Over-the-counter drug · ANDA
Eye Itch Relief (Ketotifen fumarate) NDC 70000-0124
Ketotifen fumarate .35 mg/mL · Solution/ drops · Ophthalmic · CARDINAL HEALTH 110, LLC. DBA LEADER
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70000-0124-1 | 7000001240170000012401 | 1 BOTTLE, DROPPER in 1 CARTON (70000-0124-1) / 5 mL in 1 BOTTLE, DROPPERMarketed from Jan 18, 2017 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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/ drops
- Route
- Ophthalmic
- Labeler
- CARDINAL HEALTH 110, LLC. DBA LEADERNDC labeler code 70000
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 077958
- Marketing start
- Marketing end
- Other FDA classes
- Histamine H1 Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 70000-0124_0c2e7ac9-3977-48ba-995c-004dba0d0ad5SPL ID 0c2e7ac9-3977-48ba-995c-004dba0d0ad5SPL set ID add414c5-b6c5-4bb5-8d8a-ddc507a27131RxCUI 311237UNII HBD503WOROUPC 0096295128901
- 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
N470000012401followed by a unit qualifier and the quantityPackage 70000-0124-01. 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)
Uses Temporarily relieves itchy eyes due to pollen, ragweed, grass, animal hair and dander.
Excerpt only. Read the full label for complete information.
About NDC 70000-0124
- What is NDC 70000-0124?
- 70000-0124 is the product NDC for Eye Itch Relief (ketotifen fumarate), Ketotifen fumarate .35 mg/mL solution/ drops, listed with the FDA by CARDINAL HEALTH 110, LLC. DBA LEADER. It has 1 package NDC, 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?
- CARDINAL HEALTH 110, LLC. DBA LEADER, NDC labeler code 70000. 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 .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 |
| Eye Itch Reliefketotifen fumarate | Ketotifen fumarate .35 mg/mL | SolutionOphthalmic | Walgreen Company | 0363-0038 | 00363-0038-0500363-0038-10 |
Other NDCs under ANDA 077958
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 |
|---|---|---|---|---|
| Ketotifen Fumarate | Ketotifen fumarate .35 mg/mL | Solution/ dropsOphthalmic | Proficient Rx LP | 71205-115 |
| Ketotifen Fumarate Ophthalmic Solutionketotifen fumarate | Ketotifen fumarate .25 mg/mL | Solution/ dropsOphthalmic | Preferred Pharmaceuticals Inc. | 68788-4084 |
| Ketotifen Fumarate Ophthalmic Solutionketotifen fumarate | Ketotifen fumarate .25 mg/mL | Solution/ dropsOphthalmic | Sentiss Pharmaceuticals LLC | 70244-041 |
| Ketotifen Fumarate Ophthalmic Solutionketotifen fumarate | Ketotifen fumarate .25 mg/mL | Solution/ dropsOphthalmic | Armas Pharmaceuticals Inc. | 72485-617 |