Over-the-counter drug · ANDA
Olopatadine Hydrochloride NDC 76162-044
Olopatadine hydrochloride 2 mg/mL · Solution · Ophthalmic · TOPCO ASSOCIATES LLC
NDC codes
FDA NDC DirectoryProduct NDC (as listed)76162-044Labeler and product segments. Claims need a package NDC.
Product NDC at billing width76162-0044Add the package segment from the table below.
| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 76162-044-39 | 7616200443976162004439 | 1 BOTTLE, PLASTIC in 1 CARTON (76162-044-39) / 2.5 mL in 1 BOTTLE, PLASTICMarketed from Jul 15, 2020 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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
- Route
- Ophthalmic
- Labeler
- TOPCO ASSOCIATES LLCNDC labeler code 76162
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 209995
- Marketing start
- Listing expires
- Other FDA classes
- Decreased Histamine Release (Physiologic effect)Histamine H1 Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 76162-044_4dcb6552-c458-40c0-80f9-78ca2c668dfaSPL ID 4dcb6552-c458-40c0-80f9-78ca2c668dfaSPL set ID 1932ee68-43a5-6474-e063-6294a90aacafRxCUI 1111343UNII 2XG66W44KFUPC 0036800001176
- 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
N476162004439followed by a unit qualifier and the quantityPackage 76162-0044-39. 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 76162-044
- What is NDC 76162-044?
- 76162-044 is the product NDC for Olopatadine Hydrochloride, Olopatadine hydrochloride 2 mg/mL solution, listed with the FDA by TOPCO ASSOCIATES LLC. 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?
- TOPCO ASSOCIATES LLC, NDC labeler code 76162. 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 209995
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 |
|---|---|---|---|---|
| Olopatadine Hydrochloride | Olopatadine hydrochloride 2 mg/mL | SolutionOphthalmic | WALGREEN CO. | 0363-8022 |
| Olopatadine Hydrochloride | Olopatadine hydrochloride 2 mg/mL | SolutionOphthalmic | RITE AID CORPORATION | 11822-0063 |
| Olopatadine Hydrochloride | Olopatadine hydrochloride 2 mg/mL | SolutionOphthalmic | Kroger Company | 30142-026 |
| Olopatadine Hydrochloride | Olopatadine hydrochloride 2 mg/mL | SolutionOphthalmic | Amerisource Bergen | 46122-671 |
| Olopatadine Hydrochloride | Olopatadine hydrochloride 2 mg/mL | SolutionOphthalmic | A-S Medication Solutions | 50090-5613 |
| Olopatadine Hydrochloride | Olopatadine hydrochloride 2 mg/mL | SolutionOphthalmic | Aurohealth LLC | 58602-007 |
| Olopatadine Hydrochloride | Olopatadine hydrochloride 2 mg/mL | SolutionOphthalmic | Aurohealth LLC | 58602-010 |
| Olopatadine Hydrochloride | Olopatadine hydrochloride 2 mg/mL | SolutionOphthalmic | Aurohealth LLC | 58602-013 |
| Olopatadine Hydrochloride | Olopatadine hydrochloride 2 mg/mL | SolutionOphthalmic | Best Choice | 63941-024 |
| Olopatadine Hydrochloride | Olopatadine hydrochloride 2 mg/mL | SolutionOphthalmic | BluePoint Laboratories | 68001-530 |
| Olopatadine Hydrochloride | Olopatadine hydrochloride 2 mg/mL | SolutionOphthalmic | Harris Teeter | 72036-009 |
| Olopatadine Hydrochloride | Olopatadine hydrochloride 2 mg/mL | SolutionOphthalmic | Retail Business Services, LLC. | 72476-851 |
| Olopatadine Hydrochloride | Olopatadine hydrochloride 2 mg/mL | SolutionOphthalmic | YYBA CORP | 73581-713 |
| Olopatadine Hydrochloride | Olopatadine hydrochloride 2 mg/mL | SolutionOphthalmic | Meijer | 79481-1001 |
| Olopatadine Hydrochloride | Olopatadine hydrochloride 2 mg/mL | SolutionOphthalmic | Wal-Mart Stores, Inc. | 79903-001 |
| Olopatadine Hydrochloride | Olopatadine hydrochloride 2 mg/mL | SolutionOphthalmic | Allwell Health Inc | 80539-001 |