What is NDC 71335-0881?

71335-0881 is the product NDC for Amiodarone Hydrochloride, Amiodarone hydrochloride 200 mg/1 tablet, listed with the FDA by Bryant Ranch Prepack. It has 5 package NDCs, shown above in 10- and 11-digit form.

Bryant Ranch Prepack, NDC labeler code 71335. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Amiodarone Hydrochloride?

61 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Amiodarone Hydrochloride NDC 71335-0881

NDC codes

FDA NDC Directory

Product NDC (as listed)71335-0881Labeler and product segments. Claims need a package NDC.

Product NDC at billing width71335-0881Add 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
71335-0881-1	71335088101	200 TABLET in 1 BOTTLE (71335-0881-1)Marketed from Dec 27, 2021
71335-0881-2	71335088102	30 TABLET in 1 BOTTLE (71335-0881-2)Marketed from Jan 3, 2019
71335-0881-3	71335088103	60 TABLET in 1 BOTTLE (71335-0881-3)Marketed from Dec 27, 2021
71335-0881-4	71335088104	90 TABLET in 1 BOTTLE (71335-0881-4)Marketed from Jun 26, 2018
71335-0881-5	71335088105	10 TABLET in 1 BOTTLE (71335-0881-5)Marketed from Dec 27, 2021

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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): Amiodarone Hydrochloride
Generic name (nonproprietary): amiodarone hydrochloride
Active ingredients: Amiodarone hydrochloride — 200 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Bryant Ranch PrepackNDC labeler code 71335
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 075424
Marketing start: Mar 30, 2001
Listing expires: Dec 31, 2027
Other FDA classes: Cytochrome P450 1A2 Inhibitors (Mechanism)Cytochrome P450 2C9 Inhibitors (Mechanism)Cytochrome P450 2D6 Inhibitors (Mechanism)Cytochrome P450 3A Inhibitors (Mechanism)P-Glycoprotein Inhibitors (Mechanism)
Identifiers: Product ID 71335-0881_2404aeca-2635-45e6-a839-578734efb312SPL ID 2404aeca-2635-45e6-a839-578734efb312SPL set ID f3e631c5-1204-419c-8dbe-fa9b37a77f97RxCUI 833528UNII 976728SY6Z
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

N471335088101 followed by a unit qualifier and the quantity

Package 71335-0881-01. 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 Jun 4, 2026. This label includes a boxed warning.

Indications (excerpt from the label)

Amiodarone hydrochloride tablets are indicated for the treatment of documented, life-threatening recurrent ventricular fibrillation and life-threatening recurrent hemodynamically unstable tachycardia in adults who have not responded to adequate doses of other available antiarrhythmics or when alternative agents cannot be tolerated. Amiodarone hydrochloride tablets are an antiarrhythmic indicated for: Recurrent ventricular fibrillation. ( 1 ) Recurrent hemodynamically unstable ventricular tachycardia. ( 1 )

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 71335-0881

What is NDC 71335-0881?: 71335-0881 is the product NDC for Amiodarone Hydrochloride, Amiodarone hydrochloride 200 mg/1 tablet, listed with the FDA by Bryant Ranch Prepack. It has 5 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Amiodarone Hydrochloride.
What is the active ingredient?: Amiodarone hydrochloride.
Who is the labeler?: Bryant Ranch Prepack, NDC labeler code 71335. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Amiodarone Hydrochloride?: 61 other product NDCs are listed under this name. See all Amiodarone 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 Amiodarone Hydrochloride NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
amiodarone hydrochloride	Amiodarone hydrochloride 200 mg/1	TabletOral	Safecor Health LLC	48433-154	48433-0154-20
Amiodarone Hydrochloride	Amiodarone hydrochloride 200 mg/1	TabletOral	Major Pharmaceuticals	0904-7576	00904-7576-61
Amiodarone Hydrochloride	Amiodarone hydrochloride 50 mg/mL	Injection, SolutionIntravenous	Henry Schein, Inc.	0404-9772	00404-9772-03
Amiodarone Hydrochloride	Amiodarone hydrochloride 50 mg/mL	Injection, SolutionIntravenous	Fresenius Kabi USA, LLC	65219-643	65219-0643-03
Amiodarone Hydrochloride	Amiodarone hydrochloride 50 mg/mL	Injection, SolutionIntravenous	Fresenius Kabi USA, LLC	65219-645	65219-0645-09
Amiodarone Hydrochloride	Amiodarone hydrochloride 50 mg/mL	Injection, SolutionIntravenous	Slate Run Pharmaceuticals	70436-232	70436-0232-5070436-0232-5270436-0232-62
Amiodarone Hydrochloride	Amiodarone hydrochloride 50 mg/mL	Injection, SolutionIntravenous	Medical Purchasing Solutions, LLC.	71872-7354	71872-7354-01
Amiodarone Hydrochloride	Amiodarone hydrochloride 100 mg/1	TabletOral	Dr. Reddy's Labratories Inc.	75907-005	75907-0005-30
Amiodarone Hydrochloride	Amiodarone hydrochloride 200 mg/1	TabletOral	Dr. Reddy's Labratories Inc.	75907-006	75907-0006-60
Amiodarone Hydrochloride	Amiodarone hydrochloride 50 mg/mL	Injection, SolutionIntravenous	Mylan Institutional LLC	72078-046	72078-0046-0972078-0046-18

All 62 Amiodarone Hydrochloride NDCs

Other NDCs under ANDA 075424

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

FDA NDC Directory listings under ANDA 075424
Product	Strength	Form · route	Labeler	Product NDC
Amiodarone Hydrochloride	Amiodarone hydrochloride 200 mg/1	TabletOral	Major Pharmaceuticals	0904-6993
Amiodarone Hydrochloride	Amiodarone hydrochloride 200 mg/1	TabletOral	Sun Pharmaceutical Industries, Inc.	51672-4025
Amiodarone Hydrochloride	Amiodarone hydrochloride 100 mg/1	TabletOral	Sun Pharmaceutical Industries, Inc.	51672-4055
Amiodarone Hydrochloride	Amiodarone hydrochloride 200 mg/1	TabletOral	Cardinal Health 107, LLC	55154-3365