NDC codes

FDA NDC Directory
Product NDC (as listed)24208-299Labeler and product segments. Claims need a package NDC.
Product NDC at billing width24208-0299Add 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 NDC11-digit (billing)PackageCopy
24208-299-01242080299011 BOTTLE in 1 CARTON (24208-299-01) / 1 mL in 1 BOTTLEMarketed from Dec 15, 2020 · Sample package
24208-299-05242080299051 BOTTLE in 1 CARTON (24208-299-05) / 5 mL in 1 BOTTLEMarketed from Sep 3, 1998
24208-299-10242080299101 BOTTLE in 1 CARTON (24208-299-10) / 10 mL in 1 BOTTLEMarketed from Sep 3, 1998
24208-299-15242080299151 BOTTLE in 1 CARTON (24208-299-15) / 15 mL in 1 BOTTLEMarketed from Sep 3, 1998

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/mL
Dosage form
Suspension/ drops
Route
Ophthalmic
Product type
Prescription drug
Marketing category
NDA — New Drug ApplicationApplication NDA 020583
Marketing start
Listing expires
Other FDA classes
Corticosteroid Hormone Receptor Agonists (Mechanism)
Identifiers
Product ID 24208-299_ef44228f-e365-4d7f-b143-529257efffbeSPL ID ef44228f-e365-4d7f-b143-529257efffbeSPL set ID f37d74ac-5f9c-40a8-b43b-35148fc66bbeRxCUI 213263, 311382UNII 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

N424208029901 followed by a unit qualifier and the quantity

Package 24208-0299-01. 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 .

Indications (excerpt from the label)

INDICATIONS AND USAGE LOTEMAX 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. LOTEMAX is less effective than prednisolone acetate 1% in two 28-day controlled clinical studies in acute anterior uveitis, where 72% of patients treated with LOTEMAX experienced resolution of anterior chamber cells, compared to 87% of pat…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under NDA 020583

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

FDA NDC Directory listings under NDA 020583
ProductStrengthForm · routeLabelerProduct NDC
Loteprednol EtabonateLoteprednol etabonate 5 mg/mLSuspension/ dropsOphthalmicBausch & Lomb Americas Inc.82260-299

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