Prescription drug · ANDA
Leucovorin Calcium NDC 0904-7584
Leucovorin calcium 25 mg/1 · Tablet · Oral · Major Pharmaceuticals
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0904-7584-10 | 0090475841000904758410 | 20 BLISTER PACK in 1 CARTON (0904-7584-10) / 1 TABLET in 1 BLISTER PACKMarketed from Mar 27, 2026 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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
- Major PharmaceuticalsNDC labeler code 0904
- 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 0904-7584_273407f5-0be2-435a-b7a8-f21be8ffbb3cSPL ID 273407f5-0be2-435a-b7a8-f21be8ffbb3cSPL set ID 273407f5-0be2-435a-b7a8-f21be8ffbb3cRxCUI 197862UNII 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 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
N400904758410followed by a unit qualifier and the quantityPackage 00904-7584-10. 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 is 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 0904-7584
- What is NDC 0904-7584?
- 0904-7584 is the product NDC for Leucovorin Calcium, Leucovorin calcium 25 mg/1 tablet, listed with the FDA by Major Pharmaceuticals. It has 1 package NDC, 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?
- Major Pharmaceuticals, NDC labeler code 0904. 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 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 |
| leucovorin calcium | Leucovorin calcium 350 mg/17.5mL | Injection, Powder, Lyophilized, For solutionIntramuscular, Intravenous | Meitheal Pharmaceuticals Inc. | 71288-163 | 71288-0163-30 |
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 | Ingenus Pharmaceuticals, LLC | 50742-184 |