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NDC 63629-8657-01 Flurandrenolide 0.5 mg/mL Details
Flurandrenolide 0.5 mg/mL
Flurandrenolide is a TOPICAL LOTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Bryant Ranch Prepack. The primary component is FLURANDRENOLIDE.
MedlinePlus Drug Summary
Flurandrenolide topical is used to treat the itching, redness, dryness, crusting, scaling, inflammation, and discomfort of various skin conditions, including psoriasis (a skin disease in which red, scaly patches form on some areas of the body and eczema (a skin disease that causes the skin to be dry and itchy and to sometimes develop red, scaly rashes). Flurandrenolide is in a class of medications called corticosteroids. It works by activating natural substances in the skin to reduce swelling, redness, and itching.
Related Packages: 63629-8657-01Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Flurandrenolide Topical
Product Information
| NDC | 63629-8657 |
|---|---|
| Product ID | 63629-8657_00b804f5-7685-0b1d-e063-6294a90a5753 |
| Associated GPIs | |
| GCN Sequence Number | 007606 |
| GCN Sequence Number Description | flurandrenolide LOTION 0.05 % TOPICAL |
| HIC3 | Q5P |
| HIC3 Description | TOPICAL ANTI-INFLAMMATORY STEROIDAL |
| GCN | 31310 |
| HICL Sequence Number | 003313 |
| HICL Sequence Number Description | FLURANDRENOLIDE |
| Brand/Generic | Generic |
| Proprietary Name | Flurandrenolide |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Flurandrenolide |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | LOTION |
| Route | TOPICAL |
| Active Ingredient Strength | 0.5 |
| Active Ingredient Units | mg/mL |
| Substance Name | FLURANDRENOLIDE |
| Labeler Name | Bryant Ranch Prepack |
| Pharmaceutical Class | Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA207133 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 63629-8657-01 (63629865701)
| NDC Package Code | 63629-8657-1 |
|---|---|
| Billing NDC | 63629865701 |
| Package | 1 BOTTLE, PLASTIC in 1 CARTON (63629-8657-1) / 120 mL in 1 BOTTLE, PLASTIC |
| Marketing Start Date | 2016-10-06 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |