NDC codes

FDA NDC Directory
Product NDC (as listed)0536-1307Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00536-1307Add 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
0536-1307-2300536130723005361307231 BOTTLE, DROPPER in 1 CARTON (0536-1307-23) / 2.5 mL in 1 BOTTLE, DROPPERMarketed from Jan 15, 2021

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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/ drops
Route
Ophthalmic
Labeler
Rugby LaboratoriesNDC labeler code 0536
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 0536-1307_ebf26e25-d073-ca39-6b0b-dec0fa2c2107SPL ID ebf26e25-d073-ca39-6b0b-dec0fa2c2107SPL set ID 95424539-7883-2da3-8a46-3d1a19259e15RxCUI 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

N400536130723 followed by a unit qualifier and the quantity

Package 00536-1307-23. 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 0536-1307

What is NDC 0536-1307?
0536-1307 is the product NDC for Olopatadine Hydrochloride, Olopatadine hydrochloride 2 mg/mL solution/ drops, listed with the FDA by Rugby Laboratories. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Olopatadine Hydrochloride.
What is the active ingredient?
Olopatadine hydrochloride.
Who is the labeler?
Rugby Laboratories, NDC labeler code 0536. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Olopatadine Hydrochloride?
63 other product NDCs are listed under this name. See all Olopatadine Hydrochloride 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 Olopatadine Hydrochloride NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Olopatadine HydrochlorideOlopatadine hydrochloride 2 mg/mLSolutionOphthalmicYYBA CORP73581-71373581-0713-02
Olopatadine HydrochlorideOlopatadine hydrochloride 2 mg/mLSolutionOphthalmicYYBA CORP73581-71273581-0712-02
Olopatadine Hydrochlorideolopatadine hydrochloride ophthalmicOlopatadine hydrochloride 1 mg/mLSolutionOphthalmicAmerisourceBergen Drug Corp46122-82346122-0823-29
Olopatadine HydrochlorideOlopatadine hydrochloride 2 mg/mLSolutionOphthalmicAmerisourceBergen Drug Corp46122-82446122-0824-29
Olopatadine HydrochlorideOlopatadine hydrochloride 2 mg/mLSolutionOphthalmicYYBA Corp73581-70973581-0709-02
Olopatadine HydrochlorideOlopatadine hydrochloride 2 mg/mLSolutionOphthalmicWALGREEN COMPANY0363-086900363-0869-0100363-0869-02
Olopatadine HydrochlorideOlopatadine hydrochloride 2 mg/mLSolutionOphthalmicBluePoint Laboratories68001-67468001-0674-92
Olopatadine HydrochlorideOlopatadine hydrochloride 1 mg/mLSolution/ dropsOphthalmicAllegiant Health69168-48069168-0480-0269168-0480-65
olopatadine hydrochlorideOlopatadine hydrochloride 2 mg/mLSolutionOphthalmicRising Pharma Holdings, Inc.16571-86116571-0861-25
olopatadine hydrochlorideOlopatadine hydrochloride 1 mg/mLSolutionOphthalmicRising Pharma Holdings, Inc.16571-88216571-0882-05

All 64 Olopatadine Hydrochloride NDCs

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 Reliefolopatadine hclOlopatadine hydrochloride 2 mg/mLSolution/ dropsOphthalmicCARDINAL HEALTH 110, LLC. DBA LEADER70000-0053
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 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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