Prescription drug · ANDA
Loteprednol Etabonate NDC 62756-232
Loteprednol etabonate 5 mg/mL · Suspension/ drops · Ophthalmic · Sun Pharmaceutical Industries, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 62756-232-55 | 62756023255 | 1 BOTTLE in 1 CARTON (62756-232-55) / 10 mL in 1 BOTTLEMarketed from May 1, 2021 | |
| 62756-232-56 | 62756023256 | 1 BOTTLE in 1 CARTON (62756-232-56) / 15 mL in 1 BOTTLEMarketed from May 1, 2021 | |
| 62756-232-90 | 62756023290 | 1 BOTTLE in 1 CARTON (62756-232-90) / 5 mL in 1 BOTTLEMarketed from May 1, 2021 |
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 — 5 mg/mL
- Dosage form
- Suspension/ drops
- Route
- Ophthalmic
- Labeler
- Sun Pharmaceutical Industries, Inc.NDC labeler code 62756
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 212450
- Marketing start
- Marketing end
- Other FDA classes
- Corticosteroid Hormone Receptor Agonists (Mechanism)
- Identifiers
- Product ID 62756-232_567c4575-7310-9f12-e063-6294a90afee6SPL ID 567c4575-7310-9f12-e063-6294a90afee6SPL set ID 36cfd5b8-c892-44e1-aaed-fb32d7aeca7cRxCUI 311382UNII YEH1EZ96K6UPC 0362756232907
- 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
N462756023255followed by a unit qualifier and the quantityPackage 62756-0232-55. 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 treatment of steroid responsive inflammatory conditions of the palpebral and bulbar conjunctiva, cornea and anterior segment of the globe such as allergic conjunctivitis, acne rosacea, superficial punctate keratitis, herpes zoster keratitis, iritis, cyclitis, selected infective conjunctivitides, when the inherent hazard of steroid use is accepted to obtain an advisable diminution in edema and inflammation. Loteprednol etabonate ophthalmic suspension is less effective than prednisolone acetate 1% in two 28-day controlled clinical studies in acute anterior uveitis, where 72% of patients treated with lotepre…
Excerpt only. Read the full label for complete information.
About NDC 62756-232
- What is NDC 62756-232?
- 62756-232 is the product NDC for Loteprednol Etabonate, Loteprednol etabonate 5 mg/mL suspension/ drops, listed with the FDA by Sun Pharmaceutical Industries, Inc.. It has 3 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?
- Sun Pharmaceutical Industries, Inc., NDC labeler code 62756. 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 212450
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 5 mg/mL | Suspension/ dropsOphthalmic | NorthStar RxLLC | 72603-324 |