Over-the-counter drug · NDA
Eye Itch Relief (ketotifen fumarate) NDC 36800-097
Ketotifen fumarate .25 mg/mL · Solution/ drops · Ophthalmic · TOPCO ASSOCIATES LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 36800-097-05 | 36800009705 | 1 BOTTLE, DROPPER in 1 CARTON (36800-097-05) / 5 mL in 1 BOTTLE, DROPPERMarketed from Mar 15, 2022 |
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)
- Eye Itch Relief
- Generic name (nonproprietary)
- ketotifen fumarate
- Active ingredients
- Ketotifen fumarate — .25 mg/mL
- Dosage form
- Solution/ drops
- Route
- Ophthalmic
- Labeler
- TOPCO ASSOCIATES LLC
- Product type
- Over-the-counter drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 021996
- Marketing start
- Listing expires
- Other FDA classes
- Histamine H1 Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 36800-097_6ca0ed6a-4b37-44b1-97d1-7855ab238077SPL ID 6ca0ed6a-4b37-44b1-97d1-7855ab238077SPL set ID b723daa3-6c6f-4a96-a15d-0d5866f28ca4RxCUI 311237UNII HBD503WOROUPC 0036800489714
- Pharmacologic class
- Histamine-1 Receptor Inhibitor
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
N436800009705followed by a unit qualifier and the quantityPackage 36800-0097-05. 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 for the temporary relief of itchy eyes due to ragweed, pollen, grass, animal hair and dander.
Excerpt only. Read the full label for complete information.
Other NDCs under NDA 021996
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 |
|---|---|---|---|---|
| Eye Itch Reliefketotifen fumarate | Ketotifen fumarate .25 mg/mL | Solution/ dropsOphthalmic | PERRIGO DIRECT INC. | 50804-601 |
| Eye Itch Reliefketotifen fumarate | Ketotifen fumarate .25 mg/mL | Solution/ dropsOphthalmic | CVS Pharmacy | 69842-275 |
| Eye Itch Reliefketotifen fumarate | Ketotifen fumarate .25 mg/mL | SolutionOphthalmic | Target Corporation | 11673-064 |
| Eye Itch Reliefketotifen fumarate | Ketotifen fumarate .25 mg/mL | SolutionOphthalmic | Cardinal Health | 70000-0522 |
| Ketotifen Fumarate | Ketotifen fumarate .25 mg/mL | Solution/ dropsOphthalmic | Rugby Laboratories | 0536-1252 |
| Eye Itch Reliefketotifen fumarate | Ketotifen fumarate .25 mg/mL | SolutionOphthalmic | Safeway | 21130-601 |
| Alawayketotifen fumarate | Ketotifen fumarate .25 mg/mL | Solution/ dropsOphthalmic | Bausch & Lomb Incorporated | 24208-601 |
| Ketotifen Fumarate | Ketotifen fumarate .25 mg/mL | Solution/ dropsOphthalmic | A-S Medication Solutions | 50090-6472 |
| Eye Itch Releifketotifen fumarate | Ketotifen fumarate .25 mg/mL | Solution/ dropsOphthalmic | Rite Aid Corporation | 11822-5533 |
| Eye Itch Reliefketotifen fumarate | Ketotifen fumarate .35 mg/mL | SolutionOphthalmic | Walgreen Company | 0363-0038 |
| Equate Eye Itch Reliefketotifen fumarate | Ketotifen fumarate .25 mg/mL | SolutionOphthalmic | Wal-Mart Stores, Inc. | 49035-231 |
| Eye Itch Reliefketotifen fumarate | Ketotifen fumarate .25 mg/mL | SolutionOphthalmic | Redpharm Drug | 67296-2245 |
| Eye Itch Reliefketotifen fumarate | Ketotifen fumarate .25 mg/mL | Solution/ dropsOphthalmic | Kroger Company | 30142-398 |
| Eye Itch Reliefketotifen fumarate | Ketotifen fumarate .25 mg/mL | Solution/ dropsOphthalmic | A-S Medication Solutions | 50090-7253 |