Prescription drug · ANDA
Betaxolol NDC 24658-701
Betaxolol hydrochloride 20 mg/1 · Tablet, Film coated · Oral · PuraCap Laboratories LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 24658-701-01 | 2465807010124658070101 | 100 TABLET, FILM COATED in 1 BOTTLE (24658-701-01)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 — 20 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- PuraCap Laboratories LLCNDC labeler code 24658
- 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 24658-701_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
N424658070101followed by a unit qualifier and the quantityPackage 24658-0701-01. 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.
About NDC 24658-701
- What is NDC 24658-701?
- 24658-701 is the product NDC for Betaxolol, Betaxolol hydrochloride 20 mg/1 tablet, film coated, listed with the FDA by PuraCap Laboratories LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Betaxolol.
- What is the active ingredient?
- Betaxolol hydrochloride.
- Who is the labeler?
- PuraCap Laboratories LLC, NDC labeler code 24658. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Betaxolol?
- 3 other product NDCs are listed under this name. See all Betaxolol NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Betaxolol products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Betaxolol | Betaxolol hydrochloride 10 mg/1 | Tablet, Film coatedOral | PuraCap Laboratories LLC | 24658-700 | 24658-0700-01 |
| Betaxolol | Betaxolol hydrochloride 10 mg/1 | Tablet, Film coatedOral | Epic Pharma LLC | 42806-038 | 42806-0038-0142806-0038-10 |
| Betaxolol | Betaxolol hydrochloride 20 mg/1 | Tablet, Film coatedOral | Epic Pharma LLC | 42806-039 | 42806-0039-0142806-0039-10 |
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 10 mg/1 | Tablet, Film coatedOral | PuraCap Laboratories LLC | 24658-700 |
| Betaxolol | Betaxolol hydrochloride 10 mg/1 | Tablet, Film coatedOral | Epic Pharma LLC | 42806-038 |
| Betaxolol | Betaxolol hydrochloride 20 mg/1 | Tablet, Film coatedOral | Epic Pharma LLC | 42806-039 |