50383-265 : Loteprednol Etabonate 5 mg/ml Ophthalmic Suspension/ Drops


NDC50383-265
Labeler: Hi-tech Pharmacal Co., Inc.
Product Type: Human Prescription Drug
Drug Name: Loteprednol Etabonate
Dosage Form: Ophthalmic Suspension/ Drops
Application #: ANDA207609
Rev. Date: 


NDC Package Codes:

  • 50383-265-02: 1 BOTTLE, DROPPER IN 1 CARTON (50383‑265‑02) > 5 ML IN 1 BOTTLE, DROPPER
  • 50383-265-05: 1 BOTTLE, DROPPER IN 1 CARTON (50383‑265‑05) > 5 ML IN 1 BOTTLE, DROPPER
  • 50383-265-10: 1 BOTTLE, DROPPER IN 1 CARTON (50383‑265‑10) > 10 ML IN 1 BOTTLE, DROPPER
  • 50383-265-15: 1 BOTTLE, DROPPER IN 1 CARTON (50383‑265‑15) > 15 ML IN 1 BOTTLE, DROPPER

Active Ingredients:

  • Loteprednol Etabonate

Dosage Strength:

  • 5 mg/mL

Pharmaceutical Classes:

  • Corticosteroid [EPC]
  • Corticosteroid Hormone Receptor Agonists [MoA]

Related Products:

Based on records with the same trade name.
  • 17478-830 Loteprednol Etabonate 5 mg/g Ophthalmic Gel by Akorn, Inc.
  • 24208-508 Loteprednol Etabonate 5 mg/g Ophthalmic Gel by Bausch & Lomb Incorporated
  • 62756-232 Loteprednol Etabonate 5 mg/ml Ophthalmic Suspension/ Drops by Sun Pharmaceutical Industries, Inc.
  • 68682-299 Loteprednol Etabonate 5 mg/ml Ophthalmic Suspension/ Drops by Oceanside Pharmaceuticals
  • 72485-630 Loteprednol Etabonate 5 mg/g Ophthalmic Gel by Armas Pharmaceuticals Inc.
  • 72485-653 Loteprednol Etabonate 2 mg/ml Ophthalmic Suspension/ Drops by Armas Pharmaceuticals Inc.
  • 72485-665 Loteprednol Etabonate 5 mg/ml Ophthalmic Suspension/ Drops by Armas Pharmaceuticals Inc.
  • 82260-299 Loteprednol Etabonate 5 mg/ml Ophthalmic Suspension/ Drops by Bausch & Lomb Americas Inc.
  • 82260-508 Loteprednol Etabonate 5 mg/g Ophthalmic Gel by Bausch & Lomb Americas Inc.

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Note: The RxChat NDC Database uses publicly available data from the FDA and the U.S. National Library of Medicine (NLM); The NLM is not responsible for the data presented and does not endorse or recommend this or any other product. While we make every effort to ensure that the information presented is accurate, you should assume that all results are unvalidated. To report any errors or inconsistencies please contact us.