Hydroxyurea 1 g/g Powder, 100 g
by Spectrum Laboratory Products, Inc. · 100 g in 1 CONTAINER (49452-3650-2)
NDC 49452-3650-02
🏷️ FDA NDC (as labeled)
49452-3650-2
billing pads the package segment with a zero
This package
Contains100 g
Pack sizes6 compare ↓
Also comes in:
25 gs 49452-3650-01
50 gs 49452-3650-07
500 gs 49452-3650-03
12000 gs 49452-3650-05
25000 gs 49452-3650-06
On market
Non-controlled
🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →
🆔 Identity & classification
FDA NDC (as labeled)
49452-3650-2
Product NDC
49452-3650
11-digit billing NDC
49452365002
SPL Set ID
24b124cb-61e9-fec5-e063-6394a90a5c97
DEA schedule
Non-controlled
Marketing category
BULK INGREDIENT
Marketing status
On market
FDA listing status
Listed (active directory)
Marketing start
1999-11-01
Dosage form
POWDER
Substance
HYDROXYUREA
GPI-14
96568814202900
GPI class
Hydroxyurea
GCN Seq No
060202
GCN
26266
HICL code
003897
Ingredient (HICL)
Hydroxyurea
HIC1 code
U
Therapeutic class — broad (HIC1)
Miscell. Drugs/ Pharmaceutical Adjuvants
HIC2 code
U6
Therapeutic class — intermediate (HIC2)
Pharmaceutical Adjuvants
HIC3 code
U6W
Therapeutic class — specific (HIC3)
Bulk Chemicals
AHFS code
10:00.00.00
AHFS class
Antineoplastic Agents
FDB label name
HYDROXYUREA POWDER
FDB brand name
Hydroxyurea
Legend status
F — Federal legend — prescription drug or device
Why two NDCs?
The FDA registers this code as 49452-3650-2 — a 5-4-1 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 package segment → 49452-3650-02. 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
LabelerSpectrum Laboratory Products, Inc.
Labeler code49452
First marketedNov 1999
Product typeBulk Ingredient
Portfolio234 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 HYDROXYUREA POWDER Ingredient Hydroxyurea
📗 Our plain-language guide HelloPharmacist
- It's actually both, depending on the specific product. Droxia, Siklos, and Xromi are each approved to reduce the painful crises and blood transfusion needs in sickle cell anemia. H...
- What exactly is hydroxyurea used for — is it a cancer drug or a sickle cell drug?
- Very regularly — typically every two weeks while your dose is being adjusted. Hydroxyurea can lower your white blood cell and platelet counts, so monitoring is built into the treat...
- How often will I need blood tests while I'm on this medication?
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Hydroxyurea — tap one for details:
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 Hydroxyurea?
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.
We could not link this NDC to a current FDA Structured Product Label. An inactive-ingredient list is therefore not available from this source.
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 g | 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. | |
ℹ️
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.
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Hydroxyurea 1 g/g 62049-0135-04 | Genvion | 25 gs | — | — | FDA listed | — |
| Hydroxyurea 1 g/gthis 49452-3650-02 | Spectrum | 100 gs | — | — | FDA listed | — |
| Hydroxyurea 1 g/g 38779-1354-04 | Medisca | 25 gs | — | — | FDA listed | — |
About this product: other versions of the same ingredient, strength and form are listed above, least expensive first, with FDA equivalence ratings where available.
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
🏛️
1999
On the market since
Nov 1999
📍
2026
Currently FDA-listed
27 years listed
🔒
·
No generic listed yet
brand only
ℹ️No FDA-approved generic found
We did not find an FDA-approved generic match for this exact strength, form and route.
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.
📊 Medicare Part D spend CMS · PART D · 2026 (Q1)
Medicare Part D (outpatient prescription) spending for Hydroxyurea (matched by generic name) — the program that covers self-administered drugs. 7 manufacturers.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Hydroxyurea. CMS lists 5 products for this generic; we show the highest-spend one. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$3.05M
Claims incl. refills
142.4K
Beneficiaries
92.8K
Spend / beneficiary
$32.83
Spend / claim
$21.38
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.
🔬 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 Hydroxyurea — the ingredient across all brands.
Top reported reactions
Age at onset
Reporter sex
Male · 47%
Female · 52%
Unknown · 0%
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 |
|---|---|---|---|
| 49452-3650-01 | 25 g in 1 CONTAINER (49452-3650-1) | — | Active |
| 49452-3650-02 You're viewing this | 100 g in 1 CONTAINER (49452-3650-2) | — | Active |
| 49452-3650-03 | 500 g in 1 CONTAINER (49452-3650-3) | — | Active |
| 49452-3650-05 | 12000 g in 1 CONTAINER (49452-3650-5) | — | Active |
| 49452-3650-06 | 25000 g in 1 CONTAINER (49452-3650-6) | — | Active |
| 49452-3650-07 | 50 g in 1 CONTAINER (49452-3650-7) | — | Active |
You're viewing one of 6 pack sizes for this product.
Pack size FAQ
What quantity is in NDC 49452-3650-02?
NDC 49452-3650-02 contains 100 g — 100 g in 1 container.
What is the difference between NDC 49452-3650-02 and NDC 49452-3650-01?
Both are Hydroxyurea 1 g/g Powder — the drug itself is identical. NDC 49452-3650-02 is the 100 g package, while NDC 49452-3650-01 is the 25 gs package.
What NDC number is used to bill for this package of Hydroxyurea 1 g/g Powder?
Bill NDC 49452-3650-02 — the 11-digit billing format is 49452365002. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.
🧭 About this NDC listing & data coverage
Bulk ingredient (not a finished retail product)
This is a bulk ingredient listing — not a retail prescription package
Hydroxyurea 1 g/g POWDER is listed with FDA as a bulk ingredient (a drug substance supplied for further manufacturing or licensed pharmacy compounding). It is not a finished product a patient would receive at a retail pharmacy, so consumer-style information — a patient label, retail pricing, package photos — generally does not exist for this NDC. The listing identifies the substance and package for supply-chain and regulatory purposes.
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 | — 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 | — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope. |
| HCPCS J-code billing crosswalk | — Not published for this NDC Most self-administered / retail products have no J-code — that is normal. |
| Medicaid utilization (CMS SDUD) | — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold. |
“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
Is this NDC FDA-approved?
An NDC listing does not by itself establish FDA approval — the NDC Directory records that a product is listed with FDA, not that it was reviewed and approved. This listing's marketing category is "Bulk Ingredient". Products approved under an application carry an NDA, ANDA, or BLA number.
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.
Can I get this product filled at a pharmacy?
Not as listed here. A bulk ingredient NDC identifies drug substance supplied for manufacturing or licensed compounding — it is not a finished, dispensable package. A pharmacy prescription would involve a finished product with its own NDC.
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 49452-3650-2, 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: 49452-3650-02, written without dashes as 49452365002. 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 49452-3650-02, the first segment (49452) is the labeler code FDA assigned to Spectrum Laboratory Products, Inc.; the middle segment (3650) 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.
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 Spectrum Laboratory Products, 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 5 other package presentations of this same product, including 25 gs (49452-3650-01), 50 gs (49452-3650-07), 500 gs (49452-3650-03). 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?
Spectrum Laboratory Products, 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.
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 FDA label FDA SPL
The complete FDA label for this product, 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.
Prefer the government’s original formatting? View this label on DailyMed ↗
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.