Prescription drug · ANDA
Amiodarone hydrochloride NDC 65841-631
Amiodarone hydrochloride 200 mg/1 · Tablet · Oral · Zydus Lifesciences Limited
NDC codes
FDA NDC DirectoryProduct NDC (as listed)65841-631Labeler and product segments. Claims need a package NDC.
Product NDC at billing width65841-0631Add the package segment from the table below.
| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 65841-631-05 | 6584106310565841063105 | 500 TABLET in 1 BOTTLE (65841-631-05)Marketed from Aug 10, 2009 | |
| 65841-631-06 | 6584106310665841063106 | 30 TABLET in 1 BOTTLE (65841-631-06)Marketed from Aug 10, 2009 | |
| 65841-631-10 | 6584106311065841063110 | 1000 TABLET in 1 BOTTLE (65841-631-10)Marketed from Aug 10, 2009 | |
| 65841-631-14 | 6584106311465841063114 | 60 TABLET in 1 BOTTLE (65841-631-14)Marketed from Aug 10, 2009 | |
| 65841-631-77 | 6584106317765841063177 | 10 BLISTER PACK in 1 CARTON (65841-631-77) / 10 TABLET in 1 BLISTER PACKMarketed 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 Lifesciences LimitedNDC labeler code 65841
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 079029
- 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 65841-631_aabb5533-5d41-49a3-b8b6-14627af57311SPL ID aabb5533-5d41-49a3-b8b6-14627af57311SPL set ID 3e8db251-e3c5-4fba-be9a-6044a92f0bebRxCUI 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
N465841063105followed by a unit qualifier and the quantityPackage 65841-0631-05. 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 .
About NDC 65841-631
- What is NDC 65841-631?
- 65841-631 is the product NDC for Amiodarone hydrochloride, Amiodarone hydrochloride 200 mg/1 tablet, listed with the FDA by Zydus Lifesciences Limited. 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 Lifesciences Limited, NDC labeler code 65841. 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 079029
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 | Safecor Health LLC | 48433-154 |
| 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 200 mg/1 | TabletOral | Zydus Pharmaceuticals USA Inc. | 68382-227 |
| 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 |