Prescription drug · ANDA
Levoleucovorin (Levoleucovorin calcium) NDC 71288-104
Levoleucovorin calcium 50 mg/5mL · Injection, Powder, Lyophilized, For solution · Intravenous · Meitheal Pharmaceuticals Inc
NDC codes
FDA NDC DirectoryProduct information
- Brand name (proprietary)
- Levoleucovorin
- Generic name (nonproprietary)
- levoleucovorin calcium
- Active ingredients
- Levoleucovorin calcium — 50 mg/5mL
- Dosage form
- Injection, Powder, Lyophilized, For solution
- Route
- Intravenous
- Labeler
- Meitheal Pharmaceuticals IncNDC labeler code 71288
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 211003
- Marketing start
- Listing expires
- Other FDA classes
- Folic Acid (Chemical structure)
- Identifiers
- Product ID 71288-104_a0d839ca-80eb-4061-a0c4-30e5d94af094SPL ID a0d839ca-80eb-4061-a0c4-30e5d94af094SPL set ID b4dd0e14-d42a-4581-b1f0-7ba95b50bca6RxCUI 1720760UNII 778XL6VBS8
- 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.
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
Levoleucovorin for 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. Levoleucovorin for Injection is a folate analog indicated for: Rescue after high-dose methotrexate therapy in adult and pediatric patients with osteosarcoma. ( 1 ) Diminishing the toxicity associated with overdosage of folic acid antagonists or impaired methotrexate elimination in adult and pediatric patients. ( 1 ) …
Excerpt only. Read the full label for complete information.
About NDC 71288-104
- What is NDC 71288-104?
- 71288-104 is the product NDC for Levoleucovorin (levoleucovorin calcium), Levoleucovorin calcium 50 mg/5mL injection, powder, lyophilized, for solution, listed with the FDA by Meitheal Pharmaceuticals Inc.
- What drug is associated with this NDC?
- Levoleucovorin (Levoleucovorin calcium).
- What is the active ingredient?
- Levoleucovorin calcium.
- Who is the labeler?
- Meitheal Pharmaceuticals Inc, NDC labeler code 71288. 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 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 10 mg/mL | InjectionIntravenous | Gland Pharma Limited | 68083-279 | 68083-0279-01 |
| Levoleucovorin | Levoleucovorin calcium 50 mg/5mL | Injection, Powder, Lyophilized, For solutionIntravenous | Hikma Pharmaceuticals USA Inc. | 0143-9558 | 00143-9558-01 |