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NDC 24208-0507-01 Lotemax SM 3.8 mg/g Details
Lotemax SM 3.8 mg/g
Lotemax SM is a OPHTHALMIC GEL in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Bausch & Lomb Incorporated. The primary component is LOTEPREDNOL ETABONATE.
MedlinePlus Drug Summary
Ophthalmic loteprednol products are used to treat different eye conditions: Loteprednol (Inveltys, Lotemax, Lotemax SM) is used to treat swelling and pain after cataract surgery (procedure to treat clouding of the lens in the eye). Loteprednol (Alrex) is used to reduce eye redness, itching, and swelling caused by seasonal allergies. Loteprednol (Lotemax) is used to reduce eye swelling caused by allergies, certain eye infections, ocular rosacea (condition that can cause swelling, redness, and itching of the eye), herpes zoster (shingles; a rash that can occur in people who have had chickenpox in the past and can affect the eyes), and other eye conditions. Loteprednol (Eysuvis) is used to treat dry eye disease (an eye disorder in which tears do not provide sufficient eye lubrication). Loteprednol is in a class of medications called corticosteroids. It works by stopping the release of certain natural substances that cause swelling, itching, and pain.
Related Packages: 24208-0507-01Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Loteprednol Ophthalmic
Product Information
| NDC | 24208-0507 |
|---|---|
| Product ID | 24208-507_91998c80-00ef-40b9-8316-c95b6e4aa713 |
| Associated GPIs | 86300035104015 |
| GCN Sequence Number | 079545 |
| GCN Sequence Number Description | loteprednol etabonate DROPS GEL 0.38 % OPHTHALMIC |
| HIC3 | Q6P |
| HIC3 Description | EYE ANTI-INFLAMMATORY AGENTS |
| GCN | 46053 |
| HICL Sequence Number | 018026 |
| HICL Sequence Number Description | LOTEPREDNOL ETABONATE |
| Brand/Generic | Brand |
| Proprietary Name | Lotemax SM |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | loteprednol etabonate |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | GEL |
| Route | OPHTHALMIC |
| Active Ingredient Strength | 3.8 |
| Active Ingredient Units | mg/g |
| Substance Name | LOTEPREDNOL ETABONATE |
| Labeler Name | Bausch & Lomb Incorporated |
| Pharmaceutical Class | Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC] |
| DEA Schedule | n/a |
| Marketing Category | NDA |
| Application Number | NDA208219 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 24208-0507-01 (24208050701)
| NDC Package Code | 24208-507-01 |
|---|---|
| Billing NDC | 24208050701 |
| Package | 1 BOTTLE in 1 CARTON (24208-507-01) / .5 g in 1 BOTTLE |
| Marketing Start Date | 2019-02-25 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |