Over-the-counter drug · NDA
Pataday Once Daily Relief (Olopatadine hydrochloride) NDC 0065-0816
Olopatadine hydrochloride 7 mg/mL · Solution · Ophthalmic · Alcon Laboratories, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0065-0816-01 | 00065081601 | 2 BOTTLE, PLASTIC in 1 CARTON (0065-0816-01) / 2.5 mL in 1 BOTTLE, PLASTICMarketed from Jan 4, 2021 | |
| 0065-0816-02 | 00065081602 | 1 BOTTLE, PLASTIC in 1 CARTON (0065-0816-02) / .5 mL in 1 BOTTLE, PLASTICMarketed from Jan 4, 2021 | |
| 0065-0816-04 | 00065081604 | 1 BOTTLE, PLASTIC in 1 CARTON (0065-0816-04) / 2.5 mL in 1 BOTTLE, PLASTICMarketed from Sep 1, 2020 | |
| 0065-0816-12 | 00065081612 | 3 BOTTLE, PLASTIC in 1 CARTON (0065-0816-12) / 2.5 mL in 1 BOTTLE, PLASTICMarketed from Jan 24, 2022 |
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 Once Daily Relief
- Generic name (nonproprietary)
- olopatadine hydrochloride
- Active ingredients
- Olopatadine hydrochloride — 7 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 206276
- Marketing start
- Listing expires
- Other FDA classes
- Decreased Histamine Release (Physiologic effect)Histamine H1 Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 0065-0816_d735b7f6-185e-4fbb-a640-0f8aa8c57f45SPL ID d735b7f6-185e-4fbb-a640-0f8aa8c57f45SPL set ID 6d07a5d6-265c-4735-97b3-8a2575b276cbRxCUI 1601086, 2474007UNII 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
N400065081601followed by a unit qualifier and the quantityPackage 00065-0816-01. 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.
About NDC 0065-0816
- What is NDC 0065-0816?
- 0065-0816 is the product NDC for Pataday Once Daily Relief (olopatadine hydrochloride), Olopatadine hydrochloride 7 mg/mL solution, listed with the FDA by Alcon Laboratories, Inc.. It has 4 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Pataday Once Daily 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 Once Daily Relief?
- 1 other product NDC are listed under this name. See all Pataday Once Daily Relief NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Pataday Once Daily Relief products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Pataday Once Daily Reliefolopatadine hydrochloride | Olopatadine hydrochloride 2 mg/mL | SolutionOphthalmic | Alcon Laboratories, Inc. | 0065-8150 | 00065-8150-0100065-8150-0300065-8150-04+1 more |