What is NDC 59651-278?

59651-278 is the product NDC for Propafenone Hydrochloride, Propafenone hydrochloride 425 mg/1 capsule, extended release, listed with the FDA by Aurobindo Pharma Limited. It has 3 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 Propafenone Hydrochloride?

52 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Propafenone Hydrochloride NDC 59651-278

NDC codes

FDA NDC Directory

Product NDC (as listed)59651-278Labeler and product segments. Claims need a package NDC.

Product NDC at billing width59651-0278Add 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
59651-278-05	5965102780559651027805	500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (59651-278-05)Marketed from Feb 21, 2023
59651-278-60	5965102786059651027860	60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (59651-278-60)Marketed from Feb 21, 2023
59651-278-90	5965102789059651027890	90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (59651-278-90)Marketed from Feb 21, 2023

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): Propafenone Hydrochloride
Generic name (nonproprietary): propafenone hydrochloride
Active ingredients: Propafenone hydrochloride — 425 mg/1
Dosage form: Capsule, Extended release
Route: Oral
Labeler: Aurobindo Pharma LimitedNDC labeler code 59651
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 213096
Marketing start: Feb 21, 2023
Listing expires: Dec 31, 2027
Identifiers: Product ID 59651-278_ef0c975d-08ee-4649-9017-4f7f1a2981a1SPL ID ef0c975d-08ee-4649-9017-4f7f1a2981a1SPL set ID 1c4fc726-3f5b-4b12-a66e-727c5133d1d9RxCUI 861156, 861164, 861171UNII 33XCH0HOCDUPC 0359651278604
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

N459651027805 followed by a unit qualifier and the quantity

Package 59651-0278-05. 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 Feb 4, 2025. This label includes a boxed warning.

Indications (excerpt from the label)

Propafenone hydrochloride extended-release capsules are indicated to prolong the time to recurrence of symptomatic atrial fibrillation (AF) in patients with episodic (most likely paroxysmal or persistent) AF who do not have structural heart disease. Usage Considerations: The use of propafenone hydrochloride extended-release capsules in patients with permanent AF or in patients exclusively with atrial flutter or paroxysmal supraventricular tachycardia (PSVT) has not been evaluated. Do not use propafenone hydrochloride extended-release capsules to control ventricular rate during AF. Some patients with atrial flutter treated with propafenone have developed 1:1 conduction, producing an increase …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 59651-278

What is NDC 59651-278?: 59651-278 is the product NDC for Propafenone Hydrochloride, Propafenone hydrochloride 425 mg/1 capsule, extended release, listed with the FDA by Aurobindo Pharma Limited. It has 3 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Propafenone Hydrochloride.
What is the active ingredient?: Propafenone hydrochloride.
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 Propafenone Hydrochloride?: 52 other product NDCs are listed under this name. See all Propafenone Hydrochloride 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 Propafenone Hydrochloride NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Propafenone Hydrochloride	Propafenone hydrochloride 150 mg/1	Tablet, Film coatedOral	American Health Packaging	60687-930	60687-0930-01
Propafenone Hydrochloride	Propafenone hydrochloride 300 mg/1	Tablet, Film coatedOral	Strides Pharma Science Limited	64380-246	64380-0246-01
Propafenone Hydrochloride	Propafenone hydrochloride 225 mg/1	Tablet, Film coatedOral	Strides Pharma Science Limited	64380-268	64380-0268-0164380-0268-02
Propafenone Hydrochloride	Propafenone hydrochloride 150 mg/1	Tablet, Film coatedOral	Strides Pharma Science Limited	64380-269	64380-0269-0164380-0269-02
Propafenone Hydrochloride	Propafenone hydrochloride 225 mg/1	Capsule, Extended releaseOral	Aurobindo Pharma Limited	59651-276	59651-0276-0559651-0276-6059651-0276-90
Propafenone Hydrochloride	Propafenone hydrochloride 325 mg/1	Capsule, Extended releaseOral	Aurobindo Pharma Limited	59651-277	59651-0277-0559651-0277-6059651-0277-90
Propafenone Hydrochloride	Propafenone hydrochloride 150 mg/1	Tablet, Film coatedOral	American Health Packaging	60687-709	60687-0709-01
Propafenone Hydrochloride	Propafenone hydrochloride 300 mg/1	Tablet, Film coatedOral	Strides Pharma Science Limited	64380-163	64380-0163-01
Propafenone Hydrochloride	Propafenone hydrochloride 225 mg/1	Tablet, Film coatedOral	Strides Pharma Science Limited	64380-164	64380-0164-0164380-0164-02
Propafenone Hydrochloride	Propafenone hydrochloride 150 mg/1	Tablet, Film coatedOral	Strides Pharma Science Limited	64380-165	64380-0165-0164380-0165-02

All 53 Propafenone Hydrochloride NDCs

Other NDCs under ANDA 213096

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

FDA NDC Directory listings under ANDA 213096
Product	Strength	Form · route	Labeler	Product NDC
Propafenone Hydrochloride	Propafenone hydrochloride 225 mg/1	Capsule, Extended releaseOral	Aurobindo Pharma Limited	59651-276
Propafenone Hydrochloride	Propafenone hydrochloride 325 mg/1	Capsule, Extended releaseOral	Aurobindo Pharma Limited	59651-277