NDC codes

FDA NDC Directory
Product NDC (as listed)0781-3059Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00781-3059Add 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
0781-3059-95007813059950078130599510 AMPULE in 1 CARTON (0781-3059-95) / 2 mL in 1 AMPULE (0781-3059-72)Marketed from Aug 21, 2003

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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)
Digoxin
Generic name (nonproprietary)
digoxin
Active ingredients
Digoxin — 250 ug/mL
Dosage form
Injection, Solution
Route
Intramuscular, Intravenous, Parenteral
Labeler
Sandoz IncNDC labeler code 0781
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 040481
Marketing start
Listing expires
Other FDA classes
Cardiac Glycosides (Chemical structure)
Identifiers
Product ID 0781-3059_62ffbb27-b026-4fb2-b2a1-5c170036b8cfSPL ID 62ffbb27-b026-4fb2-b2a1-5c170036b8cfSPL set ID 58f45aba-ff6f-43cc-bb88-be40a9f7bedaRxCUI 104208UNII 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

N400781305995 followed by a unit qualifier and the quantity

Package 00781-3059-95. 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)

Digoxin injection 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 Digoxin injection is indicated for the treatment of mild to moderate heart failure in adults. Digoxin injection 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, digoxin in…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0781-3059

What is NDC 0781-3059?
0781-3059 is the product NDC for Digoxin, Digoxin 250 ug/mL injection, solution, listed with the FDA by Sandoz Inc. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Digoxin.
What is the active ingredient?
Digoxin.
Who is the labeler?
Sandoz Inc, NDC labeler code 0781. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Digoxin?
50 other product NDCs are listed under this name. See all Digoxin 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 Digoxin NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
DigoxinDigoxin .125 mg/1TabletOralCoupler LLC67046-131767046-1317-03
DigoxinDigoxin .25 mg/1TabletOralAmerican Health Packaging60687-86960687-0869-01
DigoxinDigoxin .125 mg/1TabletOralAmerican Health Packaging60687-85860687-0858-01
DigoxinDigoxin .125 mg/1TabletOralAvPAK50268-23850268-0238-15
DigoxinDigoxin .125 mg/1TabletOralREMEDYREPACK INC.70518-385970518-3859-00
DigoxinDigoxin .25 mg/1TabletOralREMEDYREPACK INC.70518-386070518-3860-00
DigoxinDigoxin .125 mg/1TabletOralNorthwind Health Company, LLC51655-40351655-0403-52
DigoxinDigoxin 125 ug/1TabletOralBryant Ranch Prepack71335-246371335-2463-0171335-2463-02
DigoxinDigoxin 250 ug/1TabletOralBryant Ranch Prepack71335-246471335-2464-0171335-2464-02
DigoxinDigoxin 250 ug/1TabletOralBryant Ranch Prepack71335-315671335-3156-0171335-3156-0271335-3156-03+1 more

All 51 Digoxin NDCs

Other NDCs under ANDA 040481

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

FDA NDC Directory listings under ANDA 040481
ProductStrengthForm · routeLabelerProduct NDC
DigoxinDigoxin 250 ug/mLInjection, SolutionIntramuscular, Intravenous, ParenteralMedical Purchasing Solutions, LLC71872-7325

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