Prescription drug · ANDA
leucovorin calcium NDC 71288-163
Leucovorin calcium 350 mg/17.5mL · Injection, Powder, Lyophilized, For solution · Intramuscular, Intravenous · Meitheal Pharmaceuticals Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71288-163-30 | 71288016330 | 1 VIAL, SINGLE-DOSE in 1 CARTON (71288-163-30) / 17.5 mL in 1 VIAL, SINGLE-DOSEMarketed from Jul 19, 2023 |
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)
- leucovorin calcium
- Generic name (nonproprietary)
- leucovorin calcium
- Active ingredients
- Leucovorin calcium — 350 mg/17.5mL
- Dosage form
- Injection, Powder, Lyophilized, For solution
- Route
- Intramuscular, Intravenous
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 216590
- Marketing start
- Listing expires
- Other FDA classes
- Folic Acid (Chemical structure)
- Identifiers
- Product ID 71288-163_077a459b-e884-4452-aed3-0857a38ce26fSPL ID 077a459b-e884-4452-aed3-0857a38ce26fSPL set ID 9df20901-6980-4d4e-89ec-40f3c1f91852RxCUI 237788, 1803930, 1803932, 1803937, 2055036UNII RPR1R4C0P4
- 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
N471288016330followed by a unit qualifier and the quantityPackage 71288-0163-30. 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)
INDICATIONS AND USAGE Leucovorin Calcium for Injection rescue is indicated after high dose methotrexate therapy in osteosarcoma. Leucovorin Calcium for Injection is also indicated to diminish the toxicity and counteract the effects of impaired methotrexate elimination and of inadvertent overdosages of folic acid antagonists. Leucovorin Calcium for Injection is indicated in the treatment of megaloblastic anemias due to folic acid deficiency when oral therapy is not feasible. Leucovorin Calcium for Injection is also indicated for use in combination with 5-fluorouracil to prolong survival in the palliative treatment of patients with advanced colorectal cancer. Leucovorin Calcium for Injection s…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 216590
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 |
|---|---|---|---|---|
| leucovorin calcium | Leucovorin calcium 100 mg/10mL | Injection, Powder, Lyophilized, For solutionIntramuscular, Intravenous | BluePoint Laboratories | 68001-648 |
| leucovorin calcium | Leucovorin calcium 200 mg/20mL | Injection, Powder, Lyophilized, For solutionIntramuscular, Intravenous | BluePoint Laboratories | 68001-649 |
| leucovorin calcium | Leucovorin calcium 350 mg/17.5mL | Injection, Powder, Lyophilized, For solutionIntramuscular, Intravenous | BluePoint Laboratories | 68001-650 |
| leucovorin calcium | Leucovorin calcium 50 mg/5mL | Injection, Powder, Lyophilized, For solutionIntramuscular, Intravenous | Meitheal Pharmaceuticals Inc. | 71288-160 |
| leucovorin calcium | Leucovorin calcium 500 mg/50mL | Injection, Powder, Lyophilized, For solutionIntramuscular, Intravenous | Meitheal Pharmaceuticals Inc. | 71288-164 |
| leucovorin calcium | Leucovorin calcium 100 mg/10mL | Injection, Powder, Lyophilized, For solutionIntramuscular, Intravenous | Meitheal Pharmaceuticals Inc. | 71288-161 |
| leucovorin calcium | Leucovorin calcium 200 mg/20mL | Injection, Powder, Lyophilized, For solutionIntramuscular, Intravenous | Meitheal Pharmaceuticals Inc. | 71288-162 |