Olopatadine Hydrochloride NDC 0536-1445

NDC codes

FDA NDC Directory

Product NDC (as listed)0536-1445Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00536-1445Add 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
0536-1445-40	00536144540	1 BOTTLE in 1 CARTON (0536-1445-40) / 5 mL in 1 BOTTLEMarketed from Apr 15, 2025

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): Olopatadine Hydrochloride
Generic name (nonproprietary): olopatadine hydrochloride ophthalmic solution
Active ingredients: Olopatadine hydrochloride — 1 mg/mL
Dosage form: Solution/ drops
Route: Ophthalmic
Labeler: RUGBY LABORATORIES
Product type: Over-the-counter drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 206046
Marketing start: Apr 15, 2025
Listing expires: Dec 31, 2027
Other FDA classes: Decreased Histamine Release (Physiologic effect)Histamine H1 Receptor Antagonists (Mechanism)
Identifiers: Product ID 0536-1445_5b8db4fc-fc76-431b-e063-6294a90a51f8SPL ID 5b8db4fc-fc76-431b-e063-6294a90a51f8
Pharmacologic class: Histamine-1 Receptor Antagonist; Histamine-1 Receptor Inhibitor; Mast Cell Stabilizer

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

N400536144540 followed by a unit qualifier and the quantity

Package 00536-1445-40. 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

The FDA listing for this product does not reference a label (SPL) set.

Other NDCs under ANDA 206046

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

FDA NDC Directory listings under ANDA 206046
Product	Strength	Form · route	Labeler	Product NDC
Olopatadine Hydrochloride	Olopatadine hydrochloride 1 mg/mL	SolutionOphthalmic	TARGET CORPORATION	82442-966
Equate Olopatadine Hydrochloride Ophthalmic Solutionolopatadine hydrochloride ophthalmic solution	Olopatadine hydrochloride 1 mg/mL	SolutionOphthalmic	WAL-MART STORES, INC.,	79903-319
Olopatadine Hydrochloride Ophthalmic Solution	Olopatadine hydrochloride 1 mg/mL	SolutionOphthalmic	Bausch & Lomb Incorporated	24208-966
Leader Olopatadine Hydrochloride Ophthalmic Solutionolopatadine hydrochloride ophthalmic solution	Olopatadine hydrochloride 1 mg/mL	SolutionOphthalmic	CARDINAL HEALTH	70000-0717
Olopatadine Hydrochloride Ophthalmic Solution	Olopatadine hydrochloride 1 mg/mL	SolutionOphthalmic	WALGREEN COMPANY	0363-0867