NDC codes

FDA NDC Directory
Product NDC (as listed)55154-8185Labeler and product segments. Claims need a package NDC.
Product NDC at billing width55154-8185Add 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
55154-8185-05515481850010 BLISTER PACK in 1 BAG (55154-8185-0) / 1 TABLET in 1 BLISTER PACKMarketed from Jun 15, 2019

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
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 55154-8185_b0c44872-a74d-4b1f-bd2b-71009f866985SPL ID b0c44872-a74d-4b1f-bd2b-71009f866985SPL set ID 0caedb97-56fd-4ec0-bfb2-c7683b8f5f1bRxCUI 833528UNII 976728SY6ZUPC 0055154818506
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

N455154818500 followed by a unit qualifier and the quantity

Package 55154-8185-00. 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

Label details couldn’t be retrieved right now. Open the label on DailyMed.

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/1TabletOralAmerican Health Packaging60687-437
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/1TabletOralREMEDYREPACK INC.70518-1939
Amiodarone HydrochlorideAmiodarone hydrochloride 200 mg/1TabletOralAurobindo Pharma Limited65862-732

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