Prescription drug · ANDA
Bepotastine Besilate Ophthalmic Solution 1.5% NDC 46708-598
Bepotastine besilate 15 mg/mL · Solution/ drops · Ophthalmic · Alembic Pharmaceuticals Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 46708-598-05 | 4670805980546708059805 | 1 BOTTLE in 1 CARTON (46708-598-05) / 5 mL in 1 BOTTLEMarketed from Jul 18, 2023 | |
| 46708-598-10 | 4670805981046708059810 | 1 BOTTLE in 1 CARTON (46708-598-10) / 10 mL in 1 BOTTLEMarketed from Apr 5, 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)
- Bepotastine Besilate Ophthalmic Solution 1.5%
- Generic name (nonproprietary)
- bepotastine besilate ophthalmic solution 1.5%
- Active ingredients
- Bepotastine besilate — 15 mg/mL
- Dosage form
- Solution/ drops
- Route
- Ophthalmic
- Labeler
- Alembic Pharmaceuticals LimitedNDC labeler code 46708
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 214588
- Marketing start
- Listing expires
- Identifiers
- Product ID 46708-598_de111d74-c740-47b3-adc7-4b855df2c561SPL ID de111d74-c740-47b3-adc7-4b855df2c561SPL set ID de111d74-c740-47b3-adc7-4b855df2c561RxCUI 863038UNII 6W18MO1QR3
- 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
N446708059805followed by a unit qualifier and the quantityPackage 46708-0598-05. 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 H1 receptor antagonist indicated for the treatment of itching associated with signs and symptoms of allergic conjunctivitis. Bepotastine besilate ophthalmic solution is a histamine H1 receptor antagonist indicated for the treatment of itching associated with allergic conjunctivitis.
Excerpt only. Read the full label for complete information.
About NDC 46708-598
- What is NDC 46708-598?
- 46708-598 is the product NDC for Bepotastine Besilate Ophthalmic Solution 1.5%, Bepotastine besilate 15 mg/mL solution/ drops, listed with the FDA by Alembic Pharmaceuticals Limited. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Bepotastine Besilate Ophthalmic Solution 1.5%.
- What is the active ingredient?
- Bepotastine besilate.
- Who is the labeler?
- Alembic Pharmaceuticals Limited, NDC labeler code 46708. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Bepotastine Besilate Ophthalmic Solution 1.5%?
- 1 other product NDC are listed under this name. See all Bepotastine Besilate Ophthalmic Solution 1.5% NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Bepotastine Besilate Ophthalmic Solution 1.5% products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Bepotastine Besilate Ophthalmic Solution 1.5% | Bepotastine besilate 15 mg/mL | Solution/ dropsOphthalmic | Alembic Pharmaceuticals Inc. | 62332-598 | 62332-0598-0562332-0598-10 |
Other NDCs under ANDA 214588
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 Ophthalmic Solution 1.5% | Bepotastine besilate 15 mg/mL | Solution/ dropsOphthalmic | Alembic Pharmaceuticals Inc. | 62332-598 |