Prescription drug · ANDA
Leucovorin Calcium NDC 42806-133
Leucovorin calcium 10 mg/1 · Tablet · Oral · Epic Pharma LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 42806-133-21 | 42806013321 | 12 TABLET in 1 BOTTLE (42806-133-21)Marketed from Jan 1, 2021 | |
| 42806-133-24 | 42806013324 | 24 TABLET in 1 BOTTLE (42806-133-24)Marketed from Jan 1, 2021 |
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 — 10 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Epic Pharma LLC
- 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 42806-133_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
N442806013321followed by a unit qualifier and the quantityPackage 42806-0133-21. 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.
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 15 mg/1 | TabletOral | Epic Pharma LLC | 42806-134 |
| Leucovorin Calcium | Leucovorin calcium 5 mg/1 | TabletOral | Epic Pharma LLC | 42806-358 |
| Leucovorin Calcium | Leucovorin calcium 25 mg/1 | TabletOral | Epic Pharma LLC | 42806-359 |