Prescription drug · BLA
Recothrom (Thrombin topical recombinant) NDC 0338-0330
Kit · Baxter Healthcare Corporation
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0338-0330-01 | 00338033001 | 1 KIT in 1 KIT (0338-0330-01) * 20 mL in 1 VIAL (0338-0328-01) * 20 mL in 1 VIALMarketed from Jun 9, 2008 |
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)
- Recothrom
- Generic name (nonproprietary)
- thrombin topical recombinant
- Dosage form
- Kit
- Labeler
- Baxter Healthcare CorporationNDC labeler code 0338
- Product type
- Prescription drug
- Marketing category
- BLA — Biologics License ApplicationApplication BLA 125248
- Marketing start
- Listing expires
- Identifiers
- Product ID 0338-0330_dfa7d1e1-447c-44fb-bcbe-7e01a0c08297SPL ID dfa7d1e1-447c-44fb-bcbe-7e01a0c08297SPL set ID 54885644-e51e-4263-aadb-366abaeb56a3RxCUI 1367418, 1367420
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
N400338033001followed by a unit qualifier and the quantityPackage 00338-0330-01. 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
Current FDA label (SPL), effective .
Indications (excerpt from the label)
RECOTHROM Thrombin topical (Recombinant), is a topical thrombin indicated to aid hemostasis whenever oozing blood and minor bleeding from capillaries and small venules is accessible and control of bleeding by standard surgical techniques (such as suture, ligature, or cautery) is ineffective or impractical in adults and pediatric populations greater than or equal to one month of age. RECOTHROM may be used in conjunction with an absorbable gelatin sponge, USP. RECOTHROM Thrombin topical (Recombinant), is a topical thrombin indicated to aid hemostasis whenever oozing blood and minor bleeding from capillaries and small venules is accessible and control of bleeding by standard surgical techniques…
Excerpt only. Read the full label for complete information.
About NDC 0338-0330
- What is NDC 0338-0330?
- 0338-0330 is the product NDC for Recothrom (thrombin topical recombinant) 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?
- Recothrom (Thrombin topical recombinant).
- 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 Recothrom?
- 2 other product NDCs are listed under this name. See all Recothrom NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Recothrom products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Recothromthrombin topical recombinant | — | Kit | Baxter Healthcare Corporation | 0338-0326 | 00338-0326-01 |
| Recothromthrombin topical recombinant | — | Kit | Baxter Healthcare Corporation | 0338-0322 | 00338-0322-01 |
Other NDCs under BLA 125248
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 |
|---|---|---|---|---|
| Recothromthrombin topical recombinant | — | Kit | Baxter Healthcare Corporation | 0338-0322 |
| Recothromthrombin topical recombinant | — | Kit | Baxter Healthcare Corporation | 0338-0326 |