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NDC 71428-0001-60 Fluocinonide 0.5 mg/mL Details
Fluocinonide 0.5 mg/mL
Fluocinonide is a TOPICAL SOLUTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Glasshouse Pharmaceuticals Limited Canada. The primary component is FLUOCINONIDE.
MedlinePlus Drug Summary
Fluocinolone 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). Fluocinolone 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: 71428-0001-60Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Fluocinolone Topical
Fluocinonide 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). Fluocinonide 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: 71428-0001-60Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Fluocinonide Topical
Product Information
| NDC | 71428-0001 |
|---|---|
| Product ID | 71428-001_0e88c9e2-8dbc-917c-e063-6294a90a6ec9 |
| Associated GPIs | 90550060002005 |
| GCN Sequence Number | 007618 |
| GCN Sequence Number Description | fluocinonide SOLUTION 0.05 % TOPICAL |
| HIC3 | Q5P |
| HIC3 Description | TOPICAL ANTI-INFLAMMATORY STEROIDAL |
| GCN | 31401 |
| HICL Sequence Number | 003318 |
| HICL Sequence Number Description | FLUOCINONIDE |
| Brand/Generic | Generic |
| Proprietary Name | Fluocinonide |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Fluocinonide |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | SOLUTION |
| Route | TOPICAL |
| Active Ingredient Strength | 0.5 |
| Active Ingredient Units | mg/mL |
| Substance Name | FLUOCINONIDE |
| Labeler Name | Glasshouse Pharmaceuticals Limited Canada |
| Pharmaceutical Class | Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA209118 |
| Listing Certified Through | 2025-12-31 |
Package
NDC 71428-0001-60 (71428000160)
| NDC Package Code | 71428-001-60 |
|---|---|
| Billing NDC | 71428000160 |
| Package | 1 BOTTLE in 1 CARTON (71428-001-60) / 60 mL in 1 BOTTLE |
| Marketing Start Date | 2018-06-01 |
| NDC Exclude Flag | N |
| Pricing Information | |
| Price Per Unit | 0.30659 |
| Pricing Unit | ML |
| Effective Date | 2022-11-23 |
| NDC Description | FLUOCINONIDE 0.05% SOLUTION |
| Pharmacy Type Indicator | C/I |
| OTC | N |
| Explanation Code | 1, 5 |
| Classification for Rate Setting | G |
| As of Date | 2022-11-23 |