What is NDC 70010-025?

70010-025 is the product NDC for Dofetilide 0.25mg, Dofetilide .25 mg/1 capsule, listed with the FDA by Granules Pharmaceuticals Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.

Granules Pharmaceuticals Inc., NDC labeler code 70010. 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 0.25mg?

None: this is the only finished product listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Dofetilide 0.25mg NDC 70010-025 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)70010-025Labeler and product segments. Claims need a package NDC.

Product NDC at billing width70010-0025Add 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
70010-025-06	7001000250670010002506	60 CAPSULE in 1 BOTTLE (70010-025-06)Marketed from Nov 14, 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 0.25mg
Generic name (nonproprietary): dofetilide 0.25mg
Active ingredients: Dofetilide — .25 mg/1
Dosage form: Capsule
Route: Oral
Labeler: Granules Pharmaceuticals Inc.NDC labeler code 70010
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 212750
Marketing start: Nov 14, 2024
Listing expires: Dec 31, 2027
Identifiers: Product ID 70010-025_5d4ea270-965c-73ef-e063-6394a90aa4a1SPL ID 5d4ea270-965c-73ef-e063-6394a90aa4a1
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

N470010002506 followed by a unit qualifier and the quantity

Package 70010-0025-06. 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

The FDA listing for this product does not reference a label (SPL) set.

About NDC 70010-025

What is NDC 70010-025?: 70010-025 is the product NDC for Dofetilide 0.25mg, Dofetilide .25 mg/1 capsule, listed with the FDA by Granules Pharmaceuticals Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Dofetilide 0.25mg.
What is the active ingredient?: Dofetilide.
Who is the labeler?: Granules Pharmaceuticals Inc., NDC labeler code 70010. 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 0.25mg?: None: this is the only finished product listed under this name.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

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 .25 mg/1	CapsuleOral	EXELAN PHARMACEUTICALS, INC.	76282-756
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 0.5mg	Dofetilide .5 mg/1	CapsuleOral	Granules Pharmaceuticals Inc.	70010-026