Prescription drug · ANDA
Leucovorin Calcium NDC 42806-358
Leucovorin calcium 5 mg/1 · Tablet · Oral · Epic Pharma LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 42806-358-01 | 4280603580142806035801 | 100 TABLET in 1 BOTTLE (42806-358-01)Marketed from Apr 16, 2020 | |
| 42806-358-30 | 4280603583042806035830 | 30 TABLET in 1 BOTTLE (42806-358-30)Marketed from Apr 16, 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 — 5 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Epic Pharma LLCNDC labeler code 42806
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 074544
- Marketing start
- Listing expires
- Other FDA classes
- Folic Acid (Chemical structure)
- Identifiers
- Product ID 42806-358_9db189e6-7ecc-465c-8197-c454350a45dcSPL ID 9db189e6-7ecc-465c-8197-c454350a45dcSPL set ID 2627a485-05b5-4dab-ac20-dc840e5c469dRxCUI 197860, 197861, 197862, 197863UNII RPR1R4C0P4UPC 0342806133217, 0342806359259, 0342806134245, 0342806358016
- 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
N442806035801followed by a unit qualifier and the quantityPackage 42806-0358-01. 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)
INDICATIONS AND USAGE Leucovorin calcium tablets are indicated to diminish the toxicity and counteract the effects of impaired methotrexate elimination and of inadvertent overdosages of folic acid antagonists.
Excerpt only. Read the full label for complete information.
About NDC 42806-358
- What is NDC 42806-358?
- 42806-358 is the product NDC for Leucovorin Calcium, Leucovorin calcium 5 mg/1 tablet, listed with the FDA by Epic Pharma LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Leucovorin Calcium.
- What is the active ingredient?
- Leucovorin calcium.
- Who is the labeler?
- Epic Pharma LLC, NDC labeler code 42806. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Leucovorin Calcium?
- 54 other product NDCs are listed under this name. See all Leucovorin Calcium NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Leucovorin Calcium products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Leucovorin Calcium | Leucovorin calcium 25 mg/1 | TabletOral | Major Pharmaceuticals | 0904-7584 | 00904-7584-10 |
| Leucovorin Calcium | Leucovorin calcium 350 mg/17.5mL | Injection, Powder, Lyophilized, For solutionIntramuscular, Intravenous | Gland Pharma Limited | 68083-587 | 68083-0587-01 |
| Leucovorin Calcium | Leucovorin calcium 350 mg/17.5mL | Injection, Powder, Lyophilized, For solutionIntramuscular, Intravenous | GLENMARK PHARMACEUTICALS INC., USA | 68462-767 | 68462-0767-35 |
| leucovorin calcium | Leucovorin calcium 100 mg/10mL | Injection, Powder, Lyophilized, For solutionIntramuscular, Intravenous | BluePoint Laboratories | 68001-648 | 68001-0648-36 |
| leucovorin calcium | Leucovorin calcium 200 mg/20mL | Injection, Powder, Lyophilized, For solutionIntramuscular, Intravenous | BluePoint Laboratories | 68001-649 | 68001-0649-37 |
| leucovorin calcium | Leucovorin calcium 350 mg/17.5mL | Injection, Powder, Lyophilized, For solutionIntramuscular, Intravenous | BluePoint Laboratories | 68001-650 | 68001-0650-38 |
| Leucovorin Calcium | Leucovorin calcium 350 mg/1 | Injection, Powder, Lyophilized, For solutionIntramuscular, Intravenous | Slate Run Pharmaceuticals, LLC | 70436-119 | 70436-0119-80 |
| leucovorin calcium | Leucovorin calcium 50 mg/5mL | Injection, Powder, Lyophilized, For solutionIntramuscular, Intravenous | Meitheal Pharmaceuticals Inc. | 71288-160 | 71288-0160-10 |
| leucovorin calcium | Leucovorin calcium 100 mg/10mL | Injection, Powder, Lyophilized, For solutionIntramuscular, Intravenous | Meitheal Pharmaceuticals Inc. | 71288-161 | 71288-0161-20 |
| leucovorin calcium | Leucovorin calcium 200 mg/20mL | Injection, Powder, Lyophilized, For solutionIntramuscular, Intravenous | Meitheal Pharmaceuticals Inc. | 71288-162 | 71288-0162-30 |
Other NDCs under ANDA 074544
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 10 mg/1 | TabletOral | Epic Pharma LLC | 42806-133 |
| Leucovorin Calcium | Leucovorin calcium 15 mg/1 | TabletOral | Epic Pharma LLC | 42806-134 |
| Leucovorin Calcium | Leucovorin calcium 25 mg/1 | TabletOral | Epic Pharma LLC | 42806-359 |