Prescription drug · NDA
Bepreve (Bepotastine besilate) NDC 24208-629
Bepotastine besylate 15 mg/mL · Solution/ drops · Ophthalmic · Bausch & Lomb Incorporated
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 24208-629-01 | 24208062901 | 1 BOTTLE, DROPPER in 1 CARTON (24208-629-01) / 10 mL in 1 BOTTLE, DROPPERMarketed from Sep 8, 2009 | |
| 24208-629-02 | 24208062902 | 1 BOTTLE, DROPPER in 1 CARTON (24208-629-02) / 5 mL in 1 BOTTLE, DROPPERMarketed from Sep 8, 2009 | |
| 24208-629-03 | 24208062903 | 1 BOTTLE, DROPPER in 1 CARTON (24208-629-03) / 1 mL in 1 BOTTLE, DROPPERMarketed from Sep 8, 2009 |
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)
- Bepreve
- Generic name (nonproprietary)
- bepotastine besilate
- Active ingredients
- Bepotastine besylate — 15 mg/mL
- Dosage form
- Solution/ drops
- Route
- Ophthalmic
- Labeler
- Bausch & Lomb IncorporatedNDC labeler code 24208
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 022288
- Marketing start
- Listing expires
- Identifiers
- Product ID 24208-629_a4c88d72-eb17-446a-9da5-6bcf1263377fSPL ID a4c88d72-eb17-446a-9da5-6bcf1263377fSPL set ID 68bbf6a0-c4b5-47c1-8a1c-08220fbdbce6RxCUI 863038, 863042UNII 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
N424208062901followed by a unit qualifier and the quantityPackage 24208-0629-01. 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)
BEPREVE ® (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. BEPREVE is a histamine H1 receptor antagonist indicated for the treatment of itching associated with allergic conjunctivitis. ( 1 )
Excerpt only. Read the full label for complete information.
About NDC 24208-629
- What is NDC 24208-629?
- 24208-629 is the product NDC for Bepreve (bepotastine besilate), Bepotastine besylate 15 mg/mL solution/ drops, listed with the FDA by Bausch & Lomb Incorporated. It has 3 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Bepreve (Bepotastine besilate).
- What is the active ingredient?
- Bepotastine besylate.
- Who is the labeler?
- Bausch & Lomb Incorporated, NDC labeler code 24208. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Bepreve?
- None: this is the only finished product listed under this name.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Other NDCs under NDA 022288
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 | Solution/ dropsOphthalmic | Bausch & Lomb Incorporated | 24208-630 |
| Bepotastine Besilate | Bepotastine besylate 15 mg/mL | Solution/ dropsOphthalmic | Bausch & Lomb Americas Inc. | 82260-630 |