Zylet NDC 24208-358

NDC codes

FDA NDC Directory

Product NDC (as listed)24208-358Labeler and product segments. Claims need a package NDC.

Product NDC at billing width24208-0358Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package
24208-358-01	24208035801	1 BOTTLE, DROPPER in 1 CARTON (24208-358-01) / 1 mL in 1 BOTTLE, DROPPERMarketed from Dec 14, 2004 · Sample package
24208-358-05	24208035805	1 BOTTLE, DROPPER in 1 CARTON (24208-358-05) / 5 mL in 1 BOTTLE, DROPPERMarketed from Dec 14, 2004
24208-358-10	24208035810	1 BOTTLE, DROPPER in 1 CARTON (24208-358-10) / 10 mL in 1 BOTTLE, DROPPERMarketed from Dec 14, 2004

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): Zylet
Generic name (nonproprietary): loteprednol etabonate and tobramycin
Active ingredients: Loteprednol etabonate — 5 mg/mLTobramycin — 3 mg/mL
Dosage form: Suspension/ drops
Route: Ophthalmic
Labeler: Bausch & Lomb Incorporated
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 050804
Marketing start: Dec 14, 2004
Listing expires: Dec 31, 2026
Other FDA classes: Aminoglycosides (Chemical structure)Corticosteroid Hormone Receptor Agonists (Mechanism)
Identifiers: Product ID 24208-358_4e532599-a607-4047-a600-d3e32fd515a4SPL ID 4e532599-a607-4047-a600-d3e32fd515a4SPL set ID 3dd9b060-5355-404d-bdf1-09ee8b52a9f5RxCUI 545255, 545259UNII 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

N424208035801 followed by a unit qualifier and the quantity

Package 24208-0358-01. 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 Apr 30, 2022.

Indications (excerpt from the label)

ZYLET ® (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 dimi…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under NDA 050804

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under NDA 050804
Product	Strength	Form · route	Labeler	Product NDC
Loteprednol etabonate and tobramycin	Loteprednol etabonate 5 mg/mL; Tobramycin 3 mg/mL	Solution/ dropsOphthalmic	Bausch & Lomb Americas Inc.	82260-358