Over-the-counter drug · ANDA

Olopatadine Hydrochloride NDC 76162-020

Olopatadine hydrochloride 1 mg/mL · Solution · Ophthalmic · TOPCO ASSOCIATES LLC

NDC codes

FDA NDC Directory
Product NDC (as listed)76162-020Labeler and product segments. Claims need a package NDC.
Product NDC at billing width76162-0020Add 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
76162-020-40761620020401 BOTTLE, PLASTIC in 1 CARTON (76162-020-40) / 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 76162-020_a413aedd-c114-40a3-bfad-1f9db0565b0fSPL ID a413aedd-c114-40a3-bfad-1f9db0565b0fSPL set ID f5bddc73-1899-b5f0-e053-2995a90ab98fRxCUI 1111339UNII 2XG66W44KFUPC 0036800001169
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

N476162002040 followed by a unit qualifier and the quantity

Package 76162-0020-40. 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/mLSolutionOphthalmicAmerisource Bergen46122-672
Olopatadine HydrochlorideOlopatadine hydrochloride 2 mg/mLSolutionOphthalmicYYBA CORP73581-712
Olopatadine HydrochlorideOlopatadine hydrochloride 1 mg/mLSolutionOphthalmicA-S Medication Solutions50090-6341
Olopatadine HydrochlorideOlopatadine hydrochloride 1 mg/mLSolutionOphthalmicRITE AID CORPORATION11822-0064
Olopatadine HydrochlorideOlopatadine hydrochloride 1 mg/mLSolutionOphthalmicWal-Mart Stores, Inc.79903-000
Olopatadine HydrochlorideOlopatadine hydrochloride 1 mg/mLSolutionOphthalmicKroger Company30142-064
Olopatadine HydrochlorideOlopatadine hydrochloride 1 mg/mLSolutionOphthalmicAurohealth LLC58602-009
Olopatadine HydrochlorideOlopatadine hydrochloride 1 mg/mLSolutionOphthalmicAurohealth LLC58602-006
Olopatadine HydrochlorideOlopatadine hydrochloride 1 mg/mLSolutionOphthalmicAurohealth LLC58602-012
Olopatadine HydrochlorideOlopatadine hydrochloride 1 mg/mLSolutionOphthalmicMeijer79481-1000
Olopatadine HydrochlorideOlopatadine hydrochloride 1 mg/mLSolutionOphthalmicHarris Teeter72036-008
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

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