What is NDC 76385-147?

76385-147 is the product NDC for Flecainide Acetate, Flecainide acetate 150 mg/1 tablet, listed with the FDA by UNICHEM PHARMACEUTICALS (USA), INC.. It has 2 package NDCs, shown above in 10- and 11-digit form.

UNICHEM PHARMACEUTICALS (USA), INC., NDC labeler code 76385. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Flecainide Acetate?

55 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Flecainide Acetate NDC 76385-147 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)76385-147Labeler and product segments. Claims need a package NDC.

Product NDC at billing width76385-0147Add 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
76385-147-01	7638501470176385014701	100 TABLET in 1 BOTTLE (76385-147-01)Marketed from Jan 15, 2024
76385-147-60	7638501476076385014760	60 TABLET in 1 BOTTLE (76385-147-60)Marketed from Jan 15, 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): Flecainide Acetate
Generic name (nonproprietary): flecainide acetate
Active ingredients: Flecainide acetate — 150 mg/1
Dosage form: Tablet
Route: Oral
Labeler: UNICHEM PHARMACEUTICALS (USA), INC.NDC labeler code 76385
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 210683
Marketing start: Jan 11, 2024
Listing expires: Dec 31, 2027
Identifiers: Product ID 76385-147_6e5f6cbe-c7eb-4168-b02b-119798e895d6SPL ID 6e5f6cbe-c7eb-4168-b02b-119798e895d6SPL set ID 5b33e96a-8336-46c4-aac7-4a6c0039cc80RxCUI 886662, 886666, 886671UNII M8U465Q1WQ
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

N476385014701 followed by a unit qualifier and the quantity

Package 76385-0147-01. 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 Jan 27, 2026. This label includes a boxed warning.

Indications (excerpt from the label)

INDICATIONS AND USAGE In patients without structural heart disease, flecainide acetate tablets, USP are indicated for the prevention of: •paroxysmal supraventricular tachycardias (PSVT), including atrioventricular nodal reentrant tachycardia, atrioventricular reentrant tachycardia and other supraventricular tachycardias of unspecified mechanism associated with disabling symptoms •paroxysmal atrial fibrillation/flutter (PAF) associated with disabling symptoms Flecainide acetate tablets, USP are also indicated for the prevention of: •Documented ventricular arrhythmias, such as sustained ventricular tachycardia (sustained VT), that in the judgment of the physician are life-threatening. Use of f…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 76385-147

What is NDC 76385-147?: 76385-147 is the product NDC for Flecainide Acetate, Flecainide acetate 150 mg/1 tablet, listed with the FDA by UNICHEM PHARMACEUTICALS (USA), INC.. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Flecainide Acetate.
What is the active ingredient?: Flecainide acetate.
Who is the labeler?: UNICHEM PHARMACEUTICALS (USA), INC., NDC labeler code 76385. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Flecainide Acetate?: 55 other product NDCs are listed under this name. See all Flecainide Acetate 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 Flecainide Acetate NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Flecainide Acetate	Flecainide acetate 100 mg/1	TabletOral	Bryant Ranch Prepack	71335-2577	71335-2577-0171335-2577-0271335-2577-03+2 more
Flecainide Acetate	Flecainide acetate 150 mg/1	TabletOral	Bryant Ranch Prepack	71335-2655	71335-2655-0171335-2655-0271335-2655-03+1 more
Flecainide Acetate	Flecainide acetate 100 mg/1	TabletOral	PD-Rx Pharmaceuticals, Inc.	72789-383	72789-0383-0172789-0383-6072789-0383-93
Flecainide Acetate	Flecainide acetate 150 mg/1	TabletOral	PD-Rx Pharmaceuticals, Inc.	72789-384	72789-0384-0172789-0384-6072789-0384-93
Flecainide Acetate	Flecainide acetate 50 mg/1	TabletOral	PD-Rx Pharmaceuticals, Inc.	72789-385	72789-0385-0172789-0385-6072789-0385-93
Flecainide Acetate	Flecainide acetate 50 mg/1	TabletOral	UNICHEM PHARMACEUTICALS (USA), INC.	76385-145	76385-0145-0176385-0145-60
Flecainide Acetate	Flecainide acetate 100 mg/1	TabletOral	UNICHEM PHARMACEUTICALS (USA), INC.	76385-146	76385-0146-0176385-0146-60
Flecainide Acetate	Flecainide acetate 50 mg/1	TabletOral	Epic Pharma, LLC	42806-817	42806-0817-01
Flecainide Acetate	Flecainide acetate 100 mg/1	TabletOral	Epic Pharma, LLC	42806-818	42806-0818-01
Flecainide Acetate	Flecainide acetate 150 mg/1	TabletOral	Epic Pharma, LLC	42806-819	42806-0819-01

All 56 Flecainide Acetate NDCs

Other NDCs under ANDA 210683

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

FDA NDC Directory listings under ANDA 210683
Product	Strength	Form · route	Labeler	Product NDC
Flecainide Acetate	Flecainide acetate 100 mg/1	TabletOral	Bryant Ranch Prepack	71335-2577
Flecainide Acetate	Flecainide acetate 150 mg/1	TabletOral	Bryant Ranch Prepack	71335-2655
Flecainide Acetate	Flecainide acetate 100 mg/1	TabletOral	PD-Rx Pharmaceuticals, Inc.	72789-383
Flecainide Acetate	Flecainide acetate 150 mg/1	TabletOral	PD-Rx Pharmaceuticals, Inc.	72789-384
Flecainide Acetate	Flecainide acetate 50 mg/1	TabletOral	PD-Rx Pharmaceuticals, Inc.	72789-385
Flecainide Acetate	Flecainide acetate 50 mg/1	TabletOral	UNICHEM PHARMACEUTICALS (USA), INC.	76385-145
Flecainide Acetate	Flecainide acetate 100 mg/1	TabletOral	UNICHEM PHARMACEUTICALS (USA), INC.	76385-146