Prescription drug · ANDA
Leucovorin Calcium NDC 50742-184
Leucovorin calcium 25 mg/1 · Tablet · Oral · Ingenus Pharmaceuticals, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50742-184-25 | 50742018425 | 25 TABLET in 1 BOTTLE (50742-184-25)Marketed from Jul 30, 2020 |
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 — 25 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Ingenus Pharmaceuticals, LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 211132
- Marketing start
- Listing expires
- Other FDA classes
- Folic Acid (Chemical structure)
- Identifiers
- Product ID 50742-184_93e939b7-2201-442a-a2be-7c5804f8be6fSPL ID 93e939b7-2201-442a-a2be-7c5804f8be6fSPL set ID 7409cdee-9093-47af-a4c4-2c55ce1b6361RxCUI 197860, 197861, 197862, 197863UNII RPR1R4C0P4UPC 0350742182244, 0350742182121, 0350742183241, 0350742184255, 0350742181308, 0350742181018
- 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 HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N450742018425followed by a unit qualifier and the quantityPackage 50742-0184-25. 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)
Leucovorin calcium tablets are a folate analog indicated: To reduce the toxicity of: Methotrexate in adult patients with impaired methotrexate elimination, and Folic acid antagonists or dihydrofolate reductase (DHFR) inhibitors following an overdose in adult patients. ( 1.1 ) For the treatment of cerebral folate transport deficiency in adult and pediatric patients who have a confirmed variant in the folate receptor 1 gene (FOLR1-CFTD). ( 1.2 ) Limitations of Use Leucovorin calcium tablets are not recommended for use in patients with a deficiency of methenyltetrahydrofolate synthetase (MTHFS) because MTHFS is a primary enzyme in the metabolism of leucovorin to 5-methenyltetrahydrofolate. ( 1.…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 211132
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 5 mg/1 | TabletOral | Ingenus Pharmaceuticals, LLC | 50742-181 |
| Leucovorin Calcium | Leucovorin calcium 10 mg/1 | TabletOral | Ingenus Pharmaceuticals, LLC | 50742-182 |
| Leucovorin Calcium | Leucovorin calcium 15 mg/1 | TabletOral | Ingenus Pharmaceuticals, LLC | 50742-183 |
| Leucovorin Calcium | Leucovorin calcium 25 mg/1 | TabletOral | Major Pharmaceuticals | 0904-7584 |