NDC codes

FDA NDC Directory
Product NDC (as listed)48433-154Labeler and product segments. Claims need a package NDC.
Product NDC at billing width48433-0154Add 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
48433-154-204843301542048433015420100 BLISTER PACK in 1 CARTON (48433-154-20) / 1 TABLET in 1 BLISTER PACK (48433-154-01)Marketed from Jun 1, 2026

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
Safecor Health LLCNDC labeler code 48433
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 079029
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 48433-154_544f49d5-053a-73e8-e063-6394a90ada25SPL ID 544f49d5-053a-73e8-e063-6394a90ada25SPL set ID f49d011f-5ca6-4f75-ba16-2099fe42f5aaRxCUI 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

N448433015420 followed by a unit qualifier and the quantity

Package 48433-0154-20. 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 tablet 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 48433-154

What is NDC 48433-154?
48433-154 is the product NDC for amiodarone hydrochloride, Amiodarone hydrochloride 200 mg/1 tablet, listed with the FDA by Safecor Health LLC. It has 1 package NDC, 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?
Safecor Health LLC, NDC labeler code 48433. 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/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
amiodarone hydrochlorideAmiodarone hydrochloride 100 mg/1TabletOralZydus Pharmaceuticals USA Inc.68382-29768382-0297-06

All 62 amiodarone hydrochloride NDCs

Other NDCs under ANDA 079029

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

FDA NDC Directory listings under ANDA 079029
ProductStrengthForm · routeLabelerProduct NDC
Amiodarone hydrochlorideAmiodarone hydrochloride 200 mg/1TabletOralZydus Lifesciences Limited65841-631
Amiodarone hydrochlorideAmiodarone hydrochloride 100 mg/1TabletOralZydus Lifesciences Limited65841-840
Amiodarone hydrochlorideAmiodarone hydrochloride 400 mg/1TabletOralZydus Lifesciences Limited65841-841
amiodarone hydrochlorideAmiodarone hydrochloride 200 mg/1TabletOralZydus Pharmaceuticals USA Inc.68382-227
amiodarone hydrochlorideAmiodarone hydrochloride 100 mg/1TabletOralZydus Pharmaceuticals USA Inc.68382-297
amiodarone hydrochlorideAmiodarone hydrochloride 400 mg/1TabletOralZydus Pharmaceuticals USA Inc.68382-298

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