Prescription drug · ANDA
Acebutolol Hydrochloride NDC 65162-670
Acebutolol hydrochloride 400 mg/1 · Capsule · Oral · Amneal Pharmaceuticals LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 65162-670-03 | 65162067003 | 30 CAPSULE in 1 BOTTLE (65162-670-03)Marketed from Dec 1, 2009 | |
| 65162-670-10 | 65162067010 | 100 CAPSULE in 1 BOTTLE (65162-670-10)Marketed from Dec 1, 2009 | |
| 65162-670-50 | 65162067050 | 500 CAPSULE in 1 BOTTLE (65162-670-50)Marketed from Dec 1, 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)
- Acebutolol Hydrochloride
- Generic name (nonproprietary)
- acebutolol hydrochloride
- Active ingredients
- Acebutolol hydrochloride — 400 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Amneal Pharmaceuticals LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 075047
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic beta-Antagonists (Mechanism)
- Identifiers
- Product ID 65162-670_6e350ff3-ef29-4f7b-acc2-5f4bfe188233SPL ID 6e350ff3-ef29-4f7b-acc2-5f4bfe188233SPL set ID 28f8c26c-a1e1-4485-a45f-05c82f7a34b5RxCUI 998685, 998689UNII B025Y34C54UPC 0365162670103, 0365162669107
- Pharmacologic class
- beta-Adrenergic Blocker
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
N465162067003followed by a unit qualifier and the quantityPackage 65162-0670-03. 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)
INDICATIONS AND USAGE Hypertension Acebutolol hydrochloride capsules, USP are indicated for the management of hypertension in adults. It may be used alone or in combination with other antihypertensive agents, especially thiazide-type diuretics. Ventricular Arrhythmias Acebutolol hydrochloride capsules, USP are indicated in the management of ventricular premature beats; it reduces the total number of premature beats, as well as the number of paired and multiform ventricular ectopic beats, and R-on-T beats.
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 075047
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 |
|---|---|---|---|---|
| Acebutolol Hydrochloride | Acebutolol hydrochloride 200 mg/1 | CapsuleOral | AvKARE | 42291-010 |
| Acebutolol Hydrochloride | Acebutolol hydrochloride 200 mg/1 | CapsuleOral | Amneal Pharmaceuticals LLC | 65162-669 |
| Acebutolol Hydrochloride | Acebutolol hydrochloride 200 mg/1 | CapsuleOral | AvPAK | 50268-050 |
| Acebutolol Hydrochloride | Acebutolol hydrochloride 200 mg/1 | CapsuleOral | Amneal Pharmaceuticals of New York LLC | 53746-669 |
| Acebutolol Hydrochloride | Acebutolol hydrochloride 400 mg/1 | CapsuleOral | Amneal Pharmaceuticals of New York LLC | 53746-670 |