olopatadine hydrochloride NDC 45802-104

NDC codes

FDA NDC Directory

Product NDC (as listed)45802-104Labeler and product segments. Claims need a package NDC.

Product NDC at billing width45802-0104Add 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
45802-104-01	45802010401	1 BOTTLE in 1 CARTON (45802-104-01) / 240 SPRAY in 1 BOTTLEMarketed from Jun 14, 2017

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): olopatadine hydrochloride
Generic name (nonproprietary): olopatadine hydrochloride
Active ingredients: Olopatadine hydrochloride — 665 ug/1
Dosage form: Spray
Route: Nasal
Labeler: Padagis Israel Pharmaceuticals Ltd
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 202853
Marketing start: Jun 14, 2017
Listing expires: Dec 31, 2026
Other FDA classes: Decreased Histamine Release (Physiologic effect)Histamine H1 Receptor Antagonists (Mechanism)
Identifiers: Product ID 45802-104_dca15bfb-d84a-46e3-800c-3e3e1eaa6967SPL ID dca15bfb-d84a-46e3-800c-3e3e1eaa6967SPL set ID 126ff6eb-62ae-46f2-ab1e-7ac19346c36bRxCUI 1797895UNII 2XG66W44KF
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. Nasal products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N445802010401 followed by a unit qualifier and the quantity

Package 45802-0104-01. 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 Sep 1, 2023.

Indications (excerpt from the label)

Olopatadine hydrochloride nasal spray is indicated for the relief of the symptoms of seasonal allergic rhinitis in adults and pediatric patients 6 years of age and older. Olopatadine hydrochloride nasal spray is an H 1 receptor antagonist indicated for the relief of the symptoms of seasonal allergic rhinitis in adults and pediatric patients 6 years of age and older ( 1 ).

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 202853

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

FDA NDC Directory listings under ANDA 202853
Product	Strength	Form · route	Labeler	Product NDC
olopatadine hydrochloride	Olopatadine hydrochloride 665 ug/1	SprayNasal	Bryant Ranch Prepack	63629-8434
olopatadine hydrochloride	Olopatadine hydrochloride 665 ug/1	SprayNasal	Bryant Ranch Prepack	72162-1390