Over-the-counter drug · ANDA
Olopatadine Hydrochloride (olopatadine hydrochloride ophthalmic) NDC 72657-168
Olopatadine hydrochloride 1 mg/mL · Solution · Ophthalmic · GLENMARK THERAPEUTICS INC., USA
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72657-168-50 | 72657016850 | 1 BOTTLE, PLASTIC in 1 CARTON (72657-168-50) / 5 mL in 1 BOTTLE, PLASTICMarketed from Jul 26, 2024 |
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 ophthalmic
- Active ingredients
- Olopatadine hydrochloride — 1 mg/mL
- Dosage form
- Solution
- Route
- Ophthalmic
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 200810
- Marketing start
- Listing expires
- Other FDA classes
- Decreased Histamine Release (Physiologic effect)Histamine H1 Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 72657-168_bc82a9d3-2fd3-4a7d-9126-c0f07a610b05SPL ID bc82a9d3-2fd3-4a7d-9126-c0f07a610b05SPL set ID a80c3fd2-47b7-4ed0-b862-9c5099684607RxCUI 1111339UNII 2XG66W44KFUPC 0372657168502
- 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
N472657016850followed by a unit qualifier and the quantityPackage 72657-0168-50. 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)
Uses temporarily relieves itchy and red eyes due to pollen, ragweed, grass, animal hair and dander
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 200810
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 Hydrochlorideolopatadine hydrochloride ophthalmic | Olopatadine hydrochloride 1 mg/mL | SolutionOphthalmic | Strategic Sourcing Services LLC | 70677-1280 |
| Olopatadine Hydrochlorideolopatadine hydrochloride ophthalmic | Olopatadine hydrochloride 1 mg/mL | SolutionOphthalmic | AmerisourceBergen Drug Corp | 46122-823 |
| Olopatadine Hydrochlorideolopatadine hydrochloride ophthalmic | Olopatadine hydrochloride 1 mg/mL | SolutionOphthalmic | Golden State Medical Supply, Inc. | 51407-938 |