Leucovorin Calcium NDC 0054-4496

NDC codes

FDA NDC Directory

Product NDC (as listed)0054-4496Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00054-4496Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
0054-4496-13	00054449613	30 TABLET in 1 BOTTLE (0054-4496-13)Marketed from Mar 22, 1993
0054-4496-25	00054449625	100 TABLET in 1 BOTTLE (0054-4496-25)Marketed from Mar 22, 1993

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: Hikma Pharmaceuticals USA Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 072733
Marketing start: Feb 22, 1993
Listing expires: Dec 31, 2027
Other FDA classes: Folic Acid (Chemical structure)
Identifiers: Product ID 0054-4496_3ea4147c-f529-42ad-8672-4d36ab4c2b37SPL ID 3ea4147c-f529-42ad-8672-4d36ab4c2b37SPL set ID 33663425-4731-4977-9127-9e59b6b91497RxCUI 197860, 197861, 197862, 197863UNII RPR1R4C0P4UPC 0300544498104, 0300544499118, 0300544497053
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

N400054449613 followed by a unit qualifier and the quantity

Package 00054-4496-13. 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 Mar 10, 2026.

Indications (excerpt from the label)

Leucovorin is a folate analog indicated: • To reduce the toxicity of: o Methotrexate in adult patients with impaired methotrexate elimination, and o 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 is 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. ( 1.2 ) Limitations of Use Leu…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 072733

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 072733
Product	Strength	Form · route	Labeler	Product NDC
Leucovorin Calcium	Leucovorin calcium 5 mg/1	TabletOral	Hikma Pharmaceuticals USA Inc.	0054-8496