NDC codes

FDA NDC Directory
Product NDC (as listed)70000-0053Labeler and product segments. Claims need a package NDC.
Product NDC at billing width70000-0053Add 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
70000-0053-170000005301700000053011 BOTTLE, DROPPER in 1 CARTON (70000-0053-1) / 2.5 mL in 1 BOTTLE, DROPPERMarketed from Jan 15, 2021

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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)
Eye Allergy Itch Relief
Generic name (nonproprietary)
olopatadine hcl
Active ingredients
Olopatadine hydrochloride — 2 mg/mL
Dosage form
Solution/ drops
Route
Ophthalmic
Labeler
CARDINAL HEALTH 110, LLC. DBA LEADERNDC labeler code 70000
Product type
Over-the-counter drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 209752
Marketing start
Listing expires
Other FDA classes
Decreased Histamine Release (Physiologic effect)Histamine H1 Receptor Antagonists (Mechanism)
Identifiers
Product ID 70000-0053_ece56087-7def-0eb9-13d3-b187763b7f7bSPL ID ece56087-7def-0eb9-13d3-b187763b7f7bSPL set ID 135bb2de-b2c0-6f0c-6204-3acbb48dcfbdRxCUI 1111343UNII 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

N470000005301 followed by a unit qualifier and the quantity

Package 70000-0053-01. 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)

About NDC 70000-0053

What is NDC 70000-0053?
70000-0053 is the product NDC for Eye Allergy Itch Relief (olopatadine hcl), Olopatadine hydrochloride 2 mg/mL solution/ drops, listed with the FDA by CARDINAL HEALTH 110, LLC. DBA LEADER. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Eye Allergy Itch Relief (Olopatadine HCl).
What is the active ingredient?
Olopatadine hydrochloride.
Who is the labeler?
CARDINAL HEALTH 110, LLC. DBA LEADER, NDC labeler code 70000. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Eye Allergy Itch Relief?
5 other product NDCs are listed under this name. See all Eye Allergy Itch Relief NDCs.
Is there a related HCPCS / J-code?
Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Eye Allergy Itch Relief NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Eye Allergy Itch Reliefolopatadine hydrochlorideOlopatadine hydrochloride 7 mg/mLSolution/ dropsOphthalmicTARGET CORPORATION82442-02782442-0027-2582442-0027-50
Eye Allergy Itch ReliefOlopatadine hydrochloride 2 mg/mLSolution/ dropsOphthalmicAllegiant Health69168-49569168-0495-77
Eye Allergy Itch Reliefolopatadine hydrochloride ophthalmicOlopatadine hydrochloride 7 mg/mLSolutionOphthalmicWalgreen Company0363-132500363-1325-0100363-1325-02
Eye Allergy Itch Reliefolopatadine hydrochlorideOlopatadine hydrochloride 7 mg/mLSolution/ dropsOphthalmicCARDINAL HEALTH 110, LLC. DBA LEADER70000-074670000-0746-01
Eye Allergy Itch Reliefolopatadine hydrochloride ophthalmicOlopatadine hydrochloride 7 mg/mLSolutionOphthalmicDr. Reddy's Laboratories Inc.75907-34375907-0343-25

Other NDCs under ANDA 209752

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

FDA NDC Directory listings under ANDA 209752
ProductStrengthForm · routeLabelerProduct NDC
Allergy Relief Eye Dropsolopatadine hydrochloride ophthalmicOlopatadine hydrochloride 2 mg/mLSolutionOphthalmicCVS Pharmacy51316-675
CVS Eye Allergy Itch Relief Once Dailyolopatadine hydrochloride ophthalmicOlopatadine hydrochloride 2 mg/mLSolutionOphthalmicCVS Health Corp69842-269
Eye Allergy Itch Relief Once Daily Reliefolopatadine hydrochloride ophthalmicOlopatadine hydrochloride 2 mg/mLSolutionOphthalmicDr. Reddy's Laboratories Inc.43598-827
Eye Allergy Itch Relief Once Daily Reliefolopatadine hydrochloride ophthalmicOlopatadine hydrochloride 2 mg/mLSolutionOphthalmicStrategic Sourcing Services LLC70677-1155
Olopatadine HydrochlorideOlopatadine hydrochloride 2 mg/mLSolution/ dropsOphthalmicRugby Laboratories0536-1307
Olopatadine Hydrochloride Ophthalmic Solutionolopatadine hydrochloride ophthalmicOlopatadine hydrochloride 2 mg/mLSolutionOphthalmicWalgreens Company0363-7131
Olopatadine Hydrochloride Ophthalmic Solutionolopatadine hydrochloride ophthalmicOlopatadine hydrochloride 2 mg/mLSolutionOphthalmicTarget Corporation11673-688
Olopatadine Hydrochloride Ophthalmic Solutionolopatadine hydrochloride ophthalmicOlopatadine hydrochloride 2 mg/mLSolutionOphthalmicRite Aid Corporation11822-9975
Olopatadine Hydrochloride Ophthalmic Solutionolopatadine hydrochloride ophthalmicOlopatadine hydrochloride 2 mg/mLSolutionOphthalmicAlbertsons Companies21130-105
Olopatadine Hydrochloride Ophthalmic Solutionolopatadine hydrochloride ophthalmicOlopatadine hydrochloride 2 mg/mLSolutionOphthalmicChain Drug Marketing Association INC63868-821
Olopatadine Hydrochloride Ophthalmic Solutionolopatadine hydrochloride ophthalmicOlopatadine hydrochloride 2 mg/mLSolutionOphthalmicGland Pharma Limited68083-231
Olopatadine Hydrochloride Ophthalmic Solutionolopatadine hydrochloride ophthalmicOlopatadine hydrochloride 2 mg/mLSolutionOphthalmicChain Drug Marketing Association INC83324-120
Olopatadine Hydrochloride Ophthalmic Solution Once Dailyolopatadine hydrochloride ophthalmicOlopatadine hydrochloride 2 mg/mLSolutionOphthalmicDOLGENCORP, LLC55910-137
Once Daily Reliefolopatadine hydrochloride ophthalmic solutionOlopatadine hydrochloride 2 mg/mLSolutionOphthalmicH E B37808-045

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