NDC codes

FDA NDC Directory
Product NDC (as listed)65862-732Labeler and product segments. Claims need a package NDC.
Product NDC at billing width65862-0732Add 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
65862-732-016586207320165862073201100 TABLET in 1 BOTTLE (65862-732-01)Marketed from Jun 3, 2016
65862-732-056586207320565862073205500 TABLET in 1 BOTTLE (65862-732-05)Marketed from Jun 3, 2016
65862-732-256586207322565862073225250 TABLET in 1 BOTTLE (65862-732-25)Marketed from Jun 3, 2016
65862-732-30658620732306586207323030 TABLET in 1 BOTTLE (65862-732-30)Marketed from Jun 3, 2016
65862-732-60658620732606586207326060 TABLET in 1 BOTTLE (65862-732-60)Marketed from Jun 3, 2016
65862-732-90658620732906586207329090 TABLET in 1 BOTTLE (65862-732-90)Marketed from Jun 3, 2016
65862-732-9965862073299658620732991000 TABLET in 1 BOTTLE (65862-732-99)Marketed from Jun 3, 2016

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)
Amiodarone Hydrochloride
Generic name (nonproprietary)
amiodarone hydrochloride
Active ingredients
Amiodarone hydrochloride — 200 mg/1
Dosage form
Tablet
Route
Oral
Labeler
Aurobindo Pharma LimitedNDC labeler code 65862
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 204742
Marketing start
Listing expires
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 65862-732_84ad18a0-1887-4b62-8ac1-94ace3433366SPL ID 84ad18a0-1887-4b62-8ac1-94ace3433366SPL set ID 7ae393d1-7469-432a-9f21-f5ebab1207d1RxCUI 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

N465862073201 followed by a unit qualifier and the quantity

Package 65862-0732-01. 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)

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 is 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 65862-732

What is NDC 65862-732?
65862-732 is the product NDC for Amiodarone Hydrochloride, Amiodarone hydrochloride 200 mg/1 tablet, listed with the FDA by Aurobindo Pharma Limited. It has 7 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?
Aurobindo Pharma Limited, NDC labeler code 65862. 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
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
amiodarone hydrochlorideAmiodarone hydrochloride 200 mg/1TabletOralSafecor Health LLC48433-15448433-0154-20
Amiodarone HydrochlorideAmiodarone hydrochloride 200 mg/1TabletOralMajor Pharmaceuticals0904-757600904-7576-61
Amiodarone HydrochlorideAmiodarone hydrochloride 50 mg/mLInjection, SolutionIntravenousHenry Schein, Inc.0404-977200404-9772-03
Amiodarone HydrochlorideAmiodarone hydrochloride 50 mg/mLInjection, SolutionIntravenousFresenius Kabi USA, LLC65219-64365219-0643-03
Amiodarone HydrochlorideAmiodarone hydrochloride 50 mg/mLInjection, SolutionIntravenousFresenius Kabi USA, LLC65219-64565219-0645-09
Amiodarone HydrochlorideAmiodarone hydrochloride 50 mg/mLInjection, SolutionIntravenousMedical Purchasing Solutions, LLC.71872-735471872-7354-01
Amiodarone HydrochlorideAmiodarone hydrochloride 50 mg/mLInjection, SolutionIntravenousSlate Run Pharmaceuticals70436-23270436-0232-5070436-0232-5270436-0232-62
Amiodarone HydrochlorideAmiodarone hydrochloride 100 mg/1TabletOralDr. Reddy's Labratories Inc.75907-00575907-0005-30
Amiodarone HydrochlorideAmiodarone hydrochloride 200 mg/1TabletOralDr. Reddy's Labratories Inc.75907-00675907-0006-60
Amiodarone HydrochlorideAmiodarone hydrochloride 50 mg/mLInjection, SolutionIntravenousMylan Institutional LLC72078-04672078-0046-0972078-0046-18

All 62 Amiodarone Hydrochloride NDCs

Other NDCs under ANDA 204742

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

FDA NDC Directory listings under ANDA 204742
ProductStrengthForm · routeLabelerProduct NDC
Amiodarone HydrochlorideAmiodarone hydrochloride 200 mg/1TabletOralNCS HealthCare of KY, LLC dba Vangard Labs0615-8258
Amiodarone HydrochlorideAmiodarone hydrochloride 200 mg/1TabletOralA-S Medication Solutions50090-3015
Amiodarone HydrochlorideAmiodarone hydrochloride 200 mg/1TabletOralCardinal Health 107, LLC55154-8185
Amiodarone HydrochlorideAmiodarone hydrochloride 200 mg/1TabletOralAmerican Health Packaging60687-437
Amiodarone HydrochlorideAmiodarone hydrochloride 200 mg/1TabletOralREMEDYREPACK INC.70518-1939

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