What is NDC 69315-186?

69315-186 is the product NDC for Leucovorin Calcium, Leucovorin calcium 15 mg/1 tablet, listed with the FDA by Leading Pharma, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.

Leading Pharma, LLC, NDC labeler code 69315. 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.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Leucovorin Calcium NDC 69315-186 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)69315-186Labeler and product segments. Claims need a package NDC.

Product NDC at billing width69315-0186Add 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
69315-186-24	6931501862469315018624	24 TABLET in 1 BOTTLE (69315-186-24)Marketed from Nov 16, 2020

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 — 15 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Leading Pharma, LLCNDC labeler code 69315
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 213929
Marketing start: Nov 16, 2020
Listing expires: Dec 31, 2027
Other FDA classes: Folic Acid (Chemical structure)
Identifiers: Product ID 69315-186_b7876a82-b489-48c3-92a5-15a0e30935f4SPL ID b7876a82-b489-48c3-92a5-15a0e30935f4SPL set ID c8102043-79f2-421a-b849-94bac19007a6RxCUI 197860, 197861, 197862, 197863UNII 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

N469315018624 followed by a unit qualifier and the quantity

Package 69315-0186-24. 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 27, 2026.

Indications (excerpt from the label)

Leucovorin is 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 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 Leucovorin is not…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 69315-186

What is NDC 69315-186?: 69315-186 is the product NDC for Leucovorin Calcium, Leucovorin calcium 15 mg/1 tablet, listed with the FDA by Leading Pharma, LLC. 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?: Leading Pharma, LLC, NDC labeler code 69315. 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.

Other finished products listed under the same name: strengths, forms and labelers.

Other Leucovorin Calcium NDCs
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

All 55 Leucovorin Calcium NDCs

Other NDCs under ANDA 213929

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

FDA NDC Directory listings under ANDA 213929
Product	Strength	Form · route	Labeler	Product NDC
Leucovorin Calcium	Leucovorin calcium 5 mg/1	TabletOral	Leading Pharma, LLC	69315-184
Leucovorin Calcium	Leucovorin calcium 10 mg/1	TabletOral	Leading Pharma, LLC	69315-185
Leucovorin Calcium	Leucovorin calcium 25 mg/1	TabletOral	Leading Pharma, LLC	69315-187
Leucovorin Calcium	Leucovorin calcium 5 mg/1	TabletOral	Proficient Rx LP	71205-908