Over-the-counter drug · ANDA
Olopatadine HCl (Olopatadine hydrochloride) NDC 0536-1478
Olopatadine hydrochloride 7 mg/mL · Solution/ drops · Ophthalmic · Rugby Laboratories
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0536-1478-23 | 0053614782300536147823 | 1 BOTTLE, DROPPER in 1 CARTON (0536-1478-23) / 2.5 mL in 1 BOTTLE, DROPPERMarketed from Jan 15, 2026 |
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 HCl
- Generic name (nonproprietary)
- olopatadine hydrochloride
- Active ingredients
- Olopatadine hydrochloride — 7 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 213514
- Marketing start
- Listing expires
- Other FDA classes
- Decreased Histamine Release (Physiologic effect)Histamine H1 Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 0536-1478_abf48a68-28f8-d2eb-1a84-acf9159f2f2fSPL ID abf48a68-28f8-d2eb-1a84-acf9159f2f2fSPL set ID edb068e2-1835-483e-e59c-bcbe13b66d76RxCUI 1601086UNII 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
N400536147823followed by a unit qualifier and the quantityPackage 00536-1478-23. 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.
About NDC 0536-1478
- What is NDC 0536-1478?
- 0536-1478 is the product NDC for Olopatadine HCl (olopatadine hydrochloride), Olopatadine hydrochloride 7 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 HCl (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 HCl?
- 1 other product NDC are listed under this name. See all Olopatadine HCl NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Olopatadine HCl products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Olopatadine Hcl | Olopatadine hydrochloride 1 mg/mL | Solution/ dropsOphthalmic | Sola Pharmaceuticals | 70512-520 | 70512-0520-05 |
Other NDCs under ANDA 213514
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Allergy Relief Eye Dropsolopatadine hydrochloride ophthalmic | Olopatadine hydrochloride 7 mg/mL | SolutionOphthalmic | CVS Pharmacy | 51316-633 |
| Eye Allergy Itch Reliefolopatadine hydrochloride ophthalmic | Olopatadine hydrochloride 7 mg/mL | SolutionOphthalmic | Walgreen Company | 0363-1325 |
| Eye Allergy Itch Reliefolopatadine hydrochloride | Olopatadine hydrochloride 7 mg/mL | Solution/ dropsOphthalmic | CARDINAL HEALTH 110, LLC. DBA LEADER | 70000-0746 |
| Eye Allergy Itch Reliefolopatadine hydrochloride ophthalmic | Olopatadine hydrochloride 7 mg/mL | SolutionOphthalmic | Dr. Reddy's Laboratories Inc. | 75907-343 |
| Eye Allergy Itch Reliefolopatadine hydrochloride | Olopatadine hydrochloride 7 mg/mL | Solution/ dropsOphthalmic | TARGET CORPORATION | 82442-027 |
| Olopatadine Hydrochloride Ophthalmic Solutionolopatadine hydrochloride ophthalmic | Olopatadine hydrochloride 7 mg/mL | SolutionOphthalmic | CVS Pharmacy | 51316-567 |
| Olopatadine Hydrochloride Ophthalmic Solutionolopatadine hydrochloride ophthalmic | Olopatadine hydrochloride 7 mg/mL | SolutionOphthalmic | Gland Pharma Limited | 68083-398 |