Lotemax (loteprednol etabonate) NDC 24208-503

NDC codes

FDA NDC Directory

Product NDC (as listed)24208-503Labeler and product segments. Claims need a package NDC.

Product NDC at billing width24208-0503Add 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
24208-503-07	24208050307	1 BOTTLE in 1 CARTON (24208-503-07) / 5 g in 1 BOTTLEMarketed from Oct 12, 2012
24208-503-48	24208050348	1 BOTTLE in 1 CARTON (24208-503-48) / .5 g in 1 BOTTLEMarketed from Oct 12, 2012 · Sample package
24208-503-96	24208050396	1 BOTTLE in 1 CARTON (24208-503-96) / 5 g in 1 BOTTLEMarketed from Oct 12, 2012 · Sample package

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): Lotemax
Generic name (nonproprietary): loteprednol etabonate
Active ingredients: Loteprednol etabonate — 5 mg/g
Dosage form: Gel
Route: Ophthalmic
Labeler: Bausch & Lomb Incorporated
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 202872
Marketing start: Oct 12, 2012
Listing expires: Dec 31, 2026
Other FDA classes: Corticosteroid Hormone Receptor Agonists (Mechanism)
Identifiers: Product ID 24208-503_253b0a9d-16fe-2eb1-e063-6294a90ac5e0SPL ID 253b0a9d-16fe-2eb1-e063-6294a90ac5e0SPL set ID 9a666065-d467-42b8-8ecd-0ec1de9986d5RxCUI 1312625, 1312627UNII YEH1EZ96K6
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

N424208050307 followed by a unit qualifier and the quantity

Package 24208-0503-07. 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 Oct 24, 2024.

Indications (excerpt from the label)

LOTEMAX ® (loteprednol etabonate ophthalmic gel) 0.5% is a corticosteroid indicated for the treatment of post-operative inflammation and pain following ocular surgery. LOTEMAX is a corticosteroid indicated for the treatment of postoperative inflammation and pain following ocular surgery. ( 1 )

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under NDA 202872

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

FDA NDC Directory listings under NDA 202872
Product	Strength	Form · route	Labeler	Product NDC
Loteprednol Etabonate	Loteprednol etabonate 5 mg/g	GelOphthalmic	Bausch & Lomb Americas Inc.	82260-508
Loteprednol Etabonate	Loteprednol etabonate 5 mg/g	GelOphthalmic	Bausch & Lomb Incorporated	24208-508