Over-the-counter drug · ANDA
Olopatadine Hydrochloride NDC 70069-491
Olopatadine hydrochloride 2 mg/mL · Solution/ drops · Ophthalmic · Somerset Therapeutics, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70069-491-01 | 70069049101 | 1 BOTTLE, PLASTIC in 1 CARTON (70069-491-01) / 2.5 mL in 1 BOTTLE, PLASTICMarketed from Dec 20, 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
- Active ingredients
- Olopatadine hydrochloride — 2 mg/mL
- Dosage form
- Solution/ drops
- Route
- Ophthalmic
- Labeler
- Somerset Therapeutics, LLC
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 215006
- Marketing start
- Listing expires
- Other FDA classes
- Decreased Histamine Release (Physiologic effect)Histamine H1 Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 70069-491_78c4829c-7c27-4a0a-a92f-c0596f773a74SPL ID 78c4829c-7c27-4a0a-a92f-c0596f773a74SPL set ID 6ee9f8f5-973c-4c71-8069-e76cd87b07dcRxCUI 1111343UNII 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
N470069049101followed by a unit qualifier and the quantityPackage 70069-0491-01. 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
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.