Prescription drug · ANDA
fluorometholone NDC 0781-6187
Fluorometholone 1 mg/mL · Suspension/ drops · Ophthalmic · Sandoz Inc
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0781-6187-70 | 00781618770 | 1 BOTTLE, DROPPER in 1 CARTON (0781-6187-70) / 10 mL in 1 BOTTLE, DROPPERMarketed from May 18, 2026 | |
| 0781-6187-75 | 00781618775 | 1 BOTTLE, DROPPER in 1 CARTON (0781-6187-75) / 5 mL in 1 BOTTLE, DROPPERMarketed from May 18, 2026 |
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)
- fluorometholone
- Generic name (nonproprietary)
- fluorometholone
- Active ingredients
- Fluorometholone — 1 mg/mL
- Dosage form
- Suspension/ drops
- Route
- Ophthalmic
- Labeler
- Sandoz Inc
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 218819
- Marketing start
- Listing expires
- Other FDA classes
- Corticosteroid Hormone Receptor Agonists (Mechanism)
- Identifiers
- Product ID 0781-6187_cc330c16-7349-44a6-b1d0-b34e7f0c7594SPL ID cc330c16-7349-44a6-b1d0-b34e7f0c7594SPL set ID c9cbf06e-5413-4c3c-9ded-174c856a4ce1RxCUI 310377UNII SV0CSG527LUPC 0307816187759
- 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
N400781618770followed by a unit qualifier and the quantityPackage 00781-6187-70. 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.