Prescription drug · ANDA
Betaxolol NDC 42806-038
Betaxolol hydrochloride 10 mg/1 · Tablet, Film coated · Oral · Epic Pharma LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 42806-038-01 | 4280600380142806003801 | 100 TABLET, FILM COATED in 1 BOTTLE (42806-038-01)Marketed from Jul 20, 2010 | |
| 42806-038-10 | 4280600381042806003810 | 1000 TABLET, FILM COATED in 1 BOTTLE (42806-038-10)Marketed from Jul 20, 2010 |
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
- Epic Pharma LLCNDC labeler code 42806
- 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 42806-038_666cb1d9-ec1f-453a-be4f-fafa2b67c1fdSPL ID 666cb1d9-ec1f-453a-be4f-fafa2b67c1fdSPL set ID bf716efe-0a9f-43b1-9d8a-c69330b82e18RxCUI 1297753, 1297757UNII 6X97D2XT0O
- 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
N442806003801followed by a unit qualifier and the quantityPackage 42806-0038-01. 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 42806-038
- What is NDC 42806-038?
- 42806-038 is the product NDC for Betaxolol, Betaxolol hydrochloride 10 mg/1 tablet, film coated, listed with the FDA by Epic Pharma LLC. It has 2 package NDCs, 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?
- Epic Pharma LLC, NDC labeler code 42806. 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 20 mg/1 | Tablet, Film coatedOral | PuraCap Laboratories LLC | 24658-701 | 24658-0701-01 |
| 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 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 |