Prescription drug · ANDA
Betaxolol NDC 24658-700
Betaxolol hydrochloride 10 mg/1 · Tablet, Film coated · Oral · PuraCap Laboratories LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 24658-700-01 | 24658070001 | 100 TABLET, FILM COATED in 1 BOTTLE (24658-700-01)Marketed from Dec 15, 2016 |
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)
- Betaxolol
- Generic name (nonproprietary)
- betaxolol
- Active ingredients
- Betaxolol hydrochloride — 10 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- PuraCap Laboratories LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 075541
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic beta-Antagonists (Mechanism)
- Identifiers
- Product ID 24658-700_7ee988e7-153d-4d55-b4ec-1a8da8f78f1dSPL ID 7ee988e7-153d-4d55-b4ec-1a8da8f78f1dSPL set ID e198244d-fda3-4015-8c01-390f3f88e238RxCUI 1297753, 1297757UNII 6X97D2XT0OUPC 0324658701011
- 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
N424658070001followed by a unit qualifier and the quantityPackage 24658-0700-01. 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 Betaxolol is indicated in the management of hypertension. It may be used alone or concomitantly with other antihypertensive agents, particularly thiazide-type diuretics.
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 075541
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 |
|---|---|---|---|---|
| Betaxolol | Betaxolol hydrochloride 20 mg/1 | Tablet, Film coatedOral | PuraCap Laboratories LLC | 24658-701 |
| Betaxolol | Betaxolol hydrochloride 20 mg/1 | Tablet, Film coatedOral | Epic Pharma LLC | 42806-039 |
| Betaxolol | Betaxolol hydrochloride 10 mg/1 | Tablet, Film coatedOral | Epic Pharma LLC | 42806-038 |