NDC codes

FDA NDC Directory
Product NDC (as listed)0065-4274Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00065-4274Add 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
0065-4274-01000654274011 BOTTLE, PLASTIC in 1 CARTON (0065-4274-01) / 5 mL in 1 BOTTLE, PLASTICMarketed from Feb 25, 2020

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)
Pataday Twice A Day Relief
Generic name (nonproprietary)
olopatadine hydrochloride
Active ingredients
Olopatadine hydrochloride — 1 mg/mL
Dosage form
Solution
Route
Ophthalmic
Labeler
Alcon Laboratories, Inc.NDC labeler code 0065
Product type
Over-the-counter drug
Marketing category
NDA — New Drug ApplicationApplication NDA 020688
Marketing start
Listing expires
Other FDA classes
Decreased Histamine Release (Physiologic effect)Histamine H1 Receptor Antagonists (Mechanism)
Identifiers
Product ID 0065-4274_c2f804cb-30d1-40d1-b48e-06889a3e0490SPL ID c2f804cb-30d1-40d1-b48e-06889a3e0490SPL set ID b7a24375-25df-4405-aa7c-34c46af51194RxCUI 1111339, 2281304UNII 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

N400065427401 followed by a unit qualifier and the quantity

Package 00065-4274-01. 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 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)

About NDC 0065-4274

What is NDC 0065-4274?
0065-4274 is the product NDC for Pataday Twice A Day Relief (olopatadine hydrochloride), Olopatadine hydrochloride 1 mg/mL solution, listed with the FDA by Alcon Laboratories, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Pataday Twice A Day Relief (Olopatadine hydrochloride).
What is the active ingredient?
Olopatadine hydrochloride.
Who is the labeler?
Alcon Laboratories, Inc., NDC labeler code 0065. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Pataday Twice A Day Relief?
None: this is the only finished product listed under this name.
Is there a related HCPCS / J-code?
Not in Med-Code's curated HCPCS directory. See Billing references above.

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