NDC codes

FDA NDC Directory
Product NDC (as listed)59651-257Labeler and product segments. Claims need a package NDC.
Product NDC at billing width59651-0257Add 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 NDC11-digit (billing)PackageCopy
59651-257-015965102570159651025701100 TABLET, FILM COATED in 1 BOTTLE (59651-257-01)Marketed from Oct 25, 2019
59651-257-335965102573359651025733300 TABLET, FILM COATED in 1 BOTTLE (59651-257-33)Marketed from Oct 25, 2019

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 — 225 mg/1
Dosage form
Tablet, Film coated
Route
Oral
Labeler
Aurobindo Pharma LimitedNDC labeler code 59651
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 202445
Marketing start
Listing expires
Identifiers
Product ID 59651-257_b59b252f-8b73-4f72-8d01-4d2076c18fa6SPL ID b59b252f-8b73-4f72-8d01-4d2076c18fa6SPL set ID 0c887381-42fe-4f37-858a-d9ffb218dd1cRxCUI 861424, 861427, 861430UNII 33XCH0HOCD
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

N459651025701 followed by a unit qualifier and the quantity

Package 59651-0257-01. 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 . This label includes a boxed warning.

Indications (excerpt from the label)

Propafenone hydrochloride tablets are indicated to: prolong the time to recurrence of paroxysmal atrial fibrillation/flutter (PAF) associated with disabling symptoms in patients without structural heart disease. prolong the time to recurrence of paroxysmal supraventricular tachycardia (PSVT) associated with disabling symptoms in patients without structural heart disease. treat documented ventricular arrhythmias, such as sustained ventricular tachycardia that, in the judgment of the physician, are life-threatening. Initiate treatment in the hospital. Usage Considerations: The use of propafenone hydrochloride tablets in patients with permanent atrial fibrillation (AF) or in patients exclusivel…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 59651-257

What is NDC 59651-257?
59651-257 is the product NDC for Propafenone Hydrochloride, Propafenone hydrochloride 225 mg/1 tablet, film coated, 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?
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
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Propafenone HydrochloridePropafenone hydrochloride 150 mg/1Tablet, Film coatedOralAmerican Health Packaging60687-93060687-0930-01
Propafenone HydrochloridePropafenone hydrochloride 300 mg/1Tablet, Film coatedOralStrides Pharma Science Limited64380-24664380-0246-01
Propafenone HydrochloridePropafenone hydrochloride 225 mg/1Tablet, Film coatedOralStrides Pharma Science Limited64380-26864380-0268-0164380-0268-02
Propafenone HydrochloridePropafenone hydrochloride 150 mg/1Tablet, Film coatedOralStrides Pharma Science Limited64380-26964380-0269-0164380-0269-02
Propafenone HydrochloridePropafenone hydrochloride 225 mg/1Capsule, Extended releaseOralAurobindo Pharma Limited59651-27659651-0276-0559651-0276-6059651-0276-90
Propafenone HydrochloridePropafenone hydrochloride 325 mg/1Capsule, Extended releaseOralAurobindo Pharma Limited59651-27759651-0277-0559651-0277-6059651-0277-90
Propafenone HydrochloridePropafenone hydrochloride 425 mg/1Capsule, Extended releaseOralAurobindo Pharma Limited59651-27859651-0278-0559651-0278-6059651-0278-90
Propafenone HydrochloridePropafenone hydrochloride 150 mg/1Tablet, Film coatedOralAmerican Health Packaging60687-70960687-0709-01
Propafenone HydrochloridePropafenone hydrochloride 300 mg/1Tablet, Film coatedOralStrides Pharma Science Limited64380-16364380-0163-01
Propafenone HydrochloridePropafenone hydrochloride 225 mg/1Tablet, Film coatedOralStrides Pharma Science Limited64380-16464380-0164-0164380-0164-02

All 53 Propafenone Hydrochloride NDCs

Other NDCs under ANDA 202445

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

FDA NDC Directory listings under ANDA 202445
ProductStrengthForm · routeLabelerProduct NDC
Propafenone HydrochloridePropafenone hydrochloride 150 mg/1Tablet, Film coatedOralAurobindo Pharma Limited59651-256
Propafenone HydrochloridePropafenone hydrochloride 300 mg/1Tablet, Film coatedOralAurobindo Pharma Limited59651-258
Propafenone HydrochloridePropafenone hydrochloride 150 mg/1Tablet, Film coatedOralBryant Ranch Prepack72162-2616
Propafenone HydrochloridePropafenone hydrochloride 225 mg/1Tablet, Film coatedOralBryant Ranch Prepack72162-2617
Propafenone HydrochloridePropafenone hydrochloride 300 mg/1Tablet, Film coatedOralBryant Ranch Prepack72162-2618

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