Over-the-counter drug · ANDA

Olopatadine Hydrochloride NDC 58602-013

Olopatadine hydrochloride 2 mg/mL · Solution · Ophthalmic · Aurohealth LLC

NDC codes

FDA NDC Directory
Product NDC (as listed)58602-013Labeler and product segments. Claims need a package NDC.
Product NDC at billing width58602-0013Add 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
58602-013-39586020013391 BOTTLE, PLASTIC in 1 CARTON (58602-013-39) / 2.5 mL in 1 BOTTLE, PLASTICMarketed from Jul 15, 2020
58602-013-41586020013412 BOTTLE, PLASTIC in 1 CARTON (58602-013-41) / 2.5 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 — 2 mg/mL
Dosage form
Solution
Route
Ophthalmic
Product type
Over-the-counter drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 209995
Marketing start
Listing expires
Other FDA classes
Decreased Histamine Release (Physiologic effect)Histamine H1 Receptor Antagonists (Mechanism)
Identifiers
Product ID 58602-013_223ca879-71fd-4a04-94d1-ae8aae206948SPL ID 223ca879-71fd-4a04-94d1-ae8aae206948SPL set ID 5f9e93e7-ff12-484d-add8-4f834193c1c6RxCUI 1111343UNII 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

N458602001339 followed by a unit qualifier and the quantity

Package 58602-0013-39. 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 209995

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

FDA NDC Directory listings under ANDA 209995
ProductStrengthForm · routeLabelerProduct NDC
Olopatadine HydrochlorideOlopatadine hydrochloride 2 mg/mLSolutionOphthalmicTOPCO ASSOCIATES LLC76162-044
Olopatadine HydrochlorideOlopatadine hydrochloride 2 mg/mLSolutionOphthalmicKroger Company30142-026
Olopatadine HydrochlorideOlopatadine hydrochloride 2 mg/mLSolutionOphthalmicRITE AID CORPORATION11822-0063
Olopatadine HydrochlorideOlopatadine hydrochloride 2 mg/mLSolutionOphthalmicAurohealth LLC58602-007
Olopatadine HydrochlorideOlopatadine hydrochloride 2 mg/mLSolutionOphthalmicAurohealth LLC58602-010
Olopatadine HydrochlorideOlopatadine hydrochloride 2 mg/mLSolutionOphthalmicWal-Mart Stores, Inc.79903-001
Olopatadine HydrochlorideOlopatadine hydrochloride 2 mg/mLSolutionOphthalmicHarris Teeter72036-009
Olopatadine HydrochlorideOlopatadine hydrochloride 2 mg/mLSolutionOphthalmicBluePoint Laboratories68001-530
Olopatadine HydrochlorideOlopatadine hydrochloride 2 mg/mLSolutionOphthalmicBest Choice63941-024
Olopatadine HydrochlorideOlopatadine hydrochloride 2 mg/mLSolutionOphthalmicMeijer79481-1001
Olopatadine HydrochlorideOlopatadine hydrochloride 2 mg/mLSolutionOphthalmicRetail Business Services, LLC.72476-851
Olopatadine HydrochlorideOlopatadine hydrochloride 2 mg/mLSolutionOphthalmicA-S Medication Solutions50090-5613
Olopatadine HydrochlorideOlopatadine hydrochloride 2 mg/mLSolutionOphthalmicAllwell Health Inc80539-001
Olopatadine HydrochlorideOlopatadine hydrochloride 2 mg/mLSolutionOphthalmicWALGREEN CO.0363-8022
Olopatadine HydrochlorideOlopatadine hydrochloride 2 mg/mLSolutionOphthalmicAmerisource Bergen46122-671
Olopatadine HydrochlorideOlopatadine hydrochloride 2 mg/mLSolutionOphthalmicYYBA CORP73581-713

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