What is NDC 82260-630?

82260-630 is the product NDC for Bepotastine Besilate, Bepotastine besylate 15 mg/mL solution/ drops, listed with the FDA by Bausch & Lomb Americas Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.

Bausch & Lomb Americas Inc., NDC labeler code 82260. 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?

4 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Bepotastine Besilate NDC 82260-630

NDC codes

FDA NDC Directory

Product NDC (as listed)82260-630Labeler and product segments. Claims need a package NDC.

Product NDC at billing width82260-0630Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
82260-630-05	8226006300582260063005	1 BOTTLE, DROPPER in 1 CARTON (82260-630-05) / 5 mL in 1 BOTTLE, DROPPERMarketed from May 28, 2021
82260-630-10	8226006301082260063010	1 BOTTLE, DROPPER in 1 CARTON (82260-630-10) / 10 mL in 1 BOTTLE, DROPPERMarketed from May 28, 2021

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 besylate — 15 mg/mL
Dosage form: Solution/ drops
Route: Ophthalmic
Labeler: Bausch & Lomb Americas Inc.NDC labeler code 82260
Product type: Prescription drug
Marketing category: NDA authorized genericApplication NDA 022288
Marketing start: May 28, 2021
Listing expires: Dec 31, 2027
Identifiers: Product ID 82260-630_202287f2-01bc-1d43-e063-6294a90a8da1SPL ID 202287f2-01bc-1d43-e063-6294a90a8da1SPL set ID 70430ab5-cd0a-451e-acab-347a2f981898RxCUI 863038UNII 6W18MO1QR3UPC 0382260630051
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

N482260063005 followed by a unit qualifier and the quantity

Package 82260-0630-05. 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 Aug 20, 2024.

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 H1 receptor antagonist indicated for the treatment of itching associated with allergic conjunctivitis. ( 1 )

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 82260-630

What is NDC 82260-630?: 82260-630 is the product NDC for Bepotastine Besilate, Bepotastine besylate 15 mg/mL solution/ drops, listed with the FDA by Bausch & Lomb Americas Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Bepotastine Besilate.
What is the active ingredient?: Bepotastine besylate.
Who is the labeler?: Bausch & Lomb Americas Inc., NDC labeler code 82260. 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?: 4 other product NDCs are listed under this name. See all Bepotastine Besilate NDCs.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Bepotastine Besilate NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Bepotastine Besilate	Bepotastine besilate 15 mg/mL	SolutionOphthalmic	Somerset Therapeutics, LLC	70069-711	70069-0711-01
Bepotastine Besilate	Bepotastine besilate 15 mg/mL	SolutionOphthalmic	Somerset Therapeutics, LLC	70069-712	70069-0712-01
Bepotastine Besilate	Bepotastine besilate 15 mg/mL	Solution/ dropsOphthalmic	Mylan Pharmaceuticals Inc.	0378-7055	00378-7055-3500378-7055-67
Bepotastine Besilate	Bepotastine besilate 15 mg/mL	Solution/ dropsOphthalmic	Bausch & Lomb Incorporated	24208-630	24208-0630-0524208-0630-10

Other NDCs under NDA 022288

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under NDA 022288
Product	Strength	Form · route	Labeler	Product NDC
Bepotastine Besilate	Bepotastine besilate 15 mg/mL	Solution/ dropsOphthalmic	Bausch & Lomb Incorporated	24208-630
Beprevebepotastine besilate	Bepotastine besylate 15 mg/mL	Solution/ dropsOphthalmic	Bausch & Lomb Incorporated	24208-629