Amiodarone Hydrochloride NDC 29300-359

NDC codes

FDA NDC Directory

Product NDC (as listed)29300-359Labeler and product segments. Claims need a package NDC.

Product NDC at billing width29300-0359Add 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
29300-359-05	29300035905	500 TABLET in 1 BOTTLE (29300-359-05)Marketed from Sep 1, 2020
29300-359-16	29300035916	60 TABLET in 1 BOTTLE (29300-359-16)Marketed from Sep 1, 2020

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: Unichem Pharmaceuticals (USA), Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 213446
Marketing start: Sep 1, 2020
Listing expires: Dec 31, 2026
Other FDA classes: Cytochrome P450 1A2 Inhibitors (Mechanism)Cytochrome P450 2C9 Inhibitors (Mechanism)Cytochrome P450 2D6 Inhibitors (Mechanism)Cytochrome P450 3A4 Inhibitors (Mechanism)P-Glycoprotein Inhibitors (Mechanism)
Identifiers: Product ID 29300-359_ca43a6d6-5537-4881-bf75-b43ade430dd1SPL ID ca43a6d6-5537-4881-bf75-b43ade430dd1SPL set ID a20d0c03-cfda-49d1-88c9-be1bf295bc6cRxCUI 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

N429300035905 followed by a unit qualifier and the quantity

Package 29300-0359-05. 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 213446

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

FDA NDC Directory listings under ANDA 213446
Product	Strength	Form · route	Labeler	Product NDC
Amiodarone Hydrochloride	Amiodarone hydrochloride 200 mg/1	TabletOral	A-S Medication Solutions	50090-5766
Amiodarone Hydrochloride	Amiodarone hydrochloride 200 mg/1	TabletOral	REMEDYREPACK INC.	70518-3246
Amiodarone Hydrochloride	Amiodarone hydrochloride 200 mg/1	TabletOral	Bryant Ranch Prepack	71335-1942
Amiodarone Hydrochloride	Amiodarone hydrochloride 200 mg/1	TabletOral	Redpharm Drug	67296-2296