What is NDC 76282-756?

76282-756 is the product NDC for Dofetilide, Dofetilide .25 mg/1 capsule, listed with the FDA by EXELAN PHARMACEUTICALS, INC.. It has 1 package NDC, shown above in 10- and 11-digit form.

EXELAN PHARMACEUTICALS, INC., NDC labeler code 76282. 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 76282-756 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)76282-756Labeler and product segments. Claims need a package NDC.

Product NDC at billing width76282-0756Add 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
76282-756-60	7628207566076282075660	60 CAPSULE in 1 BOTTLE (76282-756-60)Marketed from Nov 1, 2024

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 — .25 mg/1
Dosage form: Capsule
Route: Oral
Labeler: EXELAN PHARMACEUTICALS, INC.NDC labeler code 76282
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 212750
Marketing start: Nov 1, 2024
Listing expires: Dec 31, 2027
Identifiers: Product ID 76282-756_19f2a722-24ef-44f2-90e6-ec8df457baf6SPL ID 19f2a722-24ef-44f2-90e6-ec8df457baf6SPL set ID 41ccbb23-ae03-44bd-b438-0b0a8388d56bRxCUI 310003, 310004, 310005UNII R4Z9X1N2NDUPC 0376282756608, 0376282757605
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

N476282075660 followed by a unit qualifier and the quantity

Package 76282-0756-60. 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 Nov 13, 2024. 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 capsule is 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 capsule 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…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 76282-756

What is NDC 76282-756?: 76282-756 is the product NDC for Dofetilide, Dofetilide .25 mg/1 capsule, listed with the FDA by EXELAN PHARMACEUTICALS, INC.. 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?: EXELAN PHARMACEUTICALS, INC., NDC labeler code 76282. 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 .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 .5 mg/1	CapsuleOral	Dr. Reddy's Labratories Inc.	75907-054	75907-0054-60
Dofetilide	Dofetilide .25 mg/1	CapsuleOral	Dr. Reddy's Labratories Inc.	75907-055	75907-0055-60
Dofetilide	Dofetilide .125 mg/1	CapsuleOral	Dr. Reddy's Labratories Inc.	75907-056	75907-0056-60

All 32 Dofetilide NDCs

Other NDCs under ANDA 212750

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

FDA NDC Directory listings under ANDA 212750
Product	Strength	Form · route	Labeler	Product NDC
Dofetilide	Dofetilide .125 mg/1	CapsuleOral	EXELAN PHARMACEUTICALS, INC.	76282-755
Dofetilide	Dofetilide .5 mg/1	CapsuleOral	EXELAN PHARMACEUTICALS, INC.	76282-757
Dofetilide 0.125mg	Dofetilide .125 mg/1	CapsuleOral	Granules Pharmaceuticals Inc.	70010-024
Dofetilide 0.25mg	Dofetilide .25 mg/1	CapsuleOral	Granules Pharmaceuticals Inc.	70010-025
Dofetilide 0.5mg	Dofetilide .5 mg/1	CapsuleOral	Granules Pharmaceuticals Inc.	70010-026