Over-the-counter drug · ANDA
Olopatadine Hydrochloride NDC 0536-1445
olopatadine hydrochloride ophthalmic solution · Olopatadine hydrochloride 1 mg/mL · Solution/ drops · Ophthalmic · RUGBY LABORATORIES
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0536-1445-40 | 0053614454000536144540 | 1 BOTTLE in 1 CARTON (0536-1445-40) / 5 mL in 1 BOTTLEMarketed from Apr 15, 2025 |
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 ophthalmic solution
- Active ingredients
- Olopatadine hydrochloride — 1 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 206046
- Marketing start
- Listing expires
- Other FDA classes
- Decreased Histamine Release (Physiologic effect)Histamine H1 Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 0536-1445_5b8db4fc-fc76-431b-e063-6294a90a51f8SPL ID 5b8db4fc-fc76-431b-e063-6294a90a51f8
- 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
N400536144540followed by a unit qualifier and the quantityPackage 00536-1445-40. 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
The FDA listing for this product does not reference a label (SPL) set.
About NDC 0536-1445
- What is NDC 0536-1445?
- 0536-1445 is the product NDC for Olopatadine Hydrochloride, Olopatadine hydrochloride 1 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 (Olopatadine Hydrochloride Ophthalmic Solution).
- 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.
Related NDCs: other Olopatadine Hydrochloride 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 Hydrochloride | Olopatadine hydrochloride 2 mg/mL | SolutionOphthalmic | YYBA CORP | 73581-713 | 73581-0713-02 |
| Olopatadine Hydrochloride | Olopatadine hydrochloride 2 mg/mL | SolutionOphthalmic | YYBA CORP | 73581-712 | 73581-0712-02 |
| Olopatadine Hydrochlorideolopatadine hydrochloride ophthalmic | Olopatadine hydrochloride 1 mg/mL | SolutionOphthalmic | AmerisourceBergen Drug Corp | 46122-823 | 46122-0823-29 |
| Olopatadine Hydrochloride | Olopatadine hydrochloride 2 mg/mL | SolutionOphthalmic | AmerisourceBergen Drug Corp | 46122-824 | 46122-0824-29 |
| Olopatadine Hydrochloride | Olopatadine hydrochloride 2 mg/mL | SolutionOphthalmic | YYBA Corp | 73581-709 | 73581-0709-02 |
| Olopatadine Hydrochloride | Olopatadine hydrochloride 2 mg/mL | SolutionOphthalmic | WALGREEN COMPANY | 0363-0869 | 00363-0869-0100363-0869-02 |
| Olopatadine Hydrochloride | Olopatadine hydrochloride 2 mg/mL | SolutionOphthalmic | BluePoint Laboratories | 68001-674 | 68001-0674-92 |
| Olopatadine Hydrochloride | Olopatadine hydrochloride 1 mg/mL | Solution/ dropsOphthalmic | Allegiant Health | 69168-480 | 69168-0480-0269168-0480-65 |
| olopatadine hydrochloride | Olopatadine hydrochloride 2 mg/mL | SolutionOphthalmic | Rising Pharma Holdings, Inc. | 16571-861 | 16571-0861-25 |
| olopatadine hydrochloride | Olopatadine hydrochloride 1 mg/mL | SolutionOphthalmic | Rising Pharma Holdings, Inc. | 16571-882 | 16571-0882-05 |
Other NDCs under ANDA 206046
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 |
|---|---|---|---|---|
| Equate Olopatadine Hydrochloride Ophthalmic Solutionolopatadine hydrochloride ophthalmic solution | Olopatadine hydrochloride 1 mg/mL | SolutionOphthalmic | WAL-MART STORES, INC., | 79903-319 |
| Leader Olopatadine Hydrochloride Ophthalmic Solutionolopatadine hydrochloride ophthalmic solution | Olopatadine hydrochloride 1 mg/mL | SolutionOphthalmic | CARDINAL HEALTH | 70000-0717 |
| Olopatadine Hydrochloride | Olopatadine hydrochloride 1 mg/mL | SolutionOphthalmic | TARGET CORPORATION | 82442-966 |
| Olopatadine Hydrochloride Ophthalmic Solution | Olopatadine hydrochloride 1 mg/mL | SolutionOphthalmic | WALGREEN COMPANY | 0363-0867 |
| Olopatadine Hydrochloride Ophthalmic Solution | Olopatadine hydrochloride 1 mg/mL | SolutionOphthalmic | Bausch & Lomb Incorporated | 24208-966 |