What is NDC 59651-438?

59651-438 is the product NDC for Digoxin, Digoxin .25 mg/1 tablet, listed with the FDA by Aurobindo Pharma Limited. It has 2 package NDCs, shown above in 10- and 11-digit form.

Aurobindo Pharma Limited, NDC labeler code 59651. 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.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Digoxin NDC 59651-438 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)59651-438Labeler and product segments. Claims need a package NDC.

Product NDC at billing width59651-0438Add 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
59651-438-01	5965104380159651043801	100 TABLET in 1 BOTTLE (59651-438-01)Marketed from Feb 8, 2022
59651-438-99	5965104389959651043899	1000 TABLET in 1 BOTTLE (59651-438-99)Marketed from Feb 8, 2022

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): Digoxin
Generic name (nonproprietary): digoxin
Active ingredients: Digoxin — .25 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Aurobindo Pharma LimitedNDC labeler code 59651
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 214982
Marketing start: Feb 8, 2022
Listing expires: Dec 31, 2027
Other FDA classes: Cardiac Glycosides (Chemical structure)
Identifiers: Product ID 59651-438_1338ce78-5a23-4dd2-bb1b-335f35cb2646SPL ID 1338ce78-5a23-4dd2-bb1b-335f35cb2646SPL set ID 2bcd56ee-4497-4b8d-84db-a1470c77827bRxCUI 197604, 197606, 245273UNII 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 HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N459651043801 followed by a unit qualifier and the quantity

Package 59651-0438-01. 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 May 15, 2024.

Indications (excerpt from the label)

Digoxin 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 patients with chronic atrial fibrillation in adults. ( 1.3 ) 1.1 Heart Failure in Adults Digoxin tablets are indicated for the treatment of mild to moderate heart failure in adults. Digoxin tablets 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 tablets sh…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 59651-438

What is NDC 59651-438?: 59651-438 is the product NDC for Digoxin, Digoxin .25 mg/1 tablet, listed with the FDA by Aurobindo Pharma Limited. It has 2 package NDCs, 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?: Aurobindo Pharma Limited, NDC labeler code 59651. 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
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Digoxin	Digoxin .125 mg/1	TabletOral	Coupler LLC	67046-1317	67046-1317-03
Digoxin	Digoxin .25 mg/1	TabletOral	American Health Packaging	60687-869	60687-0869-01
Digoxin	Digoxin .125 mg/1	TabletOral	American Health Packaging	60687-858	60687-0858-01
Digoxin	Digoxin .125 mg/1	TabletOral	AvPAK	50268-238	50268-0238-15
Digoxin	Digoxin .125 mg/1	TabletOral	REMEDYREPACK INC.	70518-3859	70518-3859-00
Digoxin	Digoxin .25 mg/1	TabletOral	REMEDYREPACK INC.	70518-3860	70518-3860-00
Digoxin	Digoxin .125 mg/1	TabletOral	Northwind Health Company, LLC	51655-403	51655-0403-52
Digoxin	Digoxin 125 ug/1	TabletOral	Bryant Ranch Prepack	71335-2463	71335-2463-0171335-2463-02
Digoxin	Digoxin 250 ug/1	TabletOral	Bryant Ranch Prepack	71335-2464	71335-2464-0171335-2464-02
Digoxin	Digoxin 250 ug/1	TabletOral	Bryant Ranch Prepack	71335-3156	71335-3156-0171335-3156-0271335-3156-03+1 more

All 51 Digoxin NDCs

Other NDCs under ANDA 214982

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

FDA NDC Directory listings under ANDA 214982
Product	Strength	Form · route	Labeler	Product NDC
Digoxin	Digoxin .125 mg/1	TabletOral	A-S Medication Solutions	50090-6708
Digoxin	Digoxin .25 mg/1	TabletOral	A-S Medication Solutions	50090-7865
Digoxin	Digoxin .125 mg/1	TabletOral	AvPAK	50268-238
Digoxin	Digoxin .0625 mg/1	TabletOral	Aurobindo Pharma Limited	59651-436
Digoxin	Digoxin .125 mg/1	TabletOral	Aurobindo Pharma Limited	59651-437
Digoxin	Digoxin .125 mg/1	TabletOral	Coupler LLC	67046-1317
Digoxin	Digoxin .125 mg/1	TabletOral	REMEDYREPACK INC.	70518-3859
Digoxin	Digoxin .25 mg/1	TabletOral	REMEDYREPACK INC.	70518-3860