Prescription drug · NDA AUTHORIZED GENERIC
Loteprednol etabonate and tobramycin NDC 82260-358
Loteprednol etabonate 5 mg/mL; Tobramycin 3 mg/mL · Solution/ drops · Ophthalmic · Bausch & Lomb Americas Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 82260-358-05 | 8226003580582260035805 | 1 BOTTLE, DROPPER in 1 CARTON (82260-358-05) / 5 mL in 1 BOTTLE, DROPPERMarketed from Jan 9, 2026 | |
| 82260-358-10 | 8226003581082260035810 | 1 BOTTLE, DROPPER in 1 CARTON (82260-358-10) / 10 mL in 1 BOTTLE, DROPPERMarketed from Jan 9, 2026 |
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 and tobramycin
- Generic name (nonproprietary)
- loteprednol etabonate and tobramycin
- Active ingredients
- Loteprednol etabonate — 5 mg/mLTobramycin — 3 mg/mL
- Dosage form
- Solution/ drops
- Route
- Ophthalmic
- Labeler
- Bausch & Lomb Americas Inc.NDC labeler code 82260
- Product type
- Prescription drug
- Marketing category
- NDA authorized genericApplication NDA 050804
- Marketing start
- Listing expires
- Other FDA classes
- Aminoglycosides (Chemical structure)Corticosteroid Hormone Receptor Agonists (Mechanism)
- Identifiers
- Product ID 82260-358_48d4400d-e246-f109-e063-6394a90a8103SPL ID 48d4400d-e246-f109-e063-6394a90a8103SPL set ID 75df79e9-f064-4f46-9837-8d4d536517a3RxCUI 545255UNII YEH1EZ96K6, VZ8RRZ51VK
- Pharmacologic class
- Aminoglycoside Antibacterial; 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
N482260035805followed by a unit qualifier and the quantityPackage 82260-0358-05. 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)
Loteprednol Etabonate and Tobramycin Ophthalmic Suspension 0.5%/0.3% is a topical anti-infective and corticosteroid combination for steroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and where superficial bacterial ocular infection or a risk of bacterial ocular infection exists. Ocular steroids are indicated in 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, and where the inherent risk of steroid use in certain infective conjunctivitides is accepted to obtain a diminution in e…
Excerpt only. Read the full label for complete information.
About NDC 82260-358
- What is NDC 82260-358?
- 82260-358 is the product NDC for Loteprednol etabonate and tobramycin, Loteprednol etabonate 5 mg/mL; Tobramycin 3 mg/mL solution/ drops, listed with the FDA by Bausch & Lomb Americas Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Loteprednol etabonate and tobramycin.
- What is the active ingredient?
- Loteprednol etabonate, Tobramycin.
- Who is the labeler?
- Bausch & Lomb Americas Inc., NDC labeler code 82260. 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 and tobramycin?
- 2 other product NDCs are listed under this name. See all Loteprednol etabonate and tobramycin 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 and tobramycin 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 and Tobramycin | Loteprednol etabonate 5 mg/mL; Tobramycin 3 mg/mL | Suspension/ dropsOphthalmic | Alembic Pharmaceuticals Limited | 46708-801 | 46708-0801-0546708-0801-10 |
| Loteprednol etabonate and Tobramycin | Loteprednol etabonate 5 mg/mL; Tobramycin 3 mg/mL | Suspension/ dropsOphthalmic | Alembic Pharmaceuticals Inc. | 62332-801 | 62332-0801-0562332-0801-10 |
Other NDCs under NDA 050804
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 |
|---|---|---|---|---|
| Zyletloteprednol etabonate and tobramycin | Loteprednol etabonate 5 mg/mL; Tobramycin 3 mg/mL | Suspension/ dropsOphthalmic | Bausch & Lomb Incorporated | 24208-358 |