What is NDC 70069-712?

70069-712 is the product NDC for Bepotastine Besilate, Bepotastine besilate 15 mg/mL solution, listed with the FDA by Somerset Therapeutics, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.

Somerset Therapeutics, LLC, NDC labeler code 70069. 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 70069-712

NDC codes

FDA NDC Directory

Product NDC (as listed)70069-712Labeler and product segments. Claims need a package NDC.

Product NDC at billing width70069-0712Add 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
70069-712-01	7006907120170069071201	1 BOTTLE in 1 CARTON (70069-712-01) / 10 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, LLCNDC labeler code 70069
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 217770
Marketing start: Oct 10, 2024
Listing expires: Dec 31, 2026
Identifiers: Product ID 70069-712_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

N470069071201 followed by a unit qualifier and the quantity

Package 70069-0712-01. 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 Oct 10, 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 H 1 receptor antagonist indicated for the treatment of itching associated with allergic conjunctivitis.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 70069-712

What is NDC 70069-712?: 70069-712 is the product NDC for Bepotastine Besilate, Bepotastine besilate 15 mg/mL solution, listed with the FDA by Somerset Therapeutics, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Bepotastine Besilate.
What is the active ingredient?: Bepotastine besilate.
Who is the labeler?: Somerset Therapeutics, LLC, NDC labeler code 70069. 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	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
Bepotastine Besilate	Bepotastine besylate 15 mg/mL	Solution/ dropsOphthalmic	Bausch & Lomb Americas Inc.	82260-630	82260-0630-0582260-0630-10

Other NDCs under ANDA 217770

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

FDA NDC Directory listings under ANDA 217770
Product	Strength	Form · route	Labeler	Product NDC
Bepotastine Besilate	Bepotastine besilate 15 mg/mL	SolutionOphthalmic	Somerset Therapeutics, LLC	70069-711