Prescription drug · ANDA
Loteprednol etabonate and Tobramycin NDC 46708-801
Loteprednol etabonate 5 mg/mL; Tobramycin 3 mg/mL · Suspension/ drops · Ophthalmic · Alembic Pharmaceuticals Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 46708-801-05 | 46708080105 | 1 BOTTLE in 1 CARTON (46708-801-05) / 5 mL in 1 BOTTLEMarketed from Dec 10, 2025 | |
| 46708-801-10 | 46708080110 | 1 BOTTLE in 1 CARTON (46708-801-10) / 10 mL in 1 BOTTLEMarketed from Dec 10, 2025 |
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
- Suspension/ drops
- Route
- Ophthalmic
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 217597
- Marketing start
- Listing expires
- Other FDA classes
- Aminoglycosides (Chemical structure)Corticosteroid Hormone Receptor Agonists (Mechanism)
- Identifiers
- Product ID 46708-801_a6d68829-f7b6-4b9b-ad44-110c47609918SPL ID a6d68829-f7b6-4b9b-ad44-110c47609918SPL set ID a6d68829-f7b6-4b9b-ad44-110c47609918RxCUI 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
N446708080105followed by a unit qualifier and the quantityPackage 46708-0801-05. 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…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 217597
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 and Tobramycin | Loteprednol etabonate 5 mg/mL; Tobramycin 3 mg/mL | Suspension/ dropsOphthalmic | Alembic Pharmaceuticals Inc. | 62332-801 |