Wilate - von Willebrand Factor/Coagulation Factor VIII Complex (Human) 100 [iU]/mL; 100 [iU]/mL Powder, For Solution, 5 mL — NDC 68982-182-01 (Billing 68982-0182-01)
by Octapharma USA Inc · 5 mL in 1 VIAL
This is a package of 5 mL of Wilate - von Willebrand Factor/Coagulation Factor VIII Complex (Human) 100 [iU]/mL; 100 [iU]/mL Powder, For Solution from Octapharma USA Inc, marketed since Dec 2009 and currently FDA-listed.
NDC 68982-0182-01
🏷️ FDA NDC (as labeled)
68982-182-01
billing pads the product segment with a zero
This package
Contains5 mL
Medicaid pays$1.30 / unit · 12 mo
Per package$6.51 / 5 ml · Medicaid
Pack sizes2 compare ↓
🗂️ FDA directory synced Oct 8, 2026 · this listing last changed Oct 8, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →
NDC database record
One package, one record: these facts belong to NDC 68982-182-01 alone.
- Record
- FDA NDC Directory package listing · Plasma derivative
- Code segments
- 68982 labeler · 182 product · 01 package
- Package marketed since
- Dec 4, 2009
- Sample package
- No — commercial package
- Listing certified through
- Dec 31, 2027
- Barcode (UPC-A, from the NDC)
- 3 6898218201 6
- Medicaid fills, this package
- 159 prescriptions in the last four reported quarters
- FDA record last changed
- Oct 8, 2026
Identity & classification
Regulatory identifiers FDA, NLM and CMS codes for this package
FDA NDC (as labeled)
68982-182-01
Product NDC
68982-182
11-digit billing NDC
68982018201
NCPDP billing unit
EA — each (per item)
Application #
BLA125251
SPL Set ID
8b1223a8-df18-b5db-d5f5-6cc4889df0d4
Established class (EPC)
Human Antihemophilic Factor; Human Blood Coagulation Factor; Increased Platelet Aggrega
Physiologic effect
Increased Coagulation Activity
Chemical class
Blood Coagulation Factors; Factor VIII
DEA schedule
Non-controlled
Marketing category
BLA
Marketing status
On market
FDA listing status
Listed (active directory)
Marketing start
2009-12-04
Route
INTRAVENOUS
Dosage form
POWDER, FOR SOLUTION
Substance
ANTIHEMOPHILIC FACTOR HUMAN; VON WILLEBRAND FACTOR HUMAN
Biologic (Purple Book)
351(a)
Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification
GCN Seq No
069253
GCN
32238
HICL code
017395
Ingredient (HICL)
Antihemophilic Factor/Vwf
HIC1 code
M
Therapeutic class — broad (HIC1)
Blood
HIC2 code
M0
Therapeutic class — intermediate (HIC2)
Blood And Blood Replacement Preparations
HIC3 code
M0E
Therapeutic class — specific (HIC3)
Antihemophilic Factors
AHFS code
20:28.16.00
AHFS class
Hemostatics
FDB label name
WILATE 500-500 UNIT VIAL
FDB brand name
Wilate
Legend status
F — Federal legend — prescription drug or device
Quick answers
- GSN (GCN sequence number): 069253
- GCN: 32238
- HICL (First Databank): 017395
- AHFS class code: 20:28.16.00
Why two NDCs?
The FDA registers this code as 68982-182-01 — 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 → 68982-0182-01. 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.
- FDA openFDA NDC Directory · synced Oct 8, 2026
- FDA label on DailyMed · label index refreshed Oct 6, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 8, 2026
Clinical
Label name WILATE 500-500 UNIT VIAL Ingredient Antihemophilic Factor/Vwf
Patient education
Supplement & herbal interactions
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.
- MedlinePlus (NLM) · refreshed Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 6, 2026
💬 Questions about von Willebrand Factor/Coagulation Factor VIII Complex (Human)?
Ask a pharmacist →
Ask a licensed pharmacist directly — free, answered by our team.
Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per mL | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | $1.30 | $6.51 / 5 ml |
| Medicare drug plans payPart D · quarterly | No Part D plan price is available for this NDC in our data. | |
| Medicare Part B allowsASP · J7183 | $1.326 / J7183 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.
- CMS NADAC weekly file
- CMS ASP pricing files · refreshed Sep 20, 2026
- CMS Medicaid State Drug Utilization Data · through Q1 2026
- CMS Part D plan pricing files · refreshed Sep 24, 2026
- VA National Acquisition Center price file
Billing & reimbursement
FDA NDC (as labeled)68982-182-01
11-digit billing NDC68982-0182-01
Format5-3-2 as registered → padded to 5-4-2 for billing (zero added to the product segment)
HCPCS J-codeJ7183
DescriptorInjection, von willebrand factor complex (human), wilate, 1 i.u. vwf:rco
Billing units / pkg1 units
How the units are derivedThis package is 1; the HCPCS unit is 1 I.U. VWF:RCO, so one package = 1 billing unit.
Medicare Part B spend (2026 (Q1))$943,096 · 73 claims · $12,919.12 per claim (all NDCs under J7183)
Crosswalk sourceCMS ASP NDC-HCPCS Crosswalk
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.
- CMS ASP NDC-HCPCS crosswalk · refreshed Sep 22, 2026
- DMEPDAC NDC-HCPCS crosswalk
- openFDA NSDE billing units · refreshed Oct 7, 2026
Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Marketing end | Status |
|---|---|---|---|---|
| 68982-0182-01 You're viewing this | 5 mL in 1 VIAL | 2009-12-04 | — | Active |
| 68982-0182-02 68982-182-02 Main listing | 10 mL in 1 VIAL | 2009-12-04 | — | Active |
You're viewing the smallest of 2 pack sizes for this product.
This pack accounts for about 29% of this product's recent Medicaid fills; most go to the 10 ml pack. See all packs ↓
Pack size FAQ
What quantity is in this package?
This package contains 5 mL — 5 ml in 1 vial.
How does this package differ from NDC 68982-0182-02?
Both are Wilate - von Willebrand Factor/Coagulation Factor VIII Complex (Human) 100 [iU]/mL; 100 [iU]/mL Powder, For Solution — the drug itself is identical. This page's package is the 5 mL one, while NDC 68982-0182-02 is the 10 ml package.
What NDC number is used to bill for this package of Wilate - von Willebrand Factor/Coagulation Factor VIII Complex (Human) 100 [iU]/mL; 100 [iU]/mL Powder, For 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
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Wilate - von Willebrand Factor/Coagulation Factor VIII Complex (Human) 100 [iU]/mL; 100 [iU]/mLthis 68982-0182-01 | Octapharma | 5 ml | — | — | FDA listed | — |
About this product: this is a biologic. Biologics don't have small-molecule generics — competition comes from FDA-licensed biosimilars (shown above), not generics.
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.
- FDA openFDA NDC Directory · synced Oct 8, 2026
- FDA Purple Book · refreshed Oct 5, 2026
- CMS NADAC weekly file
Availability & biosimilar status
🏛️
2010
First FDA approval
Dec 2010
📍
2026
Currently FDA-listed
16 years listed
🔓
·
Biosimilar pathway open
listed protections lapsed 2022
🧬Biologic — competition comes from biosimilars
Biologics have no small-molecule generics; biosimilar competition is tracked in the FDA Purple Book.
🛡️ Latest patent/protection date listed: The latest listed FDA patent/protection lapsed Dec 2022 — those protections no longer apply, though a biosimilar still needs FDA licensure and a manufacturer to market it.
Why the date isn’t exact: Biosimilar timing can change because patents may be challenged, settled, licensed, added or removed, and litigation can move the real date earlier or later.
FDA Purple Book — biosimilars & interchangeables
ⓘ
Reference product
🔒 No FDA-licensed biosimilars or interchangeable biosimilars are listed yet for this biologic. It currently has no biosimilar competition in the FDA Purple Book.
Source: FDA Purple Book (purplebooksearch.fda.gov), matched on the reference product’s active ingredient.
Patents & exclusivity — FDA Purple Book
Exclusivity RefProduct
2010
2012
2014
2016
2018
2020
2022
Biologic patent
Exclusivity
🏛️Reference-product exclusivity
A flat 12 years of FDA market protection from first licensure. No biosimilar can be licensed before it ends — regardless of patents.
🧪Listed biologic patents
Patents the reference maker lists covering the molecule, formulation, or manufacturing. A biosimilar generally can’t launch until these resolve.
🔁Interchangeability
An interchangeable biosimilar may be substituted at the pharmacy (state laws vary). The first one can earn its own exclusivity period.
🛈 What do these terms mean?
- Biologic patent
- A patent the reference product’s maker has publicly listed. A biosimilar generally can’t launch until these expire — unless they’re invalidated or resolved in a settlement.
- Reference-product exclusivity
- A flat 12 years of FDA market protection from the biologic’s first licensure (the BPCIA). No biosimilar can be licensed before it ends, regardless of patents.
- Interchangeable exclusivity
- The first interchangeable biosimilar can earn a period as the only interchangeable version (pharmacists can substitute it without the prescriber).
- Earliest biosimilar (LOE)
- The latest of all the dates above — the soonest a biosimilar can realistically reach the market. Litigation and settlements can move it earlier.
Biologics have no small-molecule “generics” — competition comes from FDA-licensed biosimilars, tracked in the FDA Purple Book.
FDA exclusivity
| Code | What it grants | Expires |
|---|---|---|
| RefProduct | Reference-product exclusivity (12-year, BPCIA) — no biosimilar can be licensed before this date | Dec 20, 2022 |
Common questions
Is there a biosimilar for WILATE 500-500 UNIT VIAL?
No FDA-licensed biosimilar is currently listed for this biologic in the FDA Purple Book.
Why do different websites show different biosimilar dates?
Biosimilar availability isn’t based on one single date. Some sources use the reference-product exclusivity, some use the last listed patent, and patent litigation, settlements, and licenses can all change the real-world launch date. This page shows the underlying Purple Book dates so you can see why estimates differ.
Can a biosimilar launch before the last patent expires?
Sometimes. A biosimilar maker may settle with the reference manufacturer or receive a license to launch earlier. In other cases, the last listed protection delays competition.
What does “current Purple Book estimate” mean?
It means we’re using the latest patent and exclusivity dates currently listed in the FDA Purple Book. It is not a guaranteed launch date.
What does “FDA listed” mean?
It means the product appears in the FDA’s official directory. That’s a good sign a product exists for the U.S. market, but on its own it does not confirm a pharmacy can get it today. Where we have recent retail pricing data, we label it “Availability likely” instead.
What does a patent or protection date mean here?
It’s the latest date currently listed in the FDA Purple Book for a patent or exclusivity on the reference biologic. It can affect when a biosimilar becomes widely available — but it is not a guaranteed launch date. Settlements and licenses can move the real date earlier or later.
Built from the FDA Purple Book Patent List (patents the reference-product sponsor has publicly listed under the BPCIA) plus reference-product exclusivity. Biosimilars cannot launch until these clear; patent litigation and settlements can shift the real date. Biologics have no small-molecule generics — competition comes from FDA-licensed biosimilars, not the Orange Book.
Where does this data come from?
Patents and exclusivity from the FDA Purple Book (biologics), refreshed from public FDA data. Biosimilar launch timing is an estimate, not a guarantee.
- FDA Purple Book · refreshed Oct 5, 2026
Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
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.- FDA label on DailyMed · label index refreshed Oct 6, 2026
- FDA openFDA NDC Directory · synced Oct 8, 2026
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
LabelerOctapharma USA Inc
FDA applicationBLA125251 (BLA)
Labeler code68982
First marketedDec 2009
Product typePlasma Derivative
Portfolio24 products on file
More NDCs from Octapharma USA Inc labeler code 68982
- NUWIQ Antihemophilic Factor (Recombinant) Kit NDC 68982-143-01
- NUWIQ Antihemophilic Factor (Recombinant) Kit NDC 68982-145-01
- NUWIQ Antihemophilic Factor (Recombinant) Kit NDC 68982-147-01
- NUWIQ Antihemophilic Factor (Recombinant) Kit NDC 68982-149-01
- NUWIQ Antihemophilic Factor (Recombinant) Kit NDC 68982-151-01
- NUWIQ Antihemophilic Factor (Recombinant) Kit NDC 68982-153-01
- Balfaxar Prothrombin Complex Concentrate (Human) 25.5 [iU]/mL; 26 [iU]/mL; 16.5 [iU]/mL; 24 [iU]/mL; 22 [iU]/mL; 22 [iU]/mL Powder, For Solution NDC 68982-261-01
- Fibryga Fibrinogen (Human) Kit NDC 68982-347-01
- Fibryga Fibrinogen (Human) 20 mg/mL Powder, For Solution NDC 68982-349-01
- Fibryga Fibrinogen (Human) 20 mg/mL Powder, For Solution NDC 68982-350-01
- Albumin (Human) 50 g/1000mL Solution NDC 68982-623-01
- Albumin (Human) 200 g/1000mL Solution NDC 68982-633-01
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.
- FDA openFDA NDC Directory · synced Oct 8, 2026
- Drugs@FDA
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 ↗
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
159
Units reimbursed last 4 qtrs
373.3K
Gross reimbursed last 4 qtrs
$485.9K
Avg / prescription
$3,056.17
Avg / unit
$1.3019
Latest quarter Q1 2026
34Rx
Fee-for-service vs managed care ⓘ
Fee-for-service · 159 Rx Managed care · 0 Rx
State Medicaid map
Units reimbursed · per 100k residents
429911
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
Prescriptions—
Units—
Reimbursed—
🏆 Top states by units · per 100k residents
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.
Drug total (last 4 qtrs): 555 Rx · 5,901,240 units · $6,556,034 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
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 | ✓ 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 Octapharma USA 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 1 other package presentation of this same product, including 10 ml (68982-0182-02). 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?
Octapharma USA 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.
Does this product have a billing J-code?
Yes — this NDC cross-references HCPCS code J7183 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.
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.