What is NDC 68083-112?

68083-112 is the product NDC for Amiodarone hydrochloride, Amiodarone hydrochloride 50 mg/mL injection, solution, listed with the FDA by Gland Pharma Limited. It has 1 package NDC, shown above in 10- and 11-digit form.

Gland Pharma Limited, NDC labeler code 68083. 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 68083-112

NDC codes

FDA NDC Directory

Product NDC (as listed)68083-112Labeler and product segments. Claims need a package NDC.

Product NDC at billing width68083-0112Add 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
68083-112-01	6808301120168083011201	10 SYRINGE in 1 CARTON (68083-112-01) / 3 mL in 1 SYRINGEMarketed from Jul 15, 2013

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 — 50 mg/mL
Dosage form: Injection, Solution
Route: Intravenous
Labeler: Gland Pharma LimitedNDC labeler code 68083
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 077161
Marketing start: Jul 15, 2013
Listing expires: Dec 31, 2027
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 68083-112_2c1bc6a8-20ff-483a-ae28-fb31fa5f684aSPL ID 2c1bc6a8-20ff-483a-ae28-fb31fa5f684aSPL set ID 1f00c333-9667-4ebc-8849-009a3779c0c9RxCUI 834357UNII 976728SY6ZUPC 0368083112011
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 drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.

Administration

Drug administration (CPT 96360–96549)

When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.

How CPT relates to drug billing

NDC on a medical claim

N468083011201 followed by a unit qualifier and the quantity

Package 68083-0112-01. 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 Aug 26, 2021.

Indications (excerpt from the label)

Amiodarone injection is indicated for initiation of treatment and prophylaxis of frequently recurring ventricular fibrillation (VF) and hemodynamically unstable ventricular tachycardia (VT) in patients refractory to other therapy. Amiodarone also can be used to treat patients with VT/VF for whom oral amiodarone is indicated, but who are unable to take oral medication. During or after treatment with amiodarone, patients may be transferred to oral amiodarone therapy [see Dosage and Administration (2)] . Use amiodarone for acute treatment until the patient's ventricular arrhythmias are stabilized. Most patients will require this therapy for 48 to 96 hours, but amiodarone may be safely administe…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 68083-112

What is NDC 68083-112?: 68083-112 is the product NDC for Amiodarone hydrochloride, Amiodarone hydrochloride 50 mg/mL injection, solution, listed with the FDA by Gland Pharma Limited. 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?: Gland Pharma Limited, NDC labeler code 68083. 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	Medical Purchasing Solutions, LLC.	71872-7354	71872-7354-01
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 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