Olopatadine Hydrochloride NDC 46708-709

NDC codes

FDA NDC Directory

Product NDC (as listed)46708-709Labeler and product segments. Claims need a package NDC.

Product NDC at billing width46708-0709Add 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
46708-709-05	46708070905	1 BOTTLE in 1 CARTON (46708-709-05) / 5 mL in 1 BOTTLEMarketed from Feb 18, 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): Olopatadine Hydrochloride
Generic name (nonproprietary): olopatadine hydrochloride
Active ingredients: Olopatadine hydrochloride — 1 mg/mL
Dosage form: Solution/ drops
Route: Ophthalmic
Labeler: Alembic Pharmaceuticals Limited
Product type: Over-the-counter drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 209919
Marketing start: Feb 18, 2021
Listing expires: Dec 31, 2026
Other FDA classes: Decreased Histamine Release (Physiologic effect)Histamine H1 Receptor Antagonists (Mechanism)
Identifiers: Product ID 46708-709_3277e355-0507-4ece-89dc-2b550f2b4cdeSPL ID 3277e355-0507-4ece-89dc-2b550f2b4cdeSPL set ID ac82e6ea-5694-4f48-819b-91fc567ceaf1RxCUI 1111339UNII 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. Ophthalmic products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N446708070905 followed by a unit qualifier and the quantity

Package 46708-0709-05. 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 Jun 11, 2024.

Indications (excerpt from the label)

USE(S) temporarily relieves itchy red eyes due to pollen, ragweed, grass, animal hair and dander

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 209919

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

FDA NDC Directory listings under ANDA 209919
Product	Strength	Form · route	Labeler	Product NDC
Olopatadine Hydrochloride	Olopatadine hydrochloride 1 mg/mL	Solution/ dropsOphthalmic	Alembic Pharmaceuticals Inc.	62332-709
Olopatadine Hydrochloride	Olopatadine hydrochloride 1 mg/mL	Solution/ dropsOphthalmic	Alembic Pharmaceuticals Inc.	62332-501