Prescription drug · ANDA
fluorometholone ophthalmic suspension (Fluorometholone) NDC 60219-1585
Fluorometholone 1 mg/mL · Suspension/ drops · Ophthalmic · Amneal Pharmaceuticals LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 60219-1585-3 | 60219158503 | 1 BOTTLE, DROPPER in 1 CARTON (60219-1585-3) / 5 mL in 1 BOTTLE, DROPPERMarketed from Jan 9, 2023 |
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)
- fluorometholone ophthalmic suspension
- Generic name (nonproprietary)
- fluorometholone
- Active ingredients
- Fluorometholone — 1 mg/mL
- Dosage form
- Suspension/ drops
- Route
- Ophthalmic
- Labeler
- Amneal Pharmaceuticals LLCNDC labeler code 60219
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 216348
- Marketing start
- Listing expires
- Other FDA classes
- Corticosteroid Hormone Receptor Agonists (Mechanism)
- Identifiers
- Product ID 60219-1585_c1e7dd83-03b6-4d69-9255-720fb1df0d4fSPL ID c1e7dd83-03b6-4d69-9255-720fb1df0d4fSPL set ID e7988a3b-e432-4d42-a8d2-63ca017e6a01RxCUI 310377UNII SV0CSG527LUPC 0360219158665
- Pharmacologic class
- Corticosteroid
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
N460219158503followed by a unit qualifier and the quantityPackage 60219-1585-03. 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 Fluorometholone ophthalmic suspension is indicated for the treatment of corticosteroid-responsive inflammation of the palpebral and bulbar conjunctiva, cornea and anterior segment of the globe.
Excerpt only. Read the full label for complete information.
About NDC 60219-1585
- What is NDC 60219-1585?
- 60219-1585 is the product NDC for fluorometholone ophthalmic suspension, Fluorometholone 1 mg/mL suspension/ drops, listed with the FDA by Amneal Pharmaceuticals LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- fluorometholone ophthalmic suspension (Fluorometholone).
- What is the active ingredient?
- Fluorometholone.
- Who is the labeler?
- Amneal Pharmaceuticals LLC, NDC labeler code 60219. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for fluorometholone ophthalmic suspension?
- 1 other product NDC are listed under this name. See all fluorometholone ophthalmic suspension NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other fluorometholone ophthalmic suspension products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| fluorometholone ophthalmic suspensionfluorometholone | Fluorometholone 1 mg/mL | Suspension/ dropsOphthalmic | Amneal Pharmaceuticals LLC | 60219-1586 | 60219-1586-06 |
Other NDCs under ANDA 216348
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 |
|---|---|---|---|---|
| fluorometholone ophthalmic suspensionfluorometholone | Fluorometholone 1 mg/mL | Suspension/ dropsOphthalmic | Amneal Pharmaceuticals LLC | 60219-1586 |