Prescription drug · ANDA
Mesna (Mesna injection) NDC 68083-161
Mesna 100 mg/mL · Solution · Intravenous · Gland Pharma Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68083-161-01 | 68083016101 | 1 VIAL, MULTI-DOSE in 1 CARTON (68083-161-01) / 10 mL in 1 VIAL, MULTI-DOSEMarketed from Dec 20, 2017 | |
| 68083-161-10 | 68083016110 | 10 VIAL, MULTI-DOSE in 1 CARTON (68083-161-10) / 10 mL in 1 VIAL, MULTI-DOSEMarketed from Dec 20, 2017 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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)
- Mesna
- Generic name (nonproprietary)
- mesna injection
- Active ingredients
- Mesna — 100 mg/mL
- Dosage form
- Solution
- Route
- Intravenous
- Labeler
- Gland Pharma LimitedNDC labeler code 68083
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 206992
- Marketing start
- Listing expires
- Identifiers
- Product ID 68083-161_b61d560c-02fd-4ae7-a6f7-fa7edb0a0d3fSPL ID b61d560c-02fd-4ae7-a6f7-fa7edb0a0d3fSPL set ID a7af968c-05cf-4438-94ba-96a2baf9c367RxCUI 204870UNII NR7O1405Q9UPC 0368083161019
- 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
N468083016101followed by a unit qualifier and the quantityPackage 68083-0161-01. 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)
Mesna Injection is indicated as a prophylactic agent in reducing the incidence of ifosfamide-induced hemorrhagic cystitis. Limitation of Use : Mesna Injection is not indicated to reduce the risk of hematuria due to other pathological conditions such as thrombocytopenia. Mesna Injection is a cytoprotective agent indicated as a prophylactic agent in reducing the incidence of ifosfamide-induced hemorrhagic cystitis. (1) Limitation of Use : Mesna Injection 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 68083-161
- What is NDC 68083-161?
- 68083-161 is the product NDC for Mesna (mesna injection), Mesna 100 mg/mL solution, listed with the FDA by Gland Pharma Limited. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Mesna (Mesna Injection).
- What is the active ingredient?
- Mesna.
- Who is the labeler?
- Gland Pharma Limited, NDC labeler code 68083. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Mesna?
- 7 other product NDCs are listed under this name. See all Mesna NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Mesna products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Mesna | Mesna 100 mg/mL | Injection, SolutionIntravenous | Eugia US LLC | 55150-520 | 55150-0520-01 |
| Mesna | Mesna 400 mg/1 | Tablet, Film coatedOral | Ingenus Pharmaceuticals, LLC | 50742-354 | 50742-0354-01 |
| Mesna | Mesna 100 mg/mL | Injection, SolutionIntravenous | Sagent Pharmaceuticals | 25021-201 | 25021-0201-1025021-0201-11 |
| mesna | Mesna 100 mg/mL | Injection, SolutionIntravenous | Hikma Pharmaceuticals USA Inc. | 0143-9260 | 00143-9260-01 |
| Mesna | Mesna 100 mg/mL | Injection, SolutionIntravenous | Fresenius Kabi USA, LLC | 63323-733 | 63323-0733-1063323-0733-11 |
| Mesna | Mesna 100 mg/mL | Injection, SolutionIntravenous | Baxter Healthcare Company | 10019-951 | 10019-0951-05 |
| Mesna | Mesna 100 mg/mL | Injection, SolutionIntravenous | Baxter Healthcare Company | 10019-953 | 10019-0953-0110019-0953-02 |