NDC codes

FDA NDC Directory
Product NDC (as listed)51672-4056Labeler and product segments. Claims need a package NDC.
Product NDC at billing width51672-4056Add 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
51672-4056-151672405601100 TABLET in 1 BOTTLE (51672-4056-1)Marketed from Dec 2, 2003
51672-4056-3516724056031000 TABLET in 1 BOTTLE (51672-4056-3)Marketed from Dec 2, 2003
51672-4056-65167240560630 TABLET in 1 BOTTLE (51672-4056-6)Marketed from Dec 2, 2003

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 — 300 mg/1
Dosage form
Tablet
Route
Oral
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 076362
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 51672-4056_4cc4c3cb-aced-a125-e063-6394a90aee93SPL ID 4cc4c3cb-aced-a125-e063-6394a90aee93SPL set ID 7ccd3733-c3af-4a11-8500-0f99194c1472RxCUI 833528, 834348, 835956, 835960UNII 976728SY6ZUPC 0351672405663, 0351672405762, 0351672405564
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

N451672405601 followed by a unit qualifier and the quantity

Package 51672-4056-01. 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 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)

Other NDCs under ANDA 076362

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

FDA NDC Directory listings under ANDA 076362
ProductStrengthForm · routeLabelerProduct NDC
Amiodarone HydrochlorideAmiodarone hydrochloride 400 mg/1TabletOralSun Pharmaceutical Industries, Inc.51672-4057

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