Prescription drug · NDA
Mesnex (Mesna) NDC 0338-1307
Mesna 100 mg/mL · Injection, Solution · Intravenous · Baxter Healthcare Company
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0338-1307-05 | 00338130705 | 1 VIAL in 1 BOX (0338-1307-05) / 10 mL in 1 VIAL (0338-1307-10)Marketed from Jul 18, 2018 |
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)
- Mesnex
- Generic name (nonproprietary)
- mesna
- Active ingredients
- Mesna — 100 mg/mL
- Dosage form
- Injection, Solution
- Route
- Intravenous
- Labeler
- Baxter Healthcare CompanyNDC labeler code 0338
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 019884
- Marketing start
- Listing expires
- Identifiers
- Product ID 0338-1307_b5528dda-de50-460a-aae4-2c586d0c2dbbSPL ID b5528dda-de50-460a-aae4-2c586d0c2dbbSPL set ID 2e8eebc3-ea75-4c57-bfe1-2c5dc2c37806RxCUI 204870, 899350UNII NR7O1405Q9
- Pharmacologic class
- Cytoprotective Agent
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.
- Administration
Drug administration (CPT 96360–96549)
When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.
- NDC on a medical claim
N400338130705followed by a unit qualifier and the quantityPackage 00338-1307-05. 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)
MESNEX is indicated as a prophylactic agent in reducing the incidence of ifosfamide-induced hemorrhagic cystitis. Limitation of Use: MESNEX is not indicated to reduce the risk of hematuria due to other pathological conditions such as thrombocytopenia. MESNEX is a cytoprotective agent indicated as a prophylactic agent in reducing the incidence of ifosfamide-induced hemorrhagic cystitis. (1) Limitation of Use: MESNEX is not indicated to reduce the risk of hematuria due to other pathological conditions such as thrombocytopenia. (1)
Excerpt only. Read the full label for complete information.
About NDC 0338-1307
- What is NDC 0338-1307?
- 0338-1307 is the product NDC for Mesnex (mesna), Mesna 100 mg/mL injection, solution, listed with the FDA by Baxter Healthcare Company. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Mesnex (Mesna).
- What is the active ingredient?
- Mesna.
- Who is the labeler?
- Baxter Healthcare Company, 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 Mesnex?
- 3 other product NDCs are listed under this name. See all Mesnex NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Mesnex products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Mesnexmesna | Mesna 400 mg/1 | Tablet, Film coatedOral | Baxter Healthcare Company | 67108-3565 | 67108-3565-09 |
| Mesnexmesna | Mesna 100 mg/mL | Injection, SolutionIntravenous | Baxter Healthcare Company | 0338-1305 | 00338-1305-0100338-1305-03 |
| Mesnexmesna | Mesna 100 mg/mL | Injection, SolutionIntravenous | Bamboo US Bidco LCC | 83703-559 | 83703-0559-0183703-0559-03 |
Other NDCs under NDA 019884
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 |
|---|---|---|---|---|
| Mesnexmesna | Mesna 100 mg/mL | Injection, SolutionIntravenous | Baxter Healthcare Company | 0338-1305 |
| Mesna | Mesna 100 mg/mL | Injection, SolutionIntravenous | Baxter Healthcare Company | 10019-951 |
| Mesnexmesna | Mesna 100 mg/mL | Injection, SolutionIntravenous | Bamboo US Bidco LCC | 83703-559 |
| Mesna | Mesna 100 mg/mL | Injection, SolutionIntravenous | Baxter Healthcare Company | 10019-953 |