Plasma derivative · BLA
TISSEEL Fibrin Sealant (Fibrinogen human, human thrombin) NDC 0338-4303
Kit · Baxter Healthcare Corporation
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0338-4303-10 | 00338430310 | 1 KIT in 1 CARTON (0338-4303-10) * 5 mL in 1 VIAL, GLASS (0338-7332-05) * 5 mL in 1 VIAL, GLASS (0338-7201-05) * 5 mL in 1 VIAL, GLASS (0338-7401-05) * 5 mL in 1 VIAL, GLASS (0338-7112-05)Marketed from May 1, 1998 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- TISSEEL Fibrin SealantSuffix: Fibrin Sealant
- Generic name (nonproprietary)
- fibrinogen human, human thrombin
- Dosage form
- Kit
- Labeler
- Baxter Healthcare CorporationNDC labeler code 0338
- Product type
- Plasma derivative
- Marketing category
- BLA — Biologics License ApplicationApplication BLA 103980
- Marketing start
- Listing expires
- Identifiers
- Product ID 0338-4303_e704d5a7-9db0-4f0f-8267-7ea92d8d882eSPL ID e704d5a7-9db0-4f0f-8267-7ea92d8d882e
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.
- NDC on a medical claim
N400338430310followed by a unit qualifier and the quantityPackage 00338-4303-10. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
The FDA listing for this product does not reference a label (SPL) set.
About NDC 0338-4303
- What is NDC 0338-4303?
- 0338-4303 is the product NDC for TISSEEL Fibrin Sealant kit, listed with the FDA by Baxter Healthcare Corporation. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- TISSEEL Fibrin Sealant (Fibrinogen human, human thrombin).
- Who is the labeler?
- Baxter Healthcare Corporation, NDC labeler code 0338. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for TISSEEL Fibrin Sealant?
- 8 other product NDCs are listed under this name. See all TISSEEL Fibrin Sealant NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other TISSEEL Fibrin Sealant products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| TISSEEL Fibrin Sealantfibrinogen human, human thrombin | — | Kit | Baxter Healthcare Corporation | 0338-4210 | 00338-4210-02 |
| TISSEEL Fibrin Sealantfibrinogen human, human thrombin | — | Kit | Baxter Healthcare Corporation | 0338-4211 | 00338-4211-04 |
| TISSEEL Fibrin Sealantfibrinogen human, human thrombin | — | Kit | Baxter Healthcare Corporation | 0338-4212 | 00338-4212-10 |
| TISSEEL Fibrin Sealantfibrinogen human, human thrombin | — | Kit | Baxter Healthcare Corporation | 0338-4301 | 00338-4301-02 |
| TISSEEL Fibrin Sealantfibrinogen human, human thrombin | — | Kit | Baxter Healthcare Corporation | 0338-4302 | 00338-4302-04 |
| TISSEEL Fibrin Sealantfibrinogen human, human thrombin | Fibrinogen human 86.5 mg/mL; Human thrombin 500 [iU]/mL | SolutionTopical | Baxter Healthcare Corporation | 0338-9560 | 00338-9560-01 |
| TISSEEL Fibrin Sealantfibrinogen human, human thrombin | Fibrinogen human 86.5 mg/mL; Human thrombin 500 [iU]/mL | SolutionTopical | Baxter Healthcare Corporation | 0338-9564 | 00338-9564-01 |
| TISSEEL Fibrin Sealantfibrinogen human, human thrombin | Fibrinogen human 86.5 mg/mL; Human thrombin 500 [iU]/mL | SolutionTopical | Baxter Healthcare Corporation | 0338-9568 | 00338-9568-01 |
Other NDCs under BLA 103980
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| TISSEEL Fibrin Sealantfibrinogen human, human thrombin | — | Kit | Baxter Healthcare Corporation | 0338-4210 |
| TISSEEL Fibrin Sealantfibrinogen human, human thrombin | — | Kit | Baxter Healthcare Corporation | 0338-4211 |
| TISSEEL Fibrin Sealantfibrinogen human, human thrombin | — | Kit | Baxter Healthcare Corporation | 0338-4212 |
| TISSEEL Fibrin Sealantfibrinogen human, human thrombin | — | Kit | Baxter Healthcare Corporation | 0338-4301 |
| TISSEEL Fibrin Sealantfibrinogen human, human thrombin | — | Kit | Baxter Healthcare Corporation | 0338-4302 |
| TISSEEL Fibrin Sealantfibrinogen human, human thrombin | Fibrinogen human 86.5 mg/mL; Human thrombin 500 [iU]/mL | SolutionTopical | Baxter Healthcare Corporation | 0338-9560 |
| TISSEEL Fibrin Sealantfibrinogen human, human thrombin | Fibrinogen human 86.5 mg/mL; Human thrombin 500 [iU]/mL | SolutionTopical | Baxter Healthcare Corporation | 0338-9564 |
| TISSEEL Fibrin Sealantfibrinogen human, human thrombin | Fibrinogen human 86.5 mg/mL; Human thrombin 500 [iU]/mL | SolutionTopical | Baxter Healthcare Corporation | 0338-9568 |