NDC codes

FDA NDC Directory
Product NDC (as listed)70515-261Labeler and product segments. Claims need a package NDC.
Product NDC at billing width70515-0261Add 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 NDC11-digit (billing)PackageCopy
70515-261-107051502611010 VIAL in 1 BOX (70515-261-10) / 2 mL in 1 VIALMarketed from Oct 29, 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)
Lanoxin
Generic name (nonproprietary)
digoxin
Active ingredients
Digoxin — 250 ug/mL
Dosage form
Injection, Solution
Route
Intramuscular, Intravenous
Product type
Prescription drug
Marketing category
NDA — New Drug ApplicationApplication NDA 009330
Marketing start
Listing expires
Other FDA classes
Cardiac Glycosides (Chemical structure)
Identifiers
Product ID 70515-261_415f97e2-9ce0-b282-e063-6394a90ab0a8SPL ID 415f97e2-9ce0-b282-e063-6394a90ab0a8SPL set ID 9ec84cac-6ecc-43dc-8006-6ccc029e2707RxCUI 104208, 204504, 208135, 208137UNII 73K4184T59
Pharmacologic class
Cardiac Glycoside

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

N470515026110 followed by a unit qualifier and the quantity

Package 70515-0261-10. 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 .

Indications (excerpt from the label)

LANOXIN is a cardiac glycoside indicated for: Treatment of mild to moderate heart failure in adults. ( 1.1 ) Increasing myocardial contractility in pediatric patients with heart failure. ( 1.2 ) Control of resting ventricular rate in adults with chronic atrial fibrillation. ( 1.3 ) 1.1 Heart Failure in Adults LANOXIN is indicated for the treatment of mild to moderate heart failure in adults. LANOXIN increases left ventricular ejection fraction and improves heart failure symptoms, as evidenced by improved exercise capacity and decreased heart failure-related hospitalizations and emergency care, while having no effect on mortality. Where possible, LANOXIN should be used in combination with a d…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under NDA 009330

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

FDA NDC Directory listings under NDA 009330
ProductStrengthForm · routeLabelerProduct NDC
LanoxindigoxinDigoxin 250 ug/mLInjection, SolutionIntramuscular, IntravenousCovis Pharma US, Inc70515-260
LanoxindigoxinDigoxin 100 ug/mLInjection, SolutionIntramuscular, IntravenousCovis Pharma US, Inc70515-262
LanoxindigoxinDigoxin 100 ug/mLInjection, SolutionIntramuscular, IntravenousCovis Pharma US, Inc70515-263

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