Over-the-counter drug · ANDA

Olopatadine Hydrochloride NDC 58602-009

Olopatadine hydrochloride 1 mg/mL · Solution · Ophthalmic · Aurohealth LLC

NDC codes

FDA NDC Directory
Product NDC (as listed)58602-009Labeler and product segments. Claims need a package NDC.
Product NDC at billing width58602-0009Add 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
58602-009-40586020009401 BOTTLE, PLASTIC in 1 CARTON (58602-009-40) / 5 mL in 1 BOTTLE, PLASTICMarketed from Jul 15, 2020

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
Route
Ophthalmic
Product type
Over-the-counter drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 204812
Marketing start
Listing expires
Other FDA classes
Decreased Histamine Release (Physiologic effect)Histamine H1 Receptor Antagonists (Mechanism)
Identifiers
Product ID 58602-009_0fabfa45-4924-4b70-aae0-9cc26152a852SPL ID 0fabfa45-4924-4b70-aae0-9cc26152a852SPL set ID c12af544-995a-43d7-8404-94906d52fa07RxCUI 1111339UNII 2XG66W44KF
Pharmacologic class
Histamine-1 Receptor Inhibitor

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

N458602000940 followed by a unit qualifier and the quantity

Package 58602-0009-40. 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

Current FDA label (SPL), effective .

Indications (excerpt from the label)

Uses temporarily relieves itchy and 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 204812

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

FDA NDC Directory listings under ANDA 204812
ProductStrengthForm · routeLabelerProduct NDC
Olopatadine HydrochlorideOlopatadine hydrochloride 1 mg/mLSolutionOphthalmicRITE AID CORPORATION11822-0064
Olopatadine HydrochlorideOlopatadine hydrochloride 1 mg/mLSolutionOphthalmicKroger Company30142-064
Olopatadine HydrochlorideOlopatadine hydrochloride 1 mg/mLSolutionOphthalmicAurohealth LLC58602-006
Olopatadine HydrochlorideOlopatadine hydrochloride 1 mg/mLSolutionOphthalmicWal-Mart Stores, Inc.79903-000
Olopatadine HydrochlorideOlopatadine hydrochloride 1 mg/mLSolutionOphthalmicAurohealth LLC58602-012
Olopatadine HydrochlorideOlopatadine hydrochloride 1 mg/mLSolutionOphthalmicHarris Teeter72036-008
Olopatadine HydrochlorideOlopatadine hydrochloride 1 mg/mLSolutionOphthalmicMeijer79481-1000
Olopatadine HydrochlorideOlopatadine hydrochloride 1 mg/mLSolutionOphthalmicRetail Business Services, LLC.72476-852
Olopatadine HydrochlorideOlopatadine hydrochloride 1 mg/mLSolutionOphthalmicSportpharm LLC85766-111
Olopatadine HydrochlorideOlopatadine hydrochloride 1 mg/mLSolutionOphthalmicWALGREEN CO.0363-0200
Olopatadine HydrochlorideOlopatadine hydrochloride 1 mg/mLSolutionOphthalmicAmerisource Bergen46122-672
Olopatadine HydrochlorideOlopatadine hydrochloride 1 mg/mLSolutionOphthalmicTOPCO ASSOCIATES LLC76162-020
Olopatadine HydrochlorideOlopatadine hydrochloride 2 mg/mLSolutionOphthalmicYYBA CORP73581-712
Olopatadine HydrochlorideOlopatadine hydrochloride 1 mg/mLSolutionOphthalmicA-S Medication Solutions50090-6341

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