Over-the-counter drug · ANDA
Ketotifen Fumarate Ophthalmic Solution (Ketotifen fumarate) NDC 72485-617
Ketotifen fumarate .25 mg/mL · Solution/ drops · Ophthalmic · Armas Pharmaceuticals Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72485-617-10 | 7248506171072485061710 | 1 BOTTLE, DROPPER in 1 CARTON (72485-617-10) / 5 mL in 1 BOTTLE, DROPPERMarketed from Oct 9, 2023 |
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)
- Ketotifen Fumarate Ophthalmic Solution
- Generic name (nonproprietary)
- ketotifen fumarate
- Active ingredients
- Ketotifen fumarate — .25 mg/mL
- Dosage form
- Solution/ drops
- Route
- Ophthalmic
- Labeler
- Armas Pharmaceuticals Inc.NDC labeler code 72485
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 077958
- Marketing start
- Listing expires
- Other FDA classes
- Histamine H1 Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 72485-617_cd02d900-5bfc-494b-a588-8f6098fe058eSPL ID cd02d900-5bfc-494b-a588-8f6098fe058eSPL set ID b1ea15a5-5354-4086-a22d-cc1b3e0e1eb3RxCUI 311237UNII HBD503WOROUPC 0372485617104
- 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
N472485061710followed by a unit qualifier and the quantityPackage 72485-0617-10. 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.
About NDC 72485-617
- What is NDC 72485-617?
- 72485-617 is the product NDC for Ketotifen Fumarate Ophthalmic Solution, Ketotifen fumarate .25 mg/mL solution/ drops, listed with the FDA by Armas Pharmaceuticals Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Ketotifen Fumarate Ophthalmic Solution (Ketotifen Fumarate).
- What is the active ingredient?
- Ketotifen fumarate.
- Who is the labeler?
- Armas Pharmaceuticals Inc., NDC labeler code 72485. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Ketotifen Fumarate Ophthalmic Solution?
- 2 other product NDCs are listed under this name. See all Ketotifen Fumarate Ophthalmic Solution NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Ketotifen Fumarate Ophthalmic Solution products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Ketotifen Fumarate Ophthalmic Solutionketotifen fumarate | Ketotifen fumarate .25 mg/mL | Solution/ dropsOphthalmic | Sentiss Pharmaceuticals LLC | 70244-041 | 70244-0041-01 |
| Ketotifen Fumarate Ophthalmic Solutionketotifen fumarate | Ketotifen fumarate .25 mg/mL | Solution/ dropsOphthalmic | Preferred Pharmaceuticals Inc. | 68788-4084 | 68788-4084-05 |
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 |
|---|---|---|---|---|
| Eye Itch Reliefketotifen fumarate | Ketotifen fumarate .35 mg/mL | Solution/ dropsOphthalmic | CARDINAL HEALTH 110, LLC. DBA LEADER | 70000-0124 |
| 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 |