Prescription drug · ANDA
Amiodarone Hydrochloride NDC 0143-9875
Amiodarone hydrochloride 50 mg/mL · Injection, Solution · Intravenous · Hikma Pharmaceuticals USA Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0143-9875-10 | 0014398751000143987510 | 10 VIAL in 1 BOX (0143-9875-10) / 3 mL in 1 VIAL (0143-9875-01)Marketed from Feb 25, 2008 | |
| 0143-9875-25 | 0014398752500143987525 | 25 VIAL in 1 BOX (0143-9875-25) / 3 mL in 1 VIAL (0143-9875-01)Marketed from Feb 25, 2008 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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
- Hikma Pharmaceuticals USA Inc.NDC labeler code 0143
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 077234
- 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 0143-9875_624376cc-5fa3-410a-95de-ef975e2ea501SPL ID 624376cc-5fa3-410a-95de-ef975e2ea501SPL set ID 51772745-9ea9-42cd-97e6-7266f41ae3caRxCUI 1663224UNII 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.
- NDC on a medical claim
N400143987510followed by a unit qualifier and the quantityPackage 00143-9875-10. 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, USP 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 Hydrochloride Injection, USP 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 Hydrochloride Injection, USP patients may be transferred to oral amiodarone therapy [see Dosage and Administration ( 2 )] . Use Amiodarone Hydrochloride Injection, USP for acute treatment until the patient's ventricular arrhythmias are sta…
Excerpt only. Read the full label for complete information.
About NDC 0143-9875
- What is NDC 0143-9875?
- 0143-9875 is the product NDC for Amiodarone Hydrochloride, Amiodarone hydrochloride 50 mg/mL injection, solution, listed with the FDA by Hikma Pharmaceuticals USA Inc.. It has 2 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?
- Hikma Pharmaceuticals USA Inc., NDC labeler code 0143. 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.
Related NDCs: other Amiodarone Hydrochloride products
Other finished products listed under the same name: strengths, forms and labelers.
| 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 |
Other NDCs under ANDA 077234
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Amiodarone Hydrochloride | Amiodarone hydrochloride 50 mg/mL | Injection, SolutionIntravenous | Henry Schein, Inc. | 0404-9772 |
| Amiodarone Hydrochloride | Amiodarone hydrochloride 50 mg/mL | Injection, SolutionIntravenous | HF Acquisition Co LLC, DBA HealthFirst | 51662-1205 |
| Amiodarone Hydrochloride | Amiodarone hydrochloride 50 mg/mL | Injection, SolutionIntravenous | REMEDYREPACK INC. | 70518-1231 |
| Amiodarone Hydrochloride | Amiodarone hydrochloride 50 mg/mL | Injection, SolutionIntravenous | Medical Purchasing Solutions, LLC | 71872-7000 |