Prescription drug · ANDA
Loteprednol Etabonate NDC 72485-653
Loteprednol etabonate 2 mg/mL · Suspension/ drops · Ophthalmic · ARMAS PHARMACEUTICALS INC.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72485-653-05 | 7248506530572485065305 | 1 BOTTLE, DROPPER in 1 CARTON (72485-653-05) / 5 mL in 1 BOTTLE, DROPPERMarketed from Oct 24, 2023 | |
| 72485-653-10 | 7248506531072485065310 | 1 BOTTLE, DROPPER in 1 CARTON (72485-653-10) / 10 mL in 1 BOTTLE, DROPPERMarketed from Oct 24, 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)
- Loteprednol Etabonate
- Generic name (nonproprietary)
- loteprednol etabonate
- Active ingredients
- Loteprednol etabonate — 2 mg/mL
- Dosage form
- Suspension/ drops
- Route
- Ophthalmic
- Labeler
- ARMAS PHARMACEUTICALS INC.NDC labeler code 72485
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 215933
- Marketing start
- Listing expires
- Other FDA classes
- Corticosteroid Hormone Receptor Agonists (Mechanism)
- Identifiers
- Product ID 72485-653_1a784c5a-bdb4-c5b8-e063-6394a90a8f9cSPL ID 1a784c5a-bdb4-c5b8-e063-6394a90a8f9cSPL set ID 36c05fa4-6562-4af8-86ac-e79003ee65ddRxCUI 311381UNII YEH1EZ96K6UPC 0372485653058, 0372485653102
- 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
N472485065305followed by a unit qualifier and the quantityPackage 72485-0653-05. 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 Loteprednol etabonate ophthalmic suspension is indicated for the temporary relief of the signs and symptoms of seasonal allergic conjunctivitis.
Excerpt only. Read the full label for complete information.
About NDC 72485-653
- What is NDC 72485-653?
- 72485-653 is the product NDC for Loteprednol Etabonate, Loteprednol etabonate 2 mg/mL suspension/ drops, listed with the FDA by ARMAS PHARMACEUTICALS INC.. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Loteprednol Etabonate.
- What is the active ingredient?
- Loteprednol etabonate.
- 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 Loteprednol Etabonate?
- 18 other product NDCs are listed under this name. See all Loteprednol Etabonate NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Loteprednol Etabonate products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Loteprednol Etabonate | Loteprednol etabonate 5 mg/mL | Suspension/ dropsOphthalmic | Sentiss Pharmaceuticals LLC | 70244-034 | 70244-0034-0170244-0034-0270244-0034-03 |
| Loteprednol Etabonate | Loteprednol etabonate 2 mg/mL | Suspension/ dropsOphthalmic | Sentiss Pharmaceuticals LLC | 70244-035 | 70244-0035-0170244-0035-02 |
| Loteprednol Etabonate | Loteprednol etabonate 5 mg/g | GelOphthalmic | Sentiss Pharmaceuticals LLC | 70244-036 | 70244-0036-01 |
| Loteprednol Etabonate | Loteprednol etabonate 2 mg/mL | Suspension/ dropsOphthalmic | Padagis US LLC | 0574-4080 | 00574-4080-0500574-4080-10 |
| Loteprednol Etabonate | Loteprednol etabonate 5 mg/mL | Suspension/ dropsOphthalmic | Padagis US LLC | 0574-4135 | 00574-4135-0500574-4135-1000574-4135-15 |
| loteprednol etabonate | Loteprednol etabonate 5 mg/mL | SuspensionOphthalmic | Lupin Pharmaceuticals, Inc. | 70748-300 | 70748-0300-0170748-0300-02 |
| Loteprednol Etabonate | Loteprednol etabonate 5 mg/mL | Suspension/ dropsOphthalmic | Amneal Pharmaceuticals NY LLC | 60219-1362 | 60219-1362-0160219-1362-0260219-1362-03 |
| loteprednol etabonate | Loteprednol etabonate 2 mg/mL | Suspension/ dropsOphthalmic | Amneal Pharmaceuticals NY LLC | 60219-1366 | 60219-1366-03 |
| loteprednol etabonate | Loteprednol etabonate 2 mg/mL | Suspension/ dropsOphthalmic | Amneal Pharmaceuticals NY LLC | 60219-1367 | 60219-1367-06 |
| Loteprednol Etabonate | Loteprednol etabonate 5 mg/mL | Suspension/ dropsOphthalmic | NorthStar RxLLC | 72603-324 | 72603-0324-01 |
Other NDCs under ANDA 215933
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 |
|---|---|---|---|---|
| Loteprednol Etabonate | Loteprednol etabonate 2 mg/mL | Suspension/ dropsOphthalmic | Sentiss Pharmaceuticals LLC | 70244-035 |
| Loteprednol Etabonate | Loteprednol etabonate 2 mg/mL | Suspension/ dropsOphthalmic | Sportpharm LLC | 85766-193 |