Prescription drug · ANDA
Levoleucovorin NDC 43598-771
Levoleucovorin calcium 175 mg/17.5mL · Injection, Solution · Intravenous · Dr.Reddy's Laboratories Inc
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 43598-771-11 | 4359807711143598077111 | 1 VIAL, SINGLE-DOSE in 1 CARTON (43598-771-11) / 17.5 mL in 1 VIAL, SINGLE-DOSEMarketed from Sep 26, 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 — 175 mg/17.5mL
- Dosage form
- Injection, Solution
- Route
- Intravenous
- Labeler
- Dr.Reddy's Laboratories IncNDC labeler code 43598
- 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 43598-771_2f5844a8-825f-6a4f-996e-17e21c369359SPL ID 2f5844a8-825f-6a4f-996e-17e21c369359SPL set ID c003aaed-89c3-d6a6-0d34-18851b7e1255RxCUI 1720765, 1720773UNII 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.
- NDC on a medical claim
N443598077111followed by a unit qualifier and the quantityPackage 43598-0771-11. 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 a folate analog. Levoleucovorin injection rescue is indicated after high-dose methotrexate therapy in osteosarcoma. Levoleucovorin injection is also indicated to diminish the toxicity and counteract the effects of impaired methotrexate elimination and of inadvertent overdosage of folic acid antagonists. Levoleucovorin injection is indicated for use in combination chemotherapy with 5-fluorouracil in the palliative treatment of patients with advanced metastatic colorectal cancer. Levoleucovor injection is a folate analog indicated for: · Rescue after high-dose methotrexate therapy in osteosarcoma. · Diminishing the toxicity and counteracting the effects of impaired …
Excerpt only. Read the full label for complete information.
About NDC 43598-771
- What is NDC 43598-771?
- 43598-771 is the product NDC for Levoleucovorin, Levoleucovorin calcium 175 mg/17.5mL injection, solution, listed with the FDA by Dr.Reddy's Laboratories Inc. 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?
- Dr.Reddy's Laboratories Inc, NDC labeler code 43598. 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 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 |
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 250 mg/25mL | Injection, SolutionIntravenous | Dr.Reddy's Laboratories Inc | 43598-773 |
| levoleucovorin | Levoleucovorin calcium 10 mg/mL | InjectionIntravenous | Gland Pharma Limited | 68083-278 |
| levoleucovorin | Levoleucovorin calcium 10 mg/mL | InjectionIntravenous | Gland Pharma Limited | 68083-279 |