Prescription drug · ANDA
Leucovorin Calcium NDC 0555-0484
Leucovorin calcium 5 mg/1 · Tablet · Oral · Teva Pharmaceuticals USA, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0555-0484-01 | 0055504840100555048401 | 30 TABLET in 1 BOTTLE (0555-0484-01)Marketed from Jun 30, 1990 | |
| 0555-0484-02 | 0055504840200555048402 | 100 TABLET in 1 BOTTLE (0555-0484-02)Marketed from Jun 30, 1990 |
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 — 5 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Teva Pharmaceuticals USA, Inc.NDC labeler code 0555
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 071198
- Marketing start
- Listing expires
- Other FDA classes
- Folic Acid (Chemical structure)
- Identifiers
- Product ID 0555-0484_3ba61b64-dd4e-44d7-8348-85a193c7c267SPL ID 3ba61b64-dd4e-44d7-8348-85a193c7c267SPL set ID 94669fc8-3c1c-4228-be27-09a1cd468c36RxCUI 197862, 197863UNII RPR1R4C0P4UPC 0305550484011
- 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
N400555048401followed by a unit qualifier and the quantityPackage 00555-0484-01. 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)
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.
About NDC 0555-0484
- What is NDC 0555-0484?
- 0555-0484 is the product NDC for Leucovorin Calcium, Leucovorin calcium 5 mg/1 tablet, listed with the FDA by Teva Pharmaceuticals USA, Inc.. 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?
- Teva Pharmaceuticals USA, Inc., NDC labeler code 0555. 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 |