Prescription drug · ANDA
Bepotastine Besilate NDC 70069-711
Bepotastine besilate 15 mg/mL · Solution · Ophthalmic · Somerset Therapeutics, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70069-711-01 | 70069071101 | 1 BOTTLE in 1 CARTON (70069-711-01) / 5 mL in 1 BOTTLEMarketed from Oct 10, 2024 |
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)
- Bepotastine Besilate
- Generic name (nonproprietary)
- bepotastine besilate
- Active ingredients
- Bepotastine besilate — 15 mg/mL
- Dosage form
- Solution
- Route
- Ophthalmic
- Labeler
- Somerset Therapeutics, LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 217770
- Marketing start
- Listing expires
- Identifiers
- Product ID 70069-711_32be8aa1-ad8e-4840-8d22-49316257cda4SPL ID 32be8aa1-ad8e-4840-8d22-49316257cda4SPL set ID cd6a061d-8ad7-4ad1-b039-1e3aa3435d32RxCUI 863038UNII 6W18MO1QR3UPC 0370069712016, 0370069711019
- Pharmacologic class
- Histamine-1 Receptor Antagonist
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. Ophthalmic products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N470069071101followed by a unit qualifier and the quantityPackage 70069-0711-01. 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)
Bepotastine besilate ophthalmic solution 1.5% is a histamine H 1 receptor antagonist indicated for the treatment of itching associated with signs and symptoms of allergic conjunctivitis. Bepotastine besilate ophthalmic solution is a histamine H 1 receptor antagonist indicated for the treatment of itching associated with allergic conjunctivitis.
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 217770
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 |
|---|---|---|---|---|
| Bepotastine Besilate | Bepotastine besilate 15 mg/mL | SolutionOphthalmic | Somerset Therapeutics, LLC | 70069-712 |