Prescription drug · ANDA
levoleucovorin NDC 68083-279
Levoleucovorin calcium 10 mg/mL · Injection · Intravenous · Gland Pharma Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68083-279-01 | 6808302790168083027901 | 1 VIAL in 1 CARTON (68083-279-01) / 25 mL in 1 VIALMarketed from Sep 20, 2018 |
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)
- levoleucovorin
- Generic name (nonproprietary)
- levoleucovorin
- Active ingredients
- Levoleucovorin calcium — 10 mg/mL
- Dosage form
- Injection
- Route
- Intravenous
- Labeler
- Gland Pharma LimitedNDC labeler code 68083
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 210892
- Marketing start
- Listing expires
- Other FDA classes
- Folic Acid (Chemical structure)
- Identifiers
- Product ID 68083-279_c3b9daf5-c553-46af-b651-841b43b2e706SPL ID c3b9daf5-c553-46af-b651-841b43b2e706SPL set ID dbb3613c-78a9-4a96-a766-17e7a9e8809bRxCUI 1720765UNII 778XL6VBS8UPC 0368083278014
- Pharmacologic class
- Folate Analog
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
N468083027901followed by a unit qualifier and the quantityPackage 68083-0279-01. 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)
Levoleucovorin injection is indicated for: rescue after high-dose methotrexate therapy in adult and pediatric patients with osteosarcoma. diminishing the toxicity associated with overdosage of folic acid antagonists or impaired methotrexate elimination in adult and pediatric patients. the treatment of adults with metastatic colorectal cancer in combination with fluorouracil. Limitations of Use Levoleucovorin injection is not indicated for pernicious anemia and megaloblastic anemia secondary to the lack of vitamin B 12 , because of the risk of progression of neurologic manifestations despite hematologic remission. Levoleucovorin injection is a folate analog indicated for: • Rescue after high-…
Excerpt only. Read the full label for complete information.
About NDC 68083-279
- What is NDC 68083-279?
- 68083-279 is the product NDC for levoleucovorin, Levoleucovorin calcium 10 mg/mL injection, listed with the FDA by Gland Pharma Limited. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- levoleucovorin.
- What is the active ingredient?
- Levoleucovorin calcium.
- 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 levoleucovorin?
- 6 other product NDCs are listed under this name. See all levoleucovorin NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other levoleucovorin products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Levoleucovorinlevoleucovorin calcium | Levoleucovorin calcium 50 mg/5mL | Injection, Powder, Lyophilized, For solutionIntravenous | Meitheal Pharmaceuticals Inc | 71288-104 | — |
| Levoleucovorinlevoleucovorin calcium | Levoleucovorin calcium 10 mg/mL | Injection, SolutionIntravenous | Meitheal Pharmaceuticals Inc. | 71288-105 | 71288-0105-1871288-0105-25 |
| Levoleucovorin | Levoleucovorin calcium 175 mg/17.5mL | Injection, SolutionIntravenous | Dr.Reddy's Laboratories Inc | 43598-771 | 43598-0771-11 |
| Levoleucovorin | Levoleucovorin calcium 250 mg/25mL | Injection, SolutionIntravenous | Dr.Reddy's Laboratories Inc | 43598-773 | 43598-0773-11 |
| levoleucovorin | Levoleucovorin calcium 10 mg/mL | InjectionIntravenous | Gland Pharma Limited | 68083-278 | 68083-0278-01 |
| Levoleucovorin | Levoleucovorin calcium 50 mg/5mL | Injection, Powder, Lyophilized, For solutionIntravenous | Hikma Pharmaceuticals USA Inc. | 0143-9558 | 00143-9558-01 |
Other NDCs under ANDA 210892
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 |
|---|---|---|---|---|
| Levoleucovorin | Levoleucovorin calcium 175 mg/17.5mL | Injection, SolutionIntravenous | Dr.Reddy's Laboratories Inc | 43598-771 |
| Levoleucovorin | Levoleucovorin calcium 250 mg/25mL | Injection, SolutionIntravenous | Dr.Reddy's Laboratories Inc | 43598-773 |
| levoleucovorin | Levoleucovorin calcium 10 mg/mL | InjectionIntravenous | Gland Pharma Limited | 68083-278 |