What is NDC 68382-227?

68382-227 is the product NDC for amiodarone hydrochloride, Amiodarone hydrochloride 200 mg/1 tablet, listed with the FDA by Zydus Pharmaceuticals USA Inc.. It has 5 package NDCs, shown above in 10- and 11-digit form.

Zydus Pharmaceuticals USA Inc., NDC labeler code 68382. 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.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

amiodarone hydrochloride NDC 68382-227

NDC codes

FDA NDC Directory

Product NDC (as listed)68382-227Labeler and product segments. Claims need a package NDC.

Product NDC at billing width68382-0227Add 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
68382-227-05	68382022705	500 TABLET in 1 BOTTLE (68382-227-05)Marketed from Aug 10, 2009
68382-227-06	68382022706	30 TABLET in 1 BOTTLE (68382-227-06)Marketed from Aug 10, 2009
68382-227-10	68382022710	1000 TABLET in 1 BOTTLE (68382-227-10)Marketed from Aug 10, 2009
68382-227-14	68382022714	60 TABLET in 1 BOTTLE (68382-227-14)Marketed from Aug 10, 2009
68382-227-77	68382022777	100 BLISTER PACK in 1 CARTON (68382-227-77) / 1 TABLET in 1 BLISTER PACK (68382-227-30)Marketed from Aug 10, 2009

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: Zydus Pharmaceuticals USA Inc.NDC labeler code 68382
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 079029
Marketing start: Aug 10, 2009
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 68382-227_b3f11ad6-9f3b-4054-9c51-3d2614c1002eSPL ID b3f11ad6-9f3b-4054-9c51-3d2614c1002eSPL set ID b41cbcb5-9c5d-4e45-a4f2-952df5f22c00RxCUI 833528, 834348, 835956UNII 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

N468382022705 followed by a unit qualifier and the quantity

Package 68382-0227-05. 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

Current FDA label (SPL), effective Mar 16, 2023. 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 68382-227

What is NDC 68382-227?: 68382-227 is the product NDC for amiodarone hydrochloride, Amiodarone hydrochloride 200 mg/1 tablet, listed with the FDA by Zydus Pharmaceuticals USA Inc.. It has 5 package NDCs, 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?: Zydus Pharmaceuticals USA Inc., NDC labeler code 68382. 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
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
amiodarone hydrochloride	Amiodarone hydrochloride 200 mg/1	TabletOral	Safecor Health LLC	48433-154	48433-0154-20
Amiodarone Hydrochloride	Amiodarone hydrochloride 200 mg/1	TabletOral	Major Pharmaceuticals	0904-7576	00904-7576-61
Amiodarone Hydrochloride	Amiodarone hydrochloride 50 mg/mL	Injection, SolutionIntravenous	Henry Schein, Inc.	0404-9772	00404-9772-03
Amiodarone Hydrochloride	Amiodarone hydrochloride 50 mg/mL	Injection, SolutionIntravenous	Fresenius Kabi USA, LLC	65219-643	65219-0643-03
Amiodarone Hydrochloride	Amiodarone hydrochloride 50 mg/mL	Injection, SolutionIntravenous	Fresenius Kabi USA, LLC	65219-645	65219-0645-09
Amiodarone Hydrochloride	Amiodarone hydrochloride 50 mg/mL	Injection, SolutionIntravenous	Slate Run Pharmaceuticals	70436-232	70436-0232-5070436-0232-5270436-0232-62
Amiodarone Hydrochloride	Amiodarone hydrochloride 50 mg/mL	Injection, SolutionIntravenous	Medical Purchasing Solutions, LLC.	71872-7354	71872-7354-01
Amiodarone Hydrochloride	Amiodarone hydrochloride 100 mg/1	TabletOral	Dr. Reddy's Labratories Inc.	75907-005	75907-0005-30
Amiodarone Hydrochloride	Amiodarone hydrochloride 200 mg/1	TabletOral	Dr. Reddy's Labratories Inc.	75907-006	75907-0006-60
Amiodarone Hydrochloride	Amiodarone hydrochloride 50 mg/mL	Injection, SolutionIntravenous	Mylan Institutional LLC	72078-046	72078-0046-0972078-0046-18

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
Product	Strength	Form · route	Labeler	Product NDC
amiodarone hydrochloride	Amiodarone hydrochloride 200 mg/1	TabletOral	Safecor Health LLC	48433-154
Amiodarone hydrochloride	Amiodarone hydrochloride 200 mg/1	TabletOral	Zydus Lifesciences Limited	65841-631
Amiodarone hydrochloride	Amiodarone hydrochloride 100 mg/1	TabletOral	Zydus Lifesciences Limited	65841-840
Amiodarone hydrochloride	Amiodarone hydrochloride 400 mg/1	TabletOral	Zydus Lifesciences Limited	65841-841
amiodarone hydrochloride	Amiodarone hydrochloride 100 mg/1	TabletOral	Zydus Pharmaceuticals USA Inc.	68382-297
amiodarone hydrochloride	Amiodarone hydrochloride 400 mg/1	TabletOral	Zydus Pharmaceuticals USA Inc.	68382-298