Prescription drug · ANDA
Loteprednol Etabonate NDC 70244-034
Loteprednol etabonate 5 mg/mL · Suspension/ drops · Ophthalmic · Sentiss Pharmaceuticals LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70244-034-01 | 7024400340170244003401 | 1 BOTTLE, DROPPER in 1 CARTON (70244-034-01) / 5 mL in 1 BOTTLE, DROPPERMarketed from Apr 17, 2026 | |
| 70244-034-02 | 7024400340270244003402 | 1 BOTTLE, DROPPER in 1 CARTON (70244-034-02) / 10 mL in 1 BOTTLE, DROPPERMarketed from Apr 17, 2026 | |
| 70244-034-03 | 7024400340370244003403 | 1 BOTTLE, DROPPER in 1 CARTON (70244-034-03) / 15 mL in 1 BOTTLE, DROPPERMarketed from Apr 17, 2026 |
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
- Generic name (nonproprietary)
- loteprednol etabonate
- Active ingredients
- Loteprednol etabonate — 5 mg/mL
- Dosage form
- Suspension/ drops
- Route
- Ophthalmic
- Labeler
- Sentiss Pharmaceuticals LLCNDC labeler code 70244
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 207609
- Marketing start
- Listing expires
- Other FDA classes
- Corticosteroid Hormone Receptor Agonists (Mechanism)
- Identifiers
- Product ID 70244-034_4faa8338-1297-3876-e063-6294a90a42faSPL ID 4faa8338-1297-3876-e063-6294a90a42faSPL set ID 4faa8cbe-2004-e8b5-e063-6394a90a3550RxCUI 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
N470244003401followed by a unit qualifier and the quantityPackage 70244-0034-01. 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 Loteprednol etabonate 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. Loteprednol etabonate is less effective than prednisolone acetate 1% in two 28-day controlled clinical studies in acute anterior uveitis, where 72% of patients treated with loteprednol etabonate experienced resolution of ante…
Excerpt only. Read the full label for complete information.
About NDC 70244-034
- What is NDC 70244-034?
- 70244-034 is the product NDC for Loteprednol Etabonate, Loteprednol etabonate 5 mg/mL suspension/ drops, listed with the FDA by Sentiss Pharmaceuticals LLC. It has 3 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Loteprednol Etabonate.
- What is the active ingredient?
- Loteprednol etabonate.
- Who is the labeler?
- Sentiss Pharmaceuticals LLC, NDC labeler code 70244. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Loteprednol Etabonate?
- 18 other product NDCs are listed under this name. See all Loteprednol Etabonate NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Loteprednol Etabonate products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Loteprednol Etabonate | Loteprednol etabonate 2 mg/mL | Suspension/ dropsOphthalmic | Sentiss Pharmaceuticals LLC | 70244-035 | 70244-0035-0170244-0035-02 |
| Loteprednol Etabonate | Loteprednol etabonate 5 mg/g | GelOphthalmic | Sentiss Pharmaceuticals LLC | 70244-036 | 70244-0036-01 |
| Loteprednol Etabonate | Loteprednol etabonate 2 mg/mL | Suspension/ dropsOphthalmic | Padagis US LLC | 0574-4080 | 00574-4080-0500574-4080-10 |
| Loteprednol Etabonate | Loteprednol etabonate 5 mg/mL | Suspension/ dropsOphthalmic | Padagis US LLC | 0574-4135 | 00574-4135-0500574-4135-1000574-4135-15 |
| loteprednol etabonate | Loteprednol etabonate 5 mg/mL | SuspensionOphthalmic | Lupin Pharmaceuticals, Inc. | 70748-300 | 70748-0300-0170748-0300-02 |
| Loteprednol Etabonate | Loteprednol etabonate 5 mg/mL | Suspension/ dropsOphthalmic | Amneal Pharmaceuticals NY LLC | 60219-1362 | 60219-1362-0160219-1362-0260219-1362-03 |
| loteprednol etabonate | Loteprednol etabonate 2 mg/mL | Suspension/ dropsOphthalmic | Amneal Pharmaceuticals NY LLC | 60219-1366 | 60219-1366-03 |
| loteprednol etabonate | Loteprednol etabonate 2 mg/mL | Suspension/ dropsOphthalmic | Amneal Pharmaceuticals NY LLC | 60219-1367 | 60219-1367-06 |
| Loteprednol Etabonate | Loteprednol etabonate 5 mg/mL | Suspension/ dropsOphthalmic | NorthStar RxLLC | 72603-324 | 72603-0324-01 |
| loteprednol etabonate | Loteprednol etabonate 2 mg/mL | Suspension/ dropsOphthalmic | Bausch & Lomb Americas Inc. | 82260-361 | 82260-0361-05 |
Other NDCs under ANDA 207609
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 5 mg/mL | Suspension/ dropsOphthalmic | ARMAS PHARMACEUTICALS INC. | 72485-665 |