Prescription drug · NDA
Natacyn (natamycin) NDC 82667-012
Natamycin 50 mg/mL · Suspension/ drops · Ophthalmic · Harrow Eye, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 82667-012-05 | 82667001205 | 1 BOTTLE, GLASS in 1 CARTON (82667-012-05) / 15 mL in 1 BOTTLE, GLASSMarketed from Nov 1, 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)
- Natacyn
- Generic name (nonproprietary)
- natamycin
- Active ingredients
- Natamycin — 50 mg/mL
- Dosage form
- Suspension/ drops
- Route
- Ophthalmic
- Labeler
- Harrow Eye, LLC
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 050514
- Marketing start
- Listing expires
- Other FDA classes
- Polyenes (Chemical structure)
- Identifiers
- Product ID 82667-012_42678f74-383b-962f-e063-6394a90a3315SPL ID 42678f74-383b-962f-e063-6394a90a3315SPL set ID 20ede08c-0d39-dc65-e063-6394a90aa3e0RxCUI 204451, 207100UNII 8O0C852CPO
- Pharmacologic class
- Polyene Antimicrobial
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
N482667001205followed by a unit qualifier and the quantityPackage 82667-0012-05. 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)
INDICATIONS AND USAGE: NATACYN™ (natamycin ophthalmic suspension) 5% is indicated for the treatment of fungal blepharitis, conjunctivitis, and keratitis caused by susceptible organisms including Fusarium solani keratitis. As in other forms of suppurative keratitis, initial and sustained therapy of fungal keratitis should be determined by the clinical diagnosis, laboratory diagnosis by smear and culture of corneal scrapings and drug response. Whenever possible the in vitro activity of natamycin against the responsible fungus should be determined. The effectiveness of natamycin as a single agent in fungal endophthalmitis has not been established.
Excerpt only. Read the full label for complete information.
Other NDCs under NDA 050514
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 |
|---|---|---|---|---|
| Natacynnatamycin | Natamycin 50 mg/mL | Suspension/ dropsOphthalmic | Eyevance Pharmaceuticals, LLC | 71776-005 |