TISSEEL Fibrin Sealant fibrinogen human, human thrombin Kit
by Baxter Healthcare Corporation · 1 KIT in 1 CARTON (0338-4211-04) * 2 mL in 1 VIAL, GLASS (0338-7332-02) * 2 mL in 1 VIAL, GLASS (0338-7201-02) * 2 mL in 1 VIAL, GLASS (0338-7401-02) * 2 mL in 1 VIAL, GLASS (0338-7112-02)
NDC 00338-4211-04
🏷️ FDA NDC (as labeled)
0338-4211-04
billing pads the labeler segment with a zero
Brand
On market
Non-controlled
🗂️ Data synced Sep 17, 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)
0338-4211-04
Product NDC
0338-4211
11-digit billing NDC
00338421104
NCPDP billing unit
EA — each (per item)
Application #
BLA103980
SPL Set ID
b3f69e25-1b87-4507-81fa-582ea084673d
DEA schedule
Non-controlled
Marketing category
BLA
Marketing status
On market
FDA listing status
Listed (active directory)
Marketing start
1998-05-01
Dosage form
KIT
GPI-14
84209904106440
GPI class
Tisseel
GCN Seq No
078205
GCN
44489
HICL code
035889
Ingredient (HICL)
Thrombin/Fibrinog/Aprotin/Calc
HIC1 code
L
Therapeutic class — broad (HIC1)
Skin/Subcutaneous Tissue
HIC2 code
L9
Therapeutic class — intermediate (HIC2)
Dermatologic Preparations,Miscellaneous
HIC3 code
L9K
Therapeutic class — specific (HIC3)
Tissue/Wound Adhesives
AHFS code
84:92.00.00
AHFS class
Skin And Mucous Membrane Agents, Misc.
FDB label name
TISSEEL VHSD 4 ML KIT
FDB brand name
Tisseel Vhsd
Legend status
F — Federal legend — prescription drug or device
Biologic (Purple Book)
351(a)
Why two NDCs?
The FDA registers this code as 0338-4211-04 — a 4-4-2 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 labeler segment → 00338-4211-04. 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
LabelerBaxter Healthcare Corporation
FDA applicationBLA103980 (BLA)
Labeler code00338
First marketedMay 1998
Product typePlasma Derivative
Portfolio282 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 TISSEEL VHSD 4 ML KIT Ingredient Thrombin/Fibrinog/Aprotin/Calc
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.
💬 Questions about fibrinogen human, human thrombin?
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.
The FDA label contains product information, but this exact NDC could not be matched safely to one product block. We intentionally withheld sibling strengths’ ingredients.
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. | |
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
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 |
|---|---|---|---|---|---|---|
| TISSEEL Fibrin Sealant 00338-4210-02 | Baxter | 1 kit | — | — | FDA listed | — |
| TISSEEL Fibrin Sealant 00338-4301-02 | Baxter | 1 kit | — | — | FDA listed | — |
| TISSEEL Fibrin Sealant 00338-4303-10 | Baxter | 1 kit | — | — | FDA listed | — |
| TISSEEL Fibrin Sealant 00338-4212-10 | Baxter | 1 kit | — | — | FDA listed | — |
| TISSEEL Fibrin Sealantthis 00338-4211-04 | Baxter | 1 kit | — | — | FDA listed | — |
| TISSEEL Fibrin Sealant 00338-4302-04 | Baxter | 1 kit | — | — | 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.
⏳ Availability & biosimilar status
🏛️
1998
First FDA approval
May 1998
📍
2026
Currently FDA-listed
28 years listed
🧬
·
Biosimilars
see Purple Book
🧬Biologic — competition comes from biosimilars
Biologics have no small-molecule generics; biosimilar competition is tracked in the FDA Purple 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.
📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 00338-4211-04 You're viewing this | 1 KIT in 1 CARTON (0338-4211-04) * 2 mL in 1 VIAL, GLASS (0338-7332-02) * 2 mL in 1 VIAL, GLASS (0338-7201-02) * 2 mL in 1 VIAL, GLASS (0338-7401-02) * 2 mL in 1 VIAL, GLASS (0338-7112-02) | 1998-05-01 | Active |
🧭 About this NDC listing & data coverage
Kit / multi-component package
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) | ✓ Available |
| Package photos | ✓ Available |
| 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
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 FDA registers it as 0338-4211-04, 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: 00338-4211-04, written without dashes as 00338421104. 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 00338-4211-04, the first segment (00338) is the labeler code FDA assigned to Baxter Healthcare Corporation; the middle segment (4211) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (04) 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 Baxter Healthcare Corporation. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Baxter Healthcare Corporation 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.