Prescription drug · ANDA
Amiodarone Hydrochloride NDC 0904-6993
Amiodarone hydrochloride 200 mg/1 · Tablet · Oral · Major Pharmaceuticals
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0904-6993-61 | 0090469936100904699361 | 100 BLISTER PACK in 1 CARTON (0904-6993-61) / 1 TABLET in 1 BLISTER PACKMarketed from Apr 20, 2020 |
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 — 200 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Major PharmaceuticalsNDC labeler code 0904
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 075424
- Marketing start
- Marketing end
- 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 0904-6993_64f4746d-7518-4865-a7e4-8c3f17ace734SPL ID 64f4746d-7518-4865-a7e4-8c3f17ace734SPL set ID 352ed423-fc16-47bb-8e25-98e1c20f9991RxCUI 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
N400904699361followed by a unit qualifier and the quantityPackage 00904-6993-61. 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 . 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 tablets are an antiarrhythmic indicated for: • Recurrent ventricular fibrillation. ( 1 ) • Recurrent hemodynamically unstable ventricular tachycardia. ( 1 )
Excerpt only. Read the full label for complete information.
About NDC 0904-6993
- What is NDC 0904-6993?
- 0904-6993 is the product NDC for Amiodarone Hydrochloride, Amiodarone hydrochloride 200 mg/1 tablet, listed with the FDA by Major Pharmaceuticals. 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?
- Major Pharmaceuticals, NDC labeler code 0904. 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 075424
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 200 mg/1 | TabletOral | Sun Pharmaceutical Industries, Inc. | 51672-4025 |
| Amiodarone Hydrochloride | Amiodarone hydrochloride 100 mg/1 | TabletOral | Sun Pharmaceutical Industries, Inc. | 51672-4055 |
| Amiodarone Hydrochloride | Amiodarone hydrochloride 200 mg/1 | TabletOral | Cardinal Health 107, LLC | 55154-3365 |
| Amiodarone Hydrochloride | Amiodarone hydrochloride 200 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-0881 |