Prescription drug · ANDA
Acebutolol Hydrochloride NDC 42291-010
Acebutolol hydrochloride 200 mg/1 · Capsule · Oral · AvKARE
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 42291-010-01 | 42291001001 | 100 CAPSULE in 1 BOTTLE (42291-010-01)Marketed from Apr 26, 2023 |
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 — 200 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- AvKARENDC labeler code 42291
- 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 42291-010_48481cfc-a410-bc0a-e063-6294a90a7bafSPL ID 48481cfc-a410-bc0a-e063-6294a90a7bafSPL set ID fa40a564-a579-15c1-e053-6294a90ad8e9RxCUI 998689UNII B025Y34C54
- 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
N442291001001followed by a unit qualifier and the quantityPackage 42291-0010-01. 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)
INDICATIONS AND USAGE Hypertension Acebutolol HCl capsules 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 HCl capsules 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.
About NDC 42291-010
- What is NDC 42291-010?
- 42291-010 is the product NDC for Acebutolol Hydrochloride, Acebutolol hydrochloride 200 mg/1 capsule, listed with the FDA by AvKARE. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Acebutolol Hydrochloride.
- What is the active ingredient?
- Acebutolol hydrochloride.
- Who is the labeler?
- AvKARE, NDC labeler code 42291. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Acebutolol Hydrochloride?
- 9 other product NDCs are listed under this name. See all Acebutolol Hydrochloride NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Acebutolol 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) |
|---|---|---|---|---|---|
| Acebutolol Hydrochloride | Acebutolol hydrochloride 200 mg/1 | CapsuleOral | ANI Pharmaceuticals, Inc. | 62559-255 | 62559-0255-01 |
| Acebutolol Hydrochloride | Acebutolol hydrochloride 400 mg/1 | CapsuleOral | ANI Pharmaceuticals, Inc. | 62559-256 | 62559-0256-01 |
| Acebutolol Hydrochloride | Acebutolol hydrochloride 200 mg/1 | CapsuleOral | AvPAK | 50268-050 | 50268-0050-15 |
| Acebutolol Hydrochloride | Acebutolol hydrochloride 200 mg/1 | CapsuleOral | Amneal Pharmaceuticals LLC | 65162-669 | 65162-0669-1065162-0669-50 |
| Acebutolol Hydrochloride | Acebutolol hydrochloride 400 mg/1 | CapsuleOral | Amneal Pharmaceuticals LLC | 65162-670 | 65162-0670-0365162-0670-1065162-0670-50 |
| Acebutolol Hydrochloride | Acebutolol hydrochloride 200 mg/1 | CapsuleOral | Amneal Pharmaceuticals of New York LLC | 53746-669 | 53746-0669-0153746-0669-05 |
| Acebutolol Hydrochloride | Acebutolol hydrochloride 400 mg/1 | CapsuleOral | Amneal Pharmaceuticals of New York LLC | 53746-670 | 53746-0670-0153746-0670-0553746-0670-30 |
| Acebutolol Hydrochloride | Acebutolol hydrochloride 200 mg/1 | CapsuleOral | Golden State Medical Supply, Inc. | 51407-666 | 51407-0666-01 |
| Acebutolol Hydrochloride | Acebutolol hydrochloride 400 mg/1 | CapsuleOral | Golden State Medical Supply, Inc. | 51407-667 | 51407-0667-01 |
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 | Amneal Pharmaceuticals of New York LLC | 53746-669 |
| Acebutolol Hydrochloride | Acebutolol hydrochloride 400 mg/1 | CapsuleOral | Amneal Pharmaceuticals of New York LLC | 53746-670 |
| Acebutolol Hydrochloride | Acebutolol hydrochloride 400 mg/1 | CapsuleOral | Amneal Pharmaceuticals LLC | 65162-670 |
| Acebutolol Hydrochloride | Acebutolol hydrochloride 200 mg/1 | CapsuleOral | Amneal Pharmaceuticals LLC | 65162-669 |
| Acebutolol Hydrochloride | Acebutolol hydrochloride 200 mg/1 | CapsuleOral | AvPAK | 50268-050 |