Over-the-counter drug · NDA
Eye Itch Relief (Ketotifen fumarate) NDC 0363-0038
Ketotifen fumarate .35 mg/mL · Solution · Ophthalmic · Walgreen Company
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0363-0038-05 | 0036300380500363003805 | 1 BOTTLE in 1 CARTON (0363-0038-05) / 5 mL in 1 BOTTLEMarketed from Sep 3, 2013 | |
| 0363-0038-10 | 0036300381000363003810 | 1 BOTTLE in 1 CARTON (0363-0038-10) / 10 mL in 1 BOTTLEMarketed from Sep 3, 2013 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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 — .35 mg/mL
- Dosage form
- Solution
- Route
- Ophthalmic
- Labeler
- Walgreen CompanyNDC labeler code 0363
- 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 0363-0038_4ddfb3f8-812d-c7c4-e063-6394a90a284dSPL ID 4ddfb3f8-812d-c7c4-e063-6394a90a284dSPL set ID 9ce8f926-c202-40d1-9dba-0477f1f49e14RxCUI 311237UNII HBD503WORO
- 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
N400363003805followed by a unit qualifier and the quantityPackage 00363-0038-05. 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.
About NDC 0363-0038
- What is NDC 0363-0038?
- 0363-0038 is the product NDC for Eye Itch Relief (ketotifen fumarate), Ketotifen fumarate .35 mg/mL solution, listed with the FDA by Walgreen Company. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Eye Itch Relief (Ketotifen fumarate).
- What is the active ingredient?
- Ketotifen fumarate.
- Who is the labeler?
- Walgreen Company, NDC labeler code 0363. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Eye Itch Relief?
- 10 other product NDCs are listed under this name. See all Eye Itch Relief NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Eye Itch Relief products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Eye Itch Reliefketotifen fumarate | Ketotifen fumarate .25 mg/mL | Solution/ dropsOphthalmic | A-S Medication Solutions | 50090-7253 | 50090-7253-00 |
| Eye Itch Reliefketotifen fumarate | Ketotifen fumarate .25 mg/mL | Solution/ dropsOphthalmic | PERRIGO DIRECT INC. | 50804-601 | 50804-0601-05 |
| Eye Itch Reliefketotifen fumarate | Ketotifen fumarate .25 mg/mL | Solution/ dropsOphthalmic | Kroger Company | 30142-398 | 30142-0398-05 |
| Eye Itch Reliefketotifen fumarate | Ketotifen fumarate .25 mg/mL | Solution/ dropsOphthalmic | TOPCO ASSOCIATES LLC | 36800-097 | 36800-0097-05 |
| Eye Itch Reliefketotifen fumarate | Ketotifen fumarate .25 mg/mL | SolutionOphthalmic | Redpharm Drug | 67296-2245 | 67296-2245-05 |
| Eye Itch Reliefketotifen fumarate | Ketotifen fumarate .25 mg/mL | SolutionOphthalmic | Cardinal Health | 70000-0522 | 70000-0522-0170000-0522-02 |
| Eye Itch Reliefketotifen fumarate | Ketotifen fumarate .25 mg/mL | Solution/ dropsOphthalmic | CVS Pharmacy | 69842-275 | 69842-0275-0569842-0275-1069842-0275-20 |
| Eye Itch Reliefketotifen fumarate | Ketotifen fumarate .35 mg/mL | Solution/ dropsOphthalmic | CARDINAL HEALTH 110, LLC. DBA LEADER | 70000-0124 | 70000-0124-01 |
| Eye Itch Reliefketotifen fumarate | Ketotifen fumarate .25 mg/mL | SolutionOphthalmic | Safeway | 21130-601 | 21130-0601-05 |
| Eye Itch Reliefketotifen fumarate | Ketotifen fumarate .25 mg/mL | SolutionOphthalmic | Target Corporation | 11673-064 | 11673-0064-05 |
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 |
|---|---|---|---|---|
| Alawayketotifen fumarate | Ketotifen fumarate .25 mg/mL | Solution/ dropsOphthalmic | Bausch & Lomb Incorporated | 24208-601 |
| 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 | Target Corporation | 11673-064 |
| Eye Itch Reliefketotifen fumarate | Ketotifen fumarate .25 mg/mL | SolutionOphthalmic | Safeway | 21130-601 |
| 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 | TOPCO ASSOCIATES LLC | 36800-097 |
| Eye Itch Reliefketotifen fumarate | Ketotifen fumarate .25 mg/mL | Solution/ dropsOphthalmic | A-S Medication Solutions | 50090-7253 |
| 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 | SolutionOphthalmic | Redpharm Drug | 67296-2245 |
| 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 | Cardinal Health | 70000-0522 |
| Ketotifen Fumarate | Ketotifen fumarate .25 mg/mL | Solution/ dropsOphthalmic | Rugby Laboratories | 0536-1252 |
| Ketotifen Fumarate | Ketotifen fumarate .25 mg/mL | Solution/ dropsOphthalmic | A-S Medication Solutions | 50090-6472 |