Over-the-counter drug · ANDA
Olopatadine Hydrochloride Ophthalmic Solution NDC 68083-231
olopatadine hydrochloride ophthalmic · Olopatadine hydrochloride 2 mg/mL · Solution · Ophthalmic · Gland Pharma Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68083-231-01 | 68083023101 | 1 BOTTLE, PLASTIC in 1 CARTON (68083-231-01) / 2.5 mL in 1 BOTTLE, PLASTICMarketed from May 20, 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 Ophthalmic Solution
- Generic name (nonproprietary)
- olopatadine hydrochloride ophthalmic
- Active ingredients
- Olopatadine hydrochloride — 2 mg/mL
- Dosage form
- Solution
- Route
- Ophthalmic
- Labeler
- Gland Pharma Limited
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 209752
- Marketing start
- Listing expires
- Other FDA classes
- Decreased Histamine Release (Physiologic effect)Histamine H1 Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 68083-231_4657bfb5-f22c-4739-9455-f3ca695d0e5dSPL ID 4657bfb5-f22c-4739-9455-f3ca695d0e5dSPL set ID 9a4c58dc-aee6-441f-8081-608e4fd36193RxCUI 1111343UNII 2XG66W44KFUPC 0368083231019
- 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
N468083023101followed by a unit qualifier and the quantityPackage 68083-0231-01. 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
Label details couldn’t be retrieved right now. Open the label on DailyMed.