Leucovorin Calcium NDC 70436-116

NDC codes

FDA NDC Directory

Product NDC (as listed)70436-116Labeler and product segments. Claims need a package NDC.

Product NDC at billing width70436-0116Add 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
70436-116-82	70436011682	10 VIAL in 1 BOX (70436-116-82) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL (70436-116-80)Marketed from Jul 10, 2023

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 — 50 mg/1
Dosage form: Injection, Powder, Lyophilized, For solution
Route: Intramuscular, Intravenous
Labeler: Slate Run Pharmaceuticals, LLC
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 217021
Marketing start: Jul 10, 2023
Listing expires: Dec 31, 2026
Other FDA classes: Folic Acid (Chemical structure)
Identifiers: Product ID 70436-116_2a4aaed3-885e-bc10-e063-6294a90a61afSPL ID 2a4aaed3-885e-bc10-e063-6294a90a61afSPL set ID d8bdd60c-9a1c-4ef4-ba6b-b911849128f1RxCUI 237788, 1803930, 1803932, 1803937, 2055036UNII 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

N470436011682 followed by a unit qualifier and the quantity

Package 70436-0116-82. 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 Dec 27, 2024.

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 overdosages 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 fo…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 217021

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

FDA NDC Directory listings under ANDA 217021
Product	Strength	Form · route	Labeler	Product NDC
Leucovorin Calcium	Leucovorin calcium 350 mg/1	Injection, Powder, Lyophilized, For solutionIntramuscular, Intravenous	Slate Run Pharmaceuticals, LLC	70436-119
Leucovorin Calcium	Leucovorin calcium 100 mg/1	Injection, Powder, Lyophilized, For solutionIntramuscular, Intravenous	Slate Run Pharmaceuticals, LLC	70436-117
Leucovorin Calcium	Leucovorin calcium 200 mg/1	Injection, Powder, Lyophilized, For solutionIntramuscular, Intravenous	Slate Run Pharmaceuticals, LLC	70436-118
Leucovorin Calcium	Leucovorin calcium 500 mg/1	Injection, Powder, Lyophilized, For solutionIntramuscular, Intravenous	Slate Run Pharmaceuticals, LLC	70436-120