levoleucovorin NDC 68083-278

NDC codes

FDA NDC Directory

Product NDC (as listed)68083-278Labeler and product segments. Claims need a package NDC.

Product NDC at billing width68083-0278Add 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
68083-278-01	68083027801	1 VIAL in 1 CARTON (68083-278-01) / 17.5 mL in 1 VIALMarketed from Sep 20, 2018

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): levoleucovorin
Generic name (nonproprietary): levoleucovorin
Active ingredients: Levoleucovorin calcium — 10 mg/mL
Dosage form: Injection
Route: Intravenous
Labeler: Gland Pharma Limited
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 210892
Marketing start: Sep 20, 2018
Listing expires: Dec 31, 2026
Other FDA classes: Folic Acid (Chemical structure)
Identifiers: Product ID 68083-278_c3b9daf5-c553-46af-b651-841b43b2e706SPL ID c3b9daf5-c553-46af-b651-841b43b2e706SPL set ID dbb3613c-78a9-4a96-a766-17e7a9e8809bRxCUI 1720765UNII 778XL6VBS8UPC 0368083278014
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

N468083027801 followed by a unit qualifier and the quantity

Package 68083-0278-01. 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 Dec 1, 2020.

Indications (excerpt from the label)

Levoleucovorin injection is indicated for: rescue after high-dose methotrexate therapy in adult and pediatric patients with osteosarcoma. diminishing the toxicity associated with overdosage of folic acid antagonists or impaired methotrexate elimination in adult and pediatric patients. the treatment of adults with metastatic colorectal cancer in combination with fluorouracil. Limitations of Use Levoleucovorin injection is not indicated for pernicious anemia and megaloblastic anemia secondary to the lack of vitamin B 12 , because of the risk of progression of neurologic manifestations despite hematologic remission. Levoleucovorin injection is a folate analog indicated for: • Rescue after high-…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 210892

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

FDA NDC Directory listings under ANDA 210892
Product	Strength	Form · route	Labeler	Product NDC
Levoleucovorin	Levoleucovorin calcium 175 mg/17.5mL	Injection, SolutionIntravenous	Dr.Reddy's Laboratories Inc	43598-771
Levoleucovorin	Levoleucovorin calcium 250 mg/25mL	Injection, SolutionIntravenous	Dr.Reddy's Laboratories Inc	43598-773
levoleucovorin	Levoleucovorin calcium 10 mg/mL	InjectionIntravenous	Gland Pharma Limited	68083-279