NDC codes

FDA NDC Directory
Product NDC (as listed)51316-567Labeler and product segments. Claims need a package NDC.
Product NDC at billing width51316-0567Add 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 NDC11-digit (billing)PackageCopy
51316-567-01513160567011 BOTTLE in 1 CARTON (51316-567-01) / 2.5 mL in 1 BOTTLEMarketed from Jan 15, 2026

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 Ophthalmic Solution
Generic name (nonproprietary)
olopatadine hydrochloride ophthalmic
Active ingredients
Olopatadine hydrochloride7 mg/mL
Dosage form
Solution
Route
Ophthalmic
Product type
Over-the-counter drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 213514
Marketing start
Listing expires
Other FDA classes
Decreased Histamine Release (Physiologic effect)Histamine H1 Receptor Antagonists (Mechanism)
Identifiers
Product ID 51316-567_3fe3c75e-cb1f-bb27-8b6e-6f34dee09a0eSPL ID 3fe3c75e-cb1f-bb27-8b6e-6f34dee09a0eSPL set ID 56d56cb8-b04c-5f48-b0c3-5639a79fd2c5RxCUI 1601086UNII 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

N451316056701 followed by a unit qualifier and the quantity

Package 51316-0567-01. 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 .

Indications (excerpt from the label)

USE temporarily relieves itchy 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 213514

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

FDA NDC Directory listings under ANDA 213514
ProductStrengthForm · routeLabelerProduct NDC
Olopatadine HClolopatadine hydrochlorideOlopatadine hydrochloride 7 mg/mLSolution/ dropsOphthalmicRugby Laboratories0536-1478
Olopatadine Hydrochloride Ophthalmic Solutionolopatadine hydrochloride ophthalmicOlopatadine hydrochloride 7 mg/mLSolutionOphthalmicGland Pharma Limited68083-398
Eye Allergy Itch Reliefolopatadine hydrochlorideOlopatadine hydrochloride 7 mg/mLSolution/ dropsOphthalmicTARGET CORPORATION82442-027
Olopatadine Hydrochloride Ophthalmic Solutionolopatadine hydrochlorideOlopatadine hydrochloride 7 mg/mLSolution/ dropsOphthalmicDr. Reddy's Laboratories Inc.75907-285
Eye Allergy Itch Reliefolopatadine hydrochloride ophthalmicOlopatadine hydrochloride 7 mg/mLSolutionOphthalmicDr. Reddy's Laboratories Inc.75907-343
Eye Allergy Itch Reliefolopatadine hydrochlorideOlopatadine hydrochloride 7 mg/mLSolution/ dropsOphthalmicCARDINAL HEALTH 110, LLC. DBA LEADER70000-0746
Allergy Relief Eye Dropsolopatadine hydrochloride ophthalmicOlopatadine hydrochloride 7 mg/mLSolutionOphthalmicCVS Pharmacy51316-633
Eye Allergy Itch Reliefolopatadine hydrochloride ophthalmicOlopatadine hydrochloride 7 mg/mLSolutionOphthalmicWalgreen Company0363-1325

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