Amiodarone Hydrochloride NDC 75907-005

NDC codes

FDA NDC Directory

Product NDC (as listed)75907-005Labeler and product segments. Claims need a package NDC.

Product NDC at billing width75907-0005Add 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	Copy
75907-005-30	75907000530	30 TABLET in 1 BOTTLE, PLASTIC (75907-005-30)Marketed from Mar 15, 2024

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 — 100 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Dr. Reddy's Labratories Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 075389
Marketing start: Mar 15, 2024
Marketing end: Jun 30, 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 75907-005_e0bc8f4a-dc9b-7804-4479-ebe732449569SPL ID e0bc8f4a-dc9b-7804-4479-ebe732449569SPL set ID 95cef33b-c0e6-b17c-7cbb-f5c066872705RxCUI 833528, 834348, 835956UNII 976728SY6ZUPC 0375907005305
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

N475907000530 followed by a unit qualifier and the quantity

Package 75907-0005-30. 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 Apr 23, 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 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)

Other NDCs under ANDA 075389

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

FDA NDC Directory listings under ANDA 075389
Product	Strength	Form · route	Labeler	Product NDC
Amiodarone Hydrochloride	Amiodarone hydrochloride 200 mg/1	TabletOral	Dr. Reddy's Labratories Inc.	75907-006
Amiodarone Hydrochloride	Amiodarone hydrochloride 100 mg/1	TabletOral	AvPAK	50268-097