Prescription drug · ANDA
Leucovorin Calcium NDC 0143-9554
Leucovorin calcium 100 mg/10mL · Injection, Powder, Lyophilized, For solution · Intramuscular, Intravenous · Hikma Pharmaceuticals USA Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0143-9554-01 | 0014395540100143955401 | 1 VIAL in 1 BOX (0143-9554-01) / 10 mL in 1 VIALMarketed from Mar 28, 1988 |
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 — 100 mg/10mL
- Dosage form
- Injection, Powder, Lyophilized, For solution
- Route
- Intramuscular, Intravenous
- Labeler
- Hikma Pharmaceuticals USA Inc.NDC labeler code 0143
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 089717
- Marketing start
- Listing expires
- Other FDA classes
- Folic Acid (Chemical structure)
- Identifiers
- Product ID 0143-9554_e2d1484b-2920-45ab-9207-4caa5285fef4SPL ID e2d1484b-2920-45ab-9207-4caa5285fef4SPL set ID cc52077f-5663-4f79-a273-0aecf655e038RxCUI 237788, 1803930, 1803932, 1803937UNII 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 drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.
- Administration
Drug administration (CPT 96360–96549)
When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.
- NDC on a medical claim
N400143955401followed by a unit qualifier and the quantityPackage 00143-9554-01. 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, USP rescue is indicated after high dose methotrexate therapy in osteosarcoma. Leucovorin Calcium, USP is also indicated to diminish the toxicity and counteract the effects of impaired methotrexate elimination and of inadvertent overdosages of folic acid antagonists. Leucovorin Calcium, USP is indicated in the treatment of megaloblastic anemias due to folic acid deficiency when oral therapy is not feasible. Leucovorin Calcium, USP is also indicated for use in combination with 5-fluorouracil to prolong survival in the palliative treatment of patients with advanced colorectal cancer. Leucovorin should not be mixed in the same infusion as 5-fluorouracil …
Excerpt only. Read the full label for complete information.
About NDC 0143-9554
- What is NDC 0143-9554?
- 0143-9554 is the product NDC for Leucovorin Calcium, Leucovorin calcium 100 mg/10mL injection, powder, lyophilized, for solution, listed with the FDA by Hikma Pharmaceuticals USA Inc.. 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?
- Hikma Pharmaceuticals USA Inc., NDC labeler code 0143. 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 089717
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 100 mg/10mL | Injection, Powder, Lyophilized, For solutionIntramuscular, Intravenous | BluePoint Laboratories | 68001-416 |