What is NDC 42794-046?

42794-046 is the product NDC for Dofetilide, Dofetilide 500 ug/1 capsule, listed with the FDA by Sigmapharm Laboratories, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.

Sigmapharm Laboratories, LLC, NDC labeler code 42794. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Dofetilide?

31 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Dofetilide NDC 42794-046 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)42794-046Labeler and product segments. Claims need a package NDC.

Product NDC at billing width42794-0046Add 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
42794-046-10	42794004610	60 CAPSULE in 1 BOTTLE, PLASTIC (42794-046-10)Marketed from Jun 11, 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): Dofetilide
Generic name (nonproprietary): dofetilide
Active ingredients: Dofetilide — 500 ug/1
Dosage form: Capsule
Route: Oral
Labeler: Sigmapharm Laboratories, LLCNDC labeler code 42794
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 207746
Marketing start: Jun 11, 2018
Listing expires: Dec 31, 2026
Identifiers: Product ID 42794-046_f1f1f93d-aee6-246f-e053-2a95a90a9eeeSPL ID f1f1f93d-aee6-246f-e053-2a95a90a9eeeSPL set ID 0cb2ef7d-e35b-483b-9985-cfef99d7b96fRxCUI 310003, 310004, 310005UNII R4Z9X1N2NDUPC 0342794044106, 0342794045103, 0342794046100
Pharmacologic class: Antiarrhythmic

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

N442794004610 followed by a unit qualifier and the quantity

Package 42794-0046-10. 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 Jan 10, 2023. This label includes a boxed warning.

Indications (excerpt from the label)

INDICATIONS AND USAGE Maintenance of Normal Sinus Rhythm (Delay in AF/AFl Recurrence) Dofetilide capsules are indicated for the maintenance of normal sinus rhythm (delay in time to recurrence of atrial fibrillation/atrial flutter [AF/AFl]) in patients with atrial fibrillation/atrial flutter of greater than one week duration who have been converted to normal sinus rhythm. Because dofetilide can cause life threatening ventricular arrhythmias, it should be reserved for patients in whom atrial fibrillation/atrial flutter is highly symptomatic. In general, antiarrhythmic therapy for atrial fibrillation/atrial flutter aims to prolong the time in normal sinus rhythm. Recurrence is expected in some …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 42794-046

What is NDC 42794-046?: 42794-046 is the product NDC for Dofetilide, Dofetilide 500 ug/1 capsule, listed with the FDA by Sigmapharm Laboratories, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Dofetilide.
What is the active ingredient?: Dofetilide.
Who is the labeler?: Sigmapharm Laboratories, LLC, NDC labeler code 42794. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Dofetilide?: 31 other product NDCs are listed under this name. See all Dofetilide 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 Dofetilide NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Dofetilide	Dofetilide .125 mg/1	CapsuleOral	REMEDYREPACK INC.	70518-4738	70518-4738-0070518-4738-01
Dofetilide	Dofetilide .25 mg/1	CapsuleOral	REMEDYREPACK INC.	70518-4617	70518-4617-00
Dofetilide	Dofetilide .125 mg/1	CapsuleOral	EXELAN PHARMACEUTICALS, INC.	76282-755	76282-0755-60
Dofetilide	Dofetilide .25 mg/1	CapsuleOral	EXELAN PHARMACEUTICALS, INC.	76282-756	76282-0756-60
Dofetilide	Dofetilide .5 mg/1	CapsuleOral	EXELAN PHARMACEUTICALS, INC.	76282-757	76282-0757-60
Dofetilide	Dofetilide .125 mg/1	CapsuleOral	Major Pharmaceuticals	0904-7522	00904-7522-08
Dofetilide	Dofetilide .25 mg/1	CapsuleOral	Major Pharmaceuticals	0904-7523	00904-7523-08
Dofetilide	Dofetilide .5 mg/1	CapsuleOral	Major Pharmaceuticals	0904-7524	00904-7524-08
Dofetilide	Dofetilide .25 mg/1	CapsuleOral	Dr. Reddy's Labratories Inc.	75907-055	75907-0055-60
Dofetilide	Dofetilide .5 mg/1	CapsuleOral	Dr. Reddy's Labratories Inc.	75907-054	75907-0054-60

All 32 Dofetilide NDCs

Other NDCs under ANDA 207746

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

FDA NDC Directory listings under ANDA 207746
Product	Strength	Form · route	Labeler	Product NDC
Dofetilide	Dofetilide 250 ug/1	CapsuleOral	Sigmapharm Laboratories, LLC	42794-045
Dofetilide	Dofetilide 125 ug/1	CapsuleOral	Sigmapharm Laboratories, LLC	42794-044