxorubicin hydrochloride was longer in men compared to women (54 versus 35 hours). Patients with Hepatic Impairment The clearance of doxorubicin hydrochloride and doxorubicinol was reduced in patients with elevated serum total bilirubin concentrations [see Dosage and Administration ( 2.4 ), Warnings and Precautions ( 5.5 )] .

🧬 Mechanism of Action 72 words ▾

12.1Mechanism of Action The cytotoxic effect of doxorubicin hydrochloride on malignant cells and its toxic effects on various organs are thought to be related to nucleotide base intercalation and cell membrane lipid binding activities of doxorubicin hydrochloride. Intercalation inhibits nucleotide replication and action of DNA and RNA polymerases. The interaction of doxorubicin hydrochloride with topoisomerase II to form DNA-cleavable complexes appears to be an important mechanism of doxorubicin hydrochloride cytocidal activity.

📦 How Supplied / Storage and Handling 215 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Doxorubicin Hydrochloride Injection, USP is supplied in flip-top vials, as a clear, red solution containing doxorubicin hydrochloride USP, 2 mg/mL in the following package strengths: Unit of Sale Total Strength/Total Volume (Concentration) NDC 45963-733-55 Carton of 1 Single-dose Vial 10 mg/5 mL (2 mg/mL) NDC 45963-733-57 Carton of 1 Single-dose Vial 20 mg/10 mL (2 mg/mL) NDC 45963-733-68 Carton of 1 Single-dose Vial 50 mg/25 mL (2 mg/mL) NDC 45963-733-60 Carton of 1 Multiple-dose Vial 200 mg/100 mL (2 mg/mL) For the single dose vials: Store under refrigeration between 2°C to 8°C (36°F to 46°F).

Protect from light. Retain in carton until time of use. Discard unused portion.

For the multiple-dose vial: Store under refrigeration between 2°C to 8°C (36°F to 46°F). Protect from light. Retain in carton until contents are used.

Storage Storage of Doxorubicin Hydrochloride Injection, USP under refrigerated conditions can result in the formation of a gelled product. Place gelled product at room temperature [15ºC to 30ºC (59ºF to 86ºF)] for 2 to 4 hours to return the product to a slightly viscous, mobile solution. Handling and Disposal Doxorubicin Hydrochloride Injection, USP is a hazardous drug.

Follow applicable special handling and disposal procedures. 1 Sterile, Nonpyrogenic, Preservative-free. The vial stopper is not made with natural rubber latex.

📋 Description 196 words ▾

11 DESCRIPTION Doxorubicin hydrochloride, USP is an anthracycline topoisomerase inhibitor isolated from cultures of Streptomyces peucetius var. caesius . The chemical name of doxorubicin hydrochloride, USP is: 5,12-Naphthacenedione, 10-[(3-amino-2,3,6-trideoxy-α-L- lyxo -hexopyranosyl)oxy]-7,8,9,10­ tetrahydro-6,8,11-trihydroxy-8-(hydroxylacetyl)-1-methoxy-, hydrochloride (8 S-cis )-. The molecular weight of doxorubicin hydrochloride, USP is 579.98, and the molecular formula is C 27 H 29 NO 11 •HCl.

The chemical structure of doxorubicin hydrochloride, USP is: Doxorubicin Hydrochloride Injection USP, for intravenous use, is a clear red, sterile, isotonic aqueous solution provided in vials containing 10 mg/5 mL doxorubicin hydrochloride, USP (equivalent to 9.37 mg of doxorubicin free base), 20 mg/10 mL doxorubicin hydrochloride, USP (equivalent to 18.74 mg of doxorubicin free base), 50 mg/25 mL doxorubicin hydrochloride, USP (equivalent to 46.86 mg of doxorubicin free base), or 200 mg/100 mL of doxorubicin hydrochloride, USP (equivalent to 187.43 mg of doxorubicin free base).

The drug product has demonstrated inherent antimicrobial activity suitable for a multiple dose presentation. Each milliliter of solution contains 2 mg of doxorubicin hydrochloride, USP Inactive ingredients include 9 mg Sodium Chloride, USP and Water for Injection, USP, quantity sufficient. The pH of the solution is adjusted to 3.0 with hydrochloric acid, USP.

1

💬 Information for Patients ~2 min read ▾

17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Patient Information). Cardiomyopathy Advise patients that Doxorubicin Hydrochloride Injection can cause irreversible myocardial damage and to contact a healthcare provider for symptoms of heart failure during or after treatment [see Warnings and Precautions ( 5.1 )] . Secondary Malignancy Advise patients of the increased risk of treatment-related leukemia [see Warnings and Precautions ( 5.2 )] .

Myelosuppression Advise patients that Doxorubicin Hydrochloride Injection can reduce the absolute neutrophil count resulting in an increased risk of infection and to contact a healthcare provider for new onset fever or symptoms of infection [see Warnings and Precautions ( 5.4 )] . Embryo-Fetal Toxicity Advise pregnant women and females of reproductive potential of the potential risk to a fetus, and to inform their healthcare provider of a known or suspected pregnancy [see Warnings and Precautions ( 5.8 ), Use in Specific Populations ( 8.1 )] .

Advise females of reproductive potential to use effective contraception during treatment with Doxorubicin Hydrochloride Injection and for 6 months after treatment [see Warnings and Precautions ( 5.8 ), Use in Specific Populations ( 8.3 )] . Advise patients that Doxorubicin Hydrochloride Injection may induce chromosomal damage in sperm, which may lead to loss of fertility and offspring with birth defects. Advise males with female partners of reproductive potential to use effective contraception during treatment with Doxorubicin Hydrochloride Injection and for 3 months after treatment [see Warnings and Precautions ( 5.8 ), Use in Specific Populations ( 8.3 ), Nonclinical Toxicology ( 13.1 )] .

Advise males with pregnant partners to use condoms during treatment with Doxorubicin Hydrochloride Injection for at least 10 days after the final dose [see Use in Specific Populations ( 8.3 )] . Lactation Advise females not to breastfeed during treatment with Doxorubicin Hydrochloride Injection and for 10 days after the final dose [see Use in Specific Populations ( 8.2 )] . Infertility Advise females and males of the potential loss of fertility from Doxorubicin Hydrochloride Injection [see Use in Specific Populations ( 8.3 )] .

Gastrointestinal and Dermatologic Adverse Reactions Advise patients that Doxorubicin Hydrochloride Injection can cause nausea, vomiting, diarrhea, mouth/oral pain and sores and to contact a healthcare provider should they develop any severe symptoms that prevent them from eating and drinking [see Adverse Reactions ( 6 )] . Advise patients that Doxorubicin Hydrochloride Injection can cause alopecia [see Adverse Reactions ( 6.1 )] . Administration Advise patients that Doxorubicin Hydrochloride Injection can cause their urine to appear red for 1 to 2 days after administration.

Manufactured In Romania By: Sindan Pharma SRL Bucharest 1, Romania 011171 Manufactured For: Teva Pharmaceuticals Parsippany, NJ 07054 Rev. D 7/2024

🍼 Nursing Mothers 109 words ▾

8.2Lactation Risk Summary Doxorubicin hydrochloride was measured in the milk of one lactating patient after therapy with 70 mg/m 2 of doxorubicin hydrochloride given as a 15-minute intravenous infusion. The peak milk concentration at 24 hours after treatment was 4.4-fold greater than the corresponding plasma concentration. Doxorubicin hydrochloride was detectable in the milk up to 72 hours.

There are no data on the effects of doxorubicin hydrochloride on the breastfed child or the effects on milk production. Because of the potential for serious adverse reactions in the breastfed child, advise women not to breastfeed during treatment with Doxorubicin Hydrochloride Injection and for 10 days after the final dose.

🧬 Pharmacokinetics ~2 min read ▾

12.3Pharmacokinetics Pharmacokinetic studies conducted in patients with various types of tumors have shown that doxorubicin hydrochloride follows multiphasic disposition after intravenous injection. In four patients, doxorubicin hydrochloride demonstrated dose-independent pharmacokinetics across a dose range of 30 mg/m 2 to 70 mg/m 2 . Distribution The distribution half-life is approximately 5 minutes.

Steady-state distribution volume ranges from 809 L/m 2 to 1214 L/m 2 . Binding of doxorubicin hydrochloride and its major metabolite, doxorubicinol, to plasma proteins is 75% and is independent of plasma concentration of doxorubicin hydrochloride up to 1.1 mcg/mL. Doxorubicin hydrochloride does not cross the blood brain barrier.

Elimination Plasma clearance is ranges from 324 mL/min/m 2 to 809 mL/min/m 2 . The terminal half-life is 20 hours to 48 hours. Metabolism Doxorubicin hydrochloride is a substrate of CYP3A4, CYP2D6, and P-gp.

Enzymatic reduction at the 7 position and cleavage of the daunosamine sugar yields aglycones which are accompanied by free radical formation, the local production of which may contribute to the cardiotoxic activity of doxorubicin hydrochloride. Disposition of doxorubicinol in patients is formation rate limited, with the terminal half-life of doxorubicinol being similar to doxorubicin hydrochloride. The relative exposure of doxorubicinol, i.e., the ratio between the AUC of doxorubicinol and the AUC of doxorubicin hydrochloride is approximately 0.5.

Excretion Plasma clearance is predominately by metabolism and biliary excretion. Approximately 40% of the dose appears in the bile in 5 days, while only 5% to 12% of the drug and its metabolites appear in the urine during the same time period. In urine, <3% of the dose was recovered as doxorubicinol over 7 days.

Specific Populations Weight Systemic clearance of doxorubicin hydrochloride is significantly reduced in obese women with ideal body weight greater than 130%. There was a significant reduction in clearance without any change in volume of distribution in obese patients when compared with normal patients with less than 115% ideal body weight. Pediatric Patients Following administration of doses ranging from 10 mg/m 2 to 75 mg/m 2 of doxorubicin hydrochloride to 60 patients ranging from 2 months to 20 years, doxorubicin hydrochloride clearance averaged 1443 ± 114 mL/min/m 2 .

Further analysis demonstrated that clearance in 52 patients ranging from 2 to 20 years (1540 mL/min/m 2 ) was increased compared with adults. However, clearance in infants younger than 2 years of age (813 mL/min/m 2 ) was decreased compared with older patients (ranging from 2 to 20 years) and approached the range of clearance values determined in adults [see Use in Specific Populations ( 8.4 )] . Sex A published clinical study involving 6 men and 21 women with no prior anthracycline therapy reported a significantly higher median doxorubicin hydrochloride clearance in men compared to women (1088 mL/min/m 2 versus 433 mL/min/m 2 ).

However, the terminal half-life of doxorubicin hydrochloride was longer in men compared to women (54 versus 35 hours). Patients with Hepatic Impairment The clearance of doxorubicin hydrochloride and doxorubicinol was reduced in patients with elevated serum total bilirubin concentrations [see Dosage and Administration ( 2.4 ), Warnings and Precautions ( 5.5 )] .

🧪 Nonclinical Toxicology 151 words ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Doxorubicin hydrochloride treatment can increase the risk of secondary malignancies based on postmarketing reports [see Warnings and Precautions ( 5.2 )] . Doxorubicin hydrochloride was mutagenic in the in vitro Ames assay, and clastogenic in multiple in vitro assays (CHO cell, V79 hamster cell, human lymphoblast, and SCE assays) and the in vivo mouse micronucleus assay. Doxorubicin hydrochloride decreased fertility in female rats at the doses of 0.05 and 0.2 mg/kg/day (approximately 0.005 and 0.02 times the recommended human dose, based on body surface area).

A single intravenous dose of 0.1 mg/kg doxorubicin hydrochloride (approximately 0.01 times the recommended human dose based on body surface area) was toxic to male reproductive organs in animal studies, producing testicular atrophy, diffuse degeneration of the seminiferous tubules, and oligospermia/hypospermia in rats. Doxorubicin hydrochloride induces DNA damage in rabbit spermatozoa and dominant lethal mutations in mice.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 148 words ▾

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Doxorubicin hydrochloride treatment can increase the risk of secondary malignancies based on postmarketing reports [see Warnings and Precautions ( 5.2 )] . Doxorubicin hydrochloride was mutagenic in the in vitro Ames assay, and clastogenic in multiple in vitro assays (CHO cell, V79 hamster cell, human lymphoblast, and SCE assays) and the in vivo mouse micronucleus assay. Doxorubicin hydrochloride decreased fertility in female rats at the doses of 0.05 and 0.2 mg/kg/day (approximately 0.005 and 0.02 times the recommended human dose, based on body surface area).

A single intravenous dose of 0.1 mg/kg doxorubicin hydrochloride (approximately 0.01 times the recommended human dose based on body surface area) was toxic to male reproductive organs in animal studies, producing testicular atrophy, diffuse degeneration of the seminiferous tubules, and oligospermia/hypospermia in rats. Doxorubicin hydrochloride induces DNA damage in rabbit spermatozoa and dominant lethal mutations in mice.

📚 References 7 words ▾

15 REFERENCES “Hazardous Drugs”. OSHA . http://www.osha.gov/SLTC/hazardousdrugs/index.html

📄 Patient Package Insert ~3 min read ▾

PATIENT INFORMATION Doxorubicin Hydrochloride (dox" oh roo' bi sin hye" droe klor' ide) Injection What is the most important information I should know about Doxorubicin Hydrochloride Injection? Doxorubicin Hydrochloride Injection may cause serious side effects including: Heart muscle problems. Doxorubicin Hydrochloride Injection can cause heart muscle damage that may lead to heart failure.

Heart failure means your heart does not pump blood well. Heart failure is irreversible in some cases and can lead to death. Heart failure can happen during your treatment with Doxorubicin Hydrochloride Injection or months to years after stopping treatment.

Your risk of heart muscle damage increases with higher total amounts of Doxorubicin Hydrochloride Injection that you receive in your lifetime. Your risk of heart failure is higher if you: have other heart problems have had or are currently receiving radiation therapy to your chest have had treatment with certain other anti-cancer medicines take other medicines that can have severe side effects on your heart Tell your healthcare provider if you get any of these symptoms of heart failure during or after treatment with Doxorubicin Hydrochloride Injection: extreme tiredness or weakness fast heartbeat shortness of breath swelling of your feet and ankles Your healthcare provider will do tests to check the strength of your heart muscle before, during, and after your treatment with Doxorubicin Hydrochloride Injection.

Heart rhythm problems. Doxorubicin Hydrochloride Injection can cause serious heart rhythm problems that may lead to death. This can happen during your infusion, within a few hours after your infusion or anytime during treatment with Doxorubicin Hydrochloride Injection.

Tell your healthcare provider if you get any symptoms of heart rhythm problems, such as feeling as if your heart is beating fast, irregular or slow, or you feel lightheaded, dizzy, short of breath, chest discomfort or you faint. Risk of new cancers. You may have an increased risk of developing certain blood cancers called acute myelogenous leukemia (AML) or myelodysplastic syndrome (MDS) after treatment with Doxorubicin Hydrochloride Injection.

Talk with your healthcare provider about your risk of developing new cancers if you receive Doxorubicin Hydrochloride Injection. Skin damage at or near the vein where doxorubicin hydrochloride is given. Doxorubicin Hydrochloride Injection can damage the skin if it leaks out of the vein and might cause blisters, skin sores or severe tissue damage, which may require skin grafts.

Tell your healthcare provider if you get burning or stinging during your infusion. Decreased blood cell counts . Doxorubicin Hydrochloride Injection can cause a decrease in neutrophils (a type of white blood cell important in fighting bacterial infections) and platelets (important for clotting and to control bleeding).

This may lead to a serious infection, the need for blood transfusions, treatment in a hospital or death. Your healthcare provider will check your blood cell counts before each infusion and during treatment with Doxorubicin Hydrochloride Injection. Call your healthcare provider right away if you get a fever (temperature of 100.4°F or higher) or chills with shivering.

What is Doxorubicin Hydrochloride Injection? Doxorubicin Hydrochloride Injection is a prescription medicine used to treat certain types of cancers. Doxorubicin Hydrochloride Injection may be used alone or along with other anti-cancer medicines.

Do not receive Doxorubicin Hydrochloride Injection if: you have had a recent heart attack (within the past 4 to 6 weeks) or have severe heart problems. your blood cell counts (platelets, red blood cells, and white blood cells) are very low because of prior chemotherapy. you have severe liver problems. you have had a severe allergic reaction to Doxorubicin Hydrochloride Injection Before you receive Doxorubicin Hydrochloride Injection, tell your healthcare provider about all of your medical… [Excerpted — this section continues on DailyMed.]

📄 Package Label / Principal Display Panel 133 words ▾

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 45963-733-55 Doxorubicin Hydrochloride Injection USP 10 mg/5 mL (2 mg/mL) For Intravenous Use Only Warning: Hazardous Drug Rx only 5 mL Single-Dose Vial carton 10mg carton 10mg

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 45963-733-57 Doxorubicin Hydrochloride Injection USP 20 mg/10 mL (2 mg/mL) For Intravenous Use Only Warning: Hazardous Drug Rx only 10 mL Single-Dose Vial carton 20 mg carton 20 mg

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 45963-733-68 Doxorubicin Hydrochloride Injection USP 50 mg/25 mL (2 mg/mL) For Intravenous Use Only Warning: Hazardous Drug Rx only 25 mL Single-Dose Vial carton 50 mg carton 50 mg

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 45963-733-60 Doxorubicin Hydrochloride Injection USP 200mg/100 mL (2 mg/mL) For Intravenous Use Only Warning: Hazardous Drug Rx only 100 mL Multi-Dose Vial carton 200 mg carton 200 mg

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for this package alone, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q1 2026 · 5 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
80
Units reimbursed last 4 qtrs
3.2K
Gross reimbursed last 4 qtrs
$5.8K
Avg / prescription
$72.02
Avg / unit
$1.8233
Latest quarter Q1 2026
0Rx
Fee-for-service vs managed care ⓘ
100% MCO
Fee-for-service · 0 Rx Managed care · 80 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: no data reported WA Idaho: no data reported ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: no data reported MN Wisconsin: no data reported WI Michigan: no data reported MI New York: no data reported NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: no data reported OR Nevada: 965 units · 30.2 per 100k residents NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: no data reported IA Illinois: no data reported IL Indiana: no data reported IN Ohio: no data reported OH Pennsylvania: no data reported PA New Jersey: no data reported NJ Massachusetts: no data reported MA California: no data reported CA Utah: no data reported UT Colorado: no data reported CO Nebraska: no data reported NE Missouri: no data reported MO Kentucky: no data reported KY West Virginia: no data reported WV Virginia: no data reported VA Maryland: no data reported MD Connecticut: no data reported CT Rhode Island: no data reported RI Arizona: no data reported AZ New Mexico: no data reported NM Kansas: no data reported KS Arkansas: no data reported AR Tennessee: no data reported TN North Carolina: no data reported NC South Carolina: no data reported SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: no data reported LA Mississippi: no data reported MS Alabama: no data reported AL Georgia: no data reported GA D.C.: no data reported DC Hawaii: no data reported HI Texas: no data reported TX Florida: no data reported FL
Units reimbursed · per 100k residents
30.230.2
gray = no data reported ⓘ
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 Nevada 30.2 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

Medicaid utilization by pack size

Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.
1 vial45963-0733-60 916 Rx · $34,972
1 vial45963-0733-68 307 Rx · $21,076
1 vial this page45963-0733-57 80 Rx · $5,762
1 vial45963-0733-55 No Medicaid data
Drug total (last 4 qtrs): 1,303 Rx · 58,564 units · $61,809 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

About this NDC listing & data coverage

Finished prescription product
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 ✓ Available
Medicaid utilization (CMS SDUD) ✓ Available
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Actavis Pharma, Inc.. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 3 other package presentations of this same product, including 1 vial (45963-0733-55), 1 vial (45963-0733-60), 1 vial (45963-0733-68). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
Actavis Pharma, Inc. is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
Does this product have a billing J-code?
Yes — this NDC cross-references HCPCS code J9000 for medical-claim billing (typically used when a product is administered in a clinical setting rather than dispensed at a retail pharmacy). See the Billing section on this page.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.
← 45963-0709-11 · Actavis 45963-0734-54 · Actavis →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.