What is NDC 0378-7055?

0378-7055 is the product NDC for Bepotastine Besilate, Bepotastine besilate 15 mg/mL solution/ drops, listed with the FDA by Mylan Pharmaceuticals Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.

Mylan Pharmaceuticals Inc., NDC labeler code 0378. 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 0378-7055

NDC codes

FDA NDC Directory

Product NDC (as listed)0378-7055Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00378-7055Add 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
0378-7055-35	0037870553500378705535	1 BOTTLE, DROPPER in 1 CARTON (0378-7055-35) / 5 mL in 1 BOTTLE, DROPPERMarketed from May 28, 2021
0378-7055-67	0037870556700378705567	1 BOTTLE, DROPPER in 1 CARTON (0378-7055-67) / 10 mL in 1 BOTTLE, DROPPERMarketed from May 28, 2021

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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/ drops
Route: Ophthalmic
Labeler: Mylan Pharmaceuticals Inc.NDC labeler code 0378
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 206220
Marketing start: May 28, 2021
Listing expires: Dec 31, 2027
Identifiers: Product ID 0378-7055_c8ce95fa-e800-433e-8d40-70a6b1e06140SPL ID c8ce95fa-e800-433e-8d40-70a6b1e06140SPL set ID 75178670-aa57-45f9-94d5-efcf8305e683RxCUI 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

N400378705535 followed by a unit qualifier and the quantity

Package 00378-7055-35. 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 Mar 20, 2018.

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. ( 1 )

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0378-7055

What is NDC 0378-7055?: 0378-7055 is the product NDC for Bepotastine Besilate, Bepotastine besilate 15 mg/mL solution/ drops, listed with the FDA by Mylan Pharmaceuticals 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 besilate.
Who is the labeler?: Mylan Pharmaceuticals Inc., NDC labeler code 0378. 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	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