Prescription drug · NDA
Alrex (Loteprednol etabonate) NDC 24208-353
Loteprednol etabonate 2 mg/mL · Suspension/ drops · Ophthalmic · Bausch & Lomb Incorporated
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 24208-353-01 | 2420803530124208035301 | 1 BOTTLE, DROPPER in 1 CARTON (24208-353-01) / 1 mL in 1 BOTTLE, DROPPERMarketed from Mar 9, 1998 · Sample package | |
| 24208-353-05 | 2420803530524208035305 | 1 BOTTLE, DROPPER in 1 CARTON (24208-353-05) / 5 mL in 1 BOTTLE, DROPPERMarketed from Mar 9, 1998 | |
| 24208-353-10 | 2420803531024208035310 | 1 BOTTLE, DROPPER in 1 CARTON (24208-353-10) / 10 mL in 1 BOTTLE, DROPPERMarketed from Mar 9, 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)
- Alrex
- Generic name (nonproprietary)
- loteprednol etabonate
- Active ingredients
- Loteprednol etabonate — 2 mg/mL
- Dosage form
- Suspension/ drops
- Route
- Ophthalmic
- Labeler
- Bausch & Lomb IncorporatedNDC labeler code 24208
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 020803
- Marketing start
- Listing expires
- Other FDA classes
- Corticosteroid Hormone Receptor Agonists (Mechanism)
- Identifiers
- Product ID 24208-353_138577af-1a4e-48fb-b088-47f54c896442SPL ID 138577af-1a4e-48fb-b088-47f54c896442SPL set ID 21c76da0-50a1-41c0-91b8-8cc4dcc27f60RxCUI 213262, 311381UNII YEH1EZ96K6UPC 0324208353103
- 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
N424208035301followed by a unit qualifier and the quantityPackage 24208-0353-01. 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 ALREX ophthalmic suspension is indicated for the temporary relief of the signs and symptoms of seasonal allergic conjunctivitis.
Excerpt only. Read the full label for complete information.
About NDC 24208-353
- What is NDC 24208-353?
- 24208-353 is the product NDC for Alrex (loteprednol etabonate), Loteprednol etabonate 2 mg/mL suspension/ drops, listed with the FDA by Bausch & Lomb Incorporated. It has 3 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Alrex (Loteprednol etabonate).
- What is the active ingredient?
- Loteprednol etabonate.
- Who is the labeler?
- Bausch & Lomb Incorporated, NDC labeler code 24208. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Alrex?
- None: this is the only finished product listed under this name.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Other NDCs under NDA 020803
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 | Loteprednol etabonate 2 mg/mL | Suspension/ dropsOphthalmic | Bausch & Lomb Americas Inc. | 82260-361 |