Melphalan Hydrochloride Kit
by Actavis Pharma, Inc. · 1 KIT in 1 PACKAGE, COMBINATION (45963-686-02) * 10 mL in 1 VIAL, SINGLE-DOSE (45963-687-49) * 10 mL in 1 VIAL, SINGLE-USE (45963-688-57)
NDC 45963-0686-02
🏷️ FDA NDC (as labeled)
45963-686-02
billing pads the product segment with a zero
Rx only
Generic
Discontinued
Non-controlled
⚠ Discontinued by firm
🗂️ Data synced Mar 13, 2024 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →
⚠️
Excluded from the active FDA NDC Directory.
The labeler reported this product as discontinued, so it is excluded from the active NDC Directory. The listing was last certified through Apr 2026. A label may still appear on DailyMed, but the NDC is no longer in the current FDA NDC Directory.
Search the FDA NDC Directory ↗
🆔 Identity & classification
FDA NDC (as labeled)
45963-686-02
Product NDC
45963-686
11-digit billing NDC
45963068602
NCPDP billing unit
EA — each (per item)
Application #
ANDA206018
DEA schedule
Non-controlled
Marketing category
ANDA
Marketing status
Discontinued
FDA listing status
Discontinued by firm (certified through Apr 2026)
Route
INTRAVENOUS
Dosage form
KIT
GCN Seq No
019196
GCN
38232
HICL code
003895
Ingredient (HICL)
Melphalan Hcl
HIC1 code
V
Therapeutic class — broad (HIC1)
Neoplasms
HIC2 code
V1
Therapeutic class — intermediate (HIC2)
Antineoplastic Drugs
HIC3 code
V1A
Therapeutic class — specific (HIC3)
Antineoplastic - Alkylating Agents
AHFS code
10:00.00.00
AHFS class
Antineoplastic Agents
FDB label name
MELPHALAN 50 MG VIAL W-DILUENT
FDB brand name
Melphalan Hcl
Legend status
F — Federal legend — prescription drug or device
TE code (Orange Book)
AP · RLD · RS
Why two NDCs?
The FDA registers this code as 45963-686-02 — 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 → 45963-0686-02. 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.
🏭 Manufacturer & labeler
LabelerActavis Pharma, Inc.
Application holderACTAVIS LLC
FDA applicationANDA206018 (ANDA)
Labeler code45963
Product typeHuman Prescription Drug
Portfolio324 products on file
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.
🩺 Clinical
Label name MELPHALAN 50 MG VIAL W-DILUENT Ingredient Melphalan Hcl
📖 What it is MedlinePlus · NLM
Melphalan injection is used to treat multiple myeloma (a type of cancer of the bone marrow) in people who are unable to take melphalan by mouth. Melphalan injection is also used to destroy bone marrow and cancer cells in preparation for a bone marrow transplant in people with multiple myeloma. Melphalan is in a class of medications called alkylating agents. It works by stopping or slowing the growth of cancer cells in your body.
Read the full MedlinePlus article ↗📗 Our plain-language guide HelloPharmacist
- Melphalan is a chemotherapy drug used specifically to treat multiple myeloma, a type of blood cancer. Depending on which product you're getting, it may be used to prepare your body...
- Most people experience nausea, vomiting, diarrhea, fatigue, and mouth sores — these are common and your care team will give you medications to help manage them. More importantly, m...
- What side effects should I expect, and which ones should make me call my doctor right away?
- This is really important — melphalan can cause serious harm to an unborn baby, including birth defects and pregnancy loss. If you're pregnant, you need to talk to your doctor right...
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Melphalan Hydrochloride — tap one for details:
1
Nutrient depletion considerations
Melphalan Hydrochloride may be associated with lower levels of 1 nutrient — worth a chat with your pharmacist, not a cause for alarm.
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.
💬 Questions about Melphalan Hydrochloride?
Ask a pharmacist →
Ask a licensed pharmacist directly — free, answered by our team.
🧪 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.
Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured
IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.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.
💲 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. | |
| Medicare Part B allowsASP · J9245 | $104.898 / J9245 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)45963-686-02
11-digit billing NDC45963-0686-02
Format5-3-2 as registered → padded to 5-4-2 for billing (zero added to the product segment)
HCPCS J-codeJ9245
DescriptorINJECTION, MELPHALAN HYDROCHLORIDE, 50 MG
Billing units / pkg1 units
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.
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Melphalan hydrochloride 23155-0355-41 | Heritage | 1 kit | — | AP | FDA listed | — |
| Melphalan Hydrochloride 25021-0258-61 | Sagent | 1 kit | — | AP | FDA listed | — |
| Melphalan Hydrochloride 31722-0362-31 | Camber | 1 kit | — | AP | FDA listed | — |
| Melphalan Hydrochloride 43598-0392-48 | Dr.Reddy's | 1 kit | — | AP | FDA listed | — |
| Melphalan hydrochloride 54288-0109-02 | BPI | 1 kit | — | AP | FDA listed | — |
| Melphalan 63323-0760-20 | Fresenius | 1 kit | — | AP | FDA listed | — |
| Melphalan Hydrochloride 67184-0618-02 | Qilu | 1 kit | — | AP | FDA listed | — |
| Melphalan Hydrochloride 67457-0195-01 | Mylan | 1 kit | — | AP | FDA listed | — |
| Melphalan hydrochloride 68083-0259-01 | Gland | 1 kit | — | AP | FDA listed | — |
| Melphalan hydrochloride 71288-0132-90 | Meitheal | 1 kit | — | AP | FDA listed | — |
| Melphalan hydrochloride 72266-0128-01 | Fosun | 1 kit | — | AP | FDA listed | — |
| Evomela 50 mg/10mL 72893-0001-01 | Acrotech | 1 vial | — | — | FDA listed | — |
| Hepzato Kit 75833-0601-01 | Delcath | 1 kit | — | — | FDA listed | — |
| Melphalan Hydrochloride 75907-0112-11 | Dr.Reddy's | 1 kit | — | AP | FDA listed | — |
| Melphalan Hydrochloride 83634-0202-61 | Avenacy | 1 kit | — | AP | FDA listed | — |
| Melphalan Hydrochloride 84679-0001-01 | Arthur | 1 kit | — | AP | FDA listed | — |
| Melphalan Hydrochloridethis 45963-0686-02 | Actavis | 1 kit | — | AP | Discontinued | — |
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
📍
2026
Currently FDA-listed
listed with the FDA
🔓
·
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.
🔬 Reported adverse events (FAERS)
Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Melphalan Hydrochloride — the ingredient across all brands.
Top reported reactions
Age at onset
Reporter sex
Male · 55%
Female · 43%
Unknown · 2%
Serious outcomes
Reports over time (by year) — tap or hover for the count & year
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.
📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 45963-0686-02 You're viewing this | 1 KIT in 1 PACKAGE, COMBINATION (45963-686-02) * 10 mL in 1 VIAL, SINGLE-DOSE (45963-687-49) * 10 mL in 1 VIAL, SINGLE-USE (45963-688-57) | 2017-01-13 | Discontinued by firm |
🧭 About this NDC listing & data coverage
Finished prescription product
Kit / multi-component package
No longer marketed (per FDA listing data)
Kit / multi-component package
This NDC identifies a kit — a package containing more than one component. Structured data (pricing, ingredients, equivalents) is often reported per component rather than for the kit NDC itself, which can make this page look thinner than the components' own pages.
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) | — Not published for this NDC No structured label is linked to this listing in DailyMed/openFDA. |
| Package photos | — Not published for this NDC No photo available yet for this listing. |
| Inactive ingredients (structured) | — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is 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) | — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold. |
“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.
Why is there no full label on this page?
No structured FDA label (SPL) is currently linked to this NDC in DailyMed/openFDA. That can happen with older listings, certain OTC and repackaged products, and recently updated listings whose label has not yet propagated. The listing itself is still valid — this page shows everything the public feeds provide for this package.
What does the discontinued status mean for this NDC?
The labeler reported a marketing end date (or the listing was delisted), so this specific package is no longer actively marketed. Remaining stock may still be dispensed for a time, and the NDC stays valid for historical records and claims — but data feeds (pricing, labeling) typically stop updating for it. Other package sizes or other manufacturers' versions of the same medication may still be marketed — see the equivalents section where available.
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 FDA registers it as 45963-686-02, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 45963-0686-02, written without dashes as 45963068602. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 45963-0686-02, the first segment (45963) is the labeler code FDA assigned to Actavis Pharma, Inc.; the middle segment (0686) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (02) identifies this exact package size and type. Together they name one specific package of one specific product.
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 J9245 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.
📄 Full prescribing information FDA SPL
The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
📄 FDA label ▾
No FDA label is on file for this product yet. Labels load from openFDA / DailyMed and refresh weekly.
No label section mentions that — try another word, or open the full label on DailyMed below.
Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA.
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.