NDC codes

FDA NDC Directory
Product NDC (as listed)51662-1358Labeler and product segments. Claims need a package NDC.
Product NDC at billing width51662-1358Add 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
51662-1358-151662135801516621358011 VIAL, GLASS in 1 CARTON (51662-1358-1) / 18 mL in 1 VIAL, GLASSMarketed from Jul 6, 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 — 50 mg/mL
Dosage form
Injection, Solution
Route
Intravenous
Labeler
HF Acquisition Co LLC, DBA HealthFirstNDC labeler code 51662
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 076217
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 51662-1358_100d6df7-3400-6068-e063-6294a90a74f3SPL ID 100d6df7-3400-6068-e063-6294a90a74f3SPL set ID 8d088060-70b5-e796-e053-2995a90a0969UNII 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 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

N451662135801 followed by a unit qualifier and the quantity

Package 51662-1358-01. 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 .

Indications (excerpt from the label)

Amiodarone hydrochloride 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 s…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 51662-1358

What is NDC 51662-1358?
51662-1358 is the product NDC for Amiodarone Hydrochloride, Amiodarone hydrochloride 50 mg/mL injection, solution, listed with the FDA by HF Acquisition Co LLC, DBA HealthFirst. 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?
HF Acquisition Co LLC, DBA HealthFirst, NDC labeler code 51662. 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
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
amiodarone hydrochlorideAmiodarone hydrochloride 200 mg/1TabletOralSafecor Health LLC48433-15448433-0154-20
Amiodarone HydrochlorideAmiodarone hydrochloride 200 mg/1TabletOralMajor Pharmaceuticals0904-757600904-7576-61
Amiodarone HydrochlorideAmiodarone hydrochloride 50 mg/mLInjection, SolutionIntravenousHenry Schein, Inc.0404-977200404-9772-03
Amiodarone HydrochlorideAmiodarone hydrochloride 50 mg/mLInjection, SolutionIntravenousFresenius Kabi USA, LLC65219-64365219-0643-03
Amiodarone HydrochlorideAmiodarone hydrochloride 50 mg/mLInjection, SolutionIntravenousFresenius Kabi USA, LLC65219-64565219-0645-09
Amiodarone HydrochlorideAmiodarone hydrochloride 50 mg/mLInjection, SolutionIntravenousMedical Purchasing Solutions, LLC.71872-735471872-7354-01
Amiodarone HydrochlorideAmiodarone hydrochloride 50 mg/mLInjection, SolutionIntravenousSlate Run Pharmaceuticals70436-23270436-0232-5070436-0232-5270436-0232-62
Amiodarone HydrochlorideAmiodarone hydrochloride 100 mg/1TabletOralDr. Reddy's Labratories Inc.75907-00575907-0005-30
Amiodarone HydrochlorideAmiodarone hydrochloride 200 mg/1TabletOralDr. Reddy's Labratories Inc.75907-00675907-0006-60
Amiodarone HydrochlorideAmiodarone hydrochloride 50 mg/mLInjection, SolutionIntravenousMylan Institutional LLC72078-04672078-0046-0972078-0046-18

All 62 Amiodarone Hydrochloride NDCs

Other NDCs under ANDA 076217

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

FDA NDC Directory listings under ANDA 076217
ProductStrengthForm · routeLabelerProduct NDC
Amiodarone HydrochlorideAmiodarone hydrochloride 50 mg/mLInjection, SolutionIntravenousMylan Institutional LLC67457-153
Amiodarone HydrochlorideAmiodarone hydrochloride 50 mg/mLInjection, SolutionIntravenousMedical Purchasing Solutions, LLC71872-7163
Amiodarone HydrochlorideAmiodarone hydrochloride 50 mg/mLInjection, SolutionIntravenousMylan Institutional LLC72078-046
Amiodarone HydrochlorideAmiodarone hydrochloride 50 mg/mLInjection, SolutionIntravenousProPharma Distribution84549-153

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