What is NDC 67457-528?

67457-528 is the product NDC for Leucovorin Calcium, Leucovorin calcium 100 mg/10mL injection, powder, lyophilized, for suspension, listed with the FDA by Mylan Institutional LLC. It has 1 package NDC, shown above in 10- and 11-digit form.

Mylan Institutional LLC, NDC labeler code 67457. 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 67457-528 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)67457-528Labeler and product segments. Claims need a package NDC.

Product NDC at billing width67457-0528Add 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
67457-528-10	6745705281067457052810	1 VIAL, SINGLE-DOSE in 1 CARTON (67457-528-10) / 10 mL in 1 VIAL, SINGLE-DOSEMarketed from Jul 23, 2019

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 — 100 mg/10mL
Dosage form: Injection, Powder, Lyophilized, For suspension
Route: Intramuscular, Intravenous
Labeler: Mylan Institutional LLCNDC labeler code 67457
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 203800
Marketing start: Jul 23, 2019
Listing expires: Dec 31, 2027
Other FDA classes: Folic Acid (Chemical structure)
Identifiers: Product ID 67457-528_2890b03c-dbef-4db8-8b07-c042d7765677SPL ID 2890b03c-dbef-4db8-8b07-c042d7765677SPL set ID 1cb701ca-2478-4268-9d69-80293965d59dRxCUI 237788, 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.

How CPT relates to drug billing

NDC on a medical claim

N467457052810 followed by a unit qualifier and the quantity

Package 67457-0528-10. 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 Jun 1, 2022.

Indications (excerpt from the label)

INDICATIONS AND USAGE Leucovorin calcium rescue is indicated after high dose methotrexate therapy in osteosarcoma. Leucovorin calcium is also indicated to diminish the toxicity and counteract the effects of impaired methotrexate elimination and of inadvertent over dosages of folic acid antagonists. Leucovorin calcium is indicated in the treatment of megaloblastic anemias due to folic acid deficiency when oral therapy is not feasible. Leucovorin 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 because a precipitate may f…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 67457-528

What is NDC 67457-528?: 67457-528 is the product NDC for Leucovorin Calcium, Leucovorin calcium 100 mg/10mL injection, powder, lyophilized, for suspension, listed with the FDA by Mylan Institutional 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?: Mylan Institutional LLC, NDC labeler code 67457. 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 203800

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

FDA NDC Directory listings under ANDA 203800
Product	Strength	Form · route	Labeler	Product NDC
Leucovorin Calcium	Leucovorin calcium 200 mg/20mL	Injection, Powder, Lyophilized, For suspensionIntramuscular, Intravenous	Mylan Institutional LLC	67457-529
Leucovorin Calcium	Leucovorin calcium 350 mg/17.5mL	Injection, Powder, Lyophilized, For suspensionIntramuscular, Intravenous	Mylan Institutional LLC	67457-530