Fluocinolone Acetonide
Amneal Pharmaceuticals Llc
Human Prescription Drug
NDC 65162-703Fluocinolone Acetonide is a human prescription drug labeled by 'Amneal Pharmaceuticals Llc'. National Drug Code (NDC) number for Fluocinolone Acetonide is 65162-703. This drug is available in dosage form of Oil. The names of the active, medicinal ingredients in Fluocinolone Acetonide drug includes Fluocinolone Acetonide - .11 mg/118.28mL . The currest status of Fluocinolone Acetonide drug is Active.
Drug Information:
| Drug NDC: | 65162-703 |
| The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC. |
| Proprietary Name: | Fluocinolone Acetonide |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Product Type: | Human Prescription Drug |
| Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing. |
| Non Proprietary Name: | Fluocinolone Acetonide |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Amneal Pharmaceuticals Llc |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Oil |
| The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources. |
| Status: | Active |
| FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved. |
| Substance Name: | FLUOCINOLONE ACETONIDE - .11 mg/118.28mL
|
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | TOPICAL
|
| The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
Marketing Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Marketing Category: | ANDA |
| Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (ANDA), BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
| Marketing Start Date: | 22 Sep, 2015 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 24 Jun, 2026 |
| This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached. |
| Application Number: | ANDA201759 |
| This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null. |
| Listing Expiration Date: | 31 Dec, 2023 |
| This is the date when the listing record will expire if not updated or certified by the firm. |
OpenFDA Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Manufacturer Name: | Amneal Pharmaceuticals LLC
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 1191307
|
| The RxNorm Concept Unique Identifier. RxCUI is a unique number that describes a semantic concept about the drug product, including its ingredients, strength, and dose forms. |
| Original Packager: | Yes
|
| Whether or not the drug has been repackaged for distribution. |
| UPC: | 0365162703863
|
| UPC stands for Universal Product Code. |
| NUI: | N0000175576
N0000175450
|
| Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT). |
| UNII: | 0CD5FD6S2M
|
| Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information. |
| Pharmacologic Class MOA: | Corticosteroid Hormone Receptor Agonists [MoA]
|
| Mechanism of action of the drug—molecular, subcellular, or cellular functional activity—of the drug’s established pharmacologic class. Takes the form of the mechanism of action, followed by `[MoA]` (such as `Calcium Channel Antagonists [MoA]` or `Tumor Necrosis Factor Receptor Blocking Activity [MoA]`. |
| Pharmacologic Class EPC: | Corticosteroid [EPC]
|
| Established pharmacologic class associated with an approved indication of an active moiety (generic drug) that the FDA has determined to be scientifically valid and clinically meaningful. Takes the form of the pharmacologic class, followed by `[EPC]` (such as `Thiazide Diuretic [EPC]` or `Tumor Necrosis Factor Blocker [EPC]`. |
| Pharmacologic Class: | Corticosteroid Hormone Receptor Agonists [MoA]
Corticosteroid [EPC]
|
| These are the reported pharmacological class categories corresponding to the SubstanceNames listed above. |
Packaging Information:
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 65162-703-86 | 1 BOTTLE in 1 CARTON (65162-703-86) / 118.28 mL in 1 BOTTLE | 22 Sep, 2015 | N/A | No |
| Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together. |
Product Elements:
Fluocinolone acetonide fluocinolone acetonide fluocinolone acetonide fluocinolone acetonide isopropyl alcohol isopropyl myristate light mineral oil peanut oil oleth-2
Indications and Usage:
Indications and usage fluocinolone acetonide 0.01% topical oil is a low to medium potency corticosteroid indicated: in adult patients for the treatment of psoriasis of the scalp (scalp oil).
Dosage and Administration:
Dosage and administration fluocinolone acetonide 0.01% topical oil for scalp psoriasis in adults (scalp oil): for the treatment of scalp psoriasis, wet or dampen hair and scalp thoroughly. apply a thin film of fluocinolone acetonide 0.01% topical oil on the scalp, massage well and cover scalp with the supplied shower cap. leave on overnight, or for a minimum of 4 hours before washing off. wash hair with regular shampoo and rinse thoroughly.
Contraindications:
Contraindications fluocinolone acetonide 0.01% topical oil is contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation. this product contains refined peanut oil nf (see precautions section).
Adverse Reactions:
Adverse reactions the following local adverse reactions have been reported infrequently with topical corticosteroids. they may occur more frequently with the use of occlusive dressings, especially with higher potency corticosteroids. these reactions are listed in an approximate decreasing order of occurrence: burning, itching, irritation, dryness, folliculitis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, skin atrophy, striae, and malaria. one peanut sensitive child experienced a flare of his atopic dermatitis after 5 days of twice daily treatment with fluocinolone acetonide oil 0.01%. a post marketing (open-label) safety study was conducted in 58 children to evaluate the local safety of fluocinolone acetonide 0.01% topical oil when applied twice daily for 4 weeks to the face in children (2 to 12 years) with moderate to severe atopic dermatitis (see table of incidence of adverse events). incidence of adverse events (%) n=
Read more...58 adverse event (ae)* # of patients (%) day 14 day 28** day 56*** any ae 15 (25.9) 6 (10.3) 7 (12.1) 7 (12.1) telangiectasia 5 (8.6) 3 (5.2) 4 (6.9) 2 (3.5) erythema 3 (5.2) 3 (5.2) itching 3 (5.2) 3 (5.2) irritation 3 (5.2) 3 (5.2) burning 3 (5.2) 3 (5.2) hypopigmentation 2 (3.5) 2 (3.5) shiny skin 1 (1.7) 1 (1.7) secondary atopic dermatitis 1 (1.7) 1 (1.7) papules and pustules 1 (1.7) 1 (1.7) keratosis pilaris 1 (1.7) 1 (1.7) folliculitis 1 (1.7) 1 (1.7) facial herpes simplex 1 (1.7) 1 (1.7) acneiform eruption 1 (1.7) 1 (1.7) ear infection 1 (1.7) 1 (1.7) *the number of individual adverse events reported does not necessarily reflect the number of individual subjects, since one subject could have multiple reporting of an adverse event. **end of treatment ***four weeks post treatment
Adverse Reactions Table:
| Incidence of Adverse Events (%) |
| N=58 |
| Adverse Event (AE)* | # of patients (%) | Day 14 | Day 28** | Day 56*** |
| Any AE | 15 (25.9) | 6 (10.3) | 7 (12.1) | 7 (12.1) |
| Telangiectasia | 5 (8.6) | 3 (5.2) | 4 (6.9) | 2 (3.5) |
| Erythema | 3 (5.2) | | | 3 (5.2) |
| Itching | 3 (5.2) | | | 3 (5.2) |
| Irritation | 3 (5.2) | | | 3 (5.2) |
| Burning | 3 (5.2) | | | 3 (5.2) |
| Hypopigmentation | 2 (3.5) | 2 (3.5) | | |
| Shiny skin | 1 (1.7) | | 1 (1.7) | |
| Secondary atopic dermatitis | 1 (1.7) | | | 1 (1.7) |
| Papules and pustules | 1 (1.7) | | | 1 (1.7) |
| Keratosis pilaris | 1 (1.7) | | | 1 (1.7) |
| Folliculitis | 1 (1.7) | | 1 (1.7) | |
| Facial herpes simplex | 1 (1.7) | 1 (1.7) | | |
| Acneiform eruption | 1 (1.7) | | 1 (1.7) | |
| Ear infection | 1 (1.7) | | 1 (1.7) | |
Overdosage:
Overdosage topically applied fluocinolone acetonide 0.01% topical oil can be absorbed in sufficient amounts to produce systemic effects (see precautions ).
Description:
Description fluocinolone acetonide 0.01 % topical oil contains fluocinolone acetonide {(6α, 11β, 16α)-6,9-difluoro-11,21-dihydroxy-16,17[(1-methylethylidene)bis(oxy)]-pregna-1,4-diene-3,20-dione, cyclic 16,17 acetal with acetone}, a synthetic corticosteroid for topical use dermatologic use. this formulation is also marketed as fluocinolone acetonide 0.01% topical oil for use as body oil for atopic dermatitis in adults and for moderate to severe atopic dermatitis in pediatric patients 2 years and older, and as fluocinolone acetonide oil, 0.01% for chronic eczematous external otitis. chemically, fluocinolone acetonide is c 24 h 30 f 2 o 6 . it has the following structural formula: fluocinolone acetonide in fluocinolone acetonide 0.01% topical oil has a molecular weight of 452.50. it is a white crystalline powder that is odorless, stable in light, and melts at 270ºc with decomposition; soluble in alcohol, acetone and methanol; slightly soluble in chloroform; insoluble in water. each gram of fluocinolone acetonide 0.01% topical oil contains approximately 0.11 mg of fluocinolone acetonide in a blend of oils, which contains isopropyl alcohol, isopropyl myristate, light mineral oil, oleth-2, and refined peanut oil nf. each packaged product contains 2 shower caps. the shower cap is made of low density polyethylene material with rubber elastic. 32207a82-figure-01
Clinical Pharmacology:
Clinical pharmacology like other topical corticosteroids, fluocinolone acetonide has anti-inflammatory, antipruritic, and vasoconstrictive properties. the mechanism of the anti-inflammatory activity of the topical steroids, in general, is unclear. however, corticosteroids are thought to act by the induction of phospholipase a 2 inhibitory proteins, collectively called lipocortins. it is postulated that these proteins control the biosynthesis of potent mediators of inflammation such as prostaglandins and leukotrienes by inhibiting the release of their common precursor arachidonic acid. arachidonic acid is released from membrane phospholipids by phospholipase a 2 . pharmacokinetics: the extent of percutaneous absorption of topical corticosteroids is determined by many factors including the vehicle and the integrity of the epidermal barrier. occlusion of topical corticosteroids can enhance penetration. topical corticosteroids can be absorbed from normal intact skin. also, inflammation and
Read more.../or other disease processes in the skin can increase percutaneous absorption. fluocinolone acetonide 0.01% topical oil is in the low to medium range of potency as compared with other topical corticosteroids.
How Supplied:
How supplied fluocinolone acetonide 0.01% topical oil is supplied in a 4 fluid ounce bottle with a net content of 118.28 ml. it is labeled as scalp oil (ndc 65162-703-86). scalp oil is supplied with 2 shower caps. keep tightly closed. store upright at 20° to 25°c (68° to 77°f); excursions permitted to 15° to 30°c (59° to 86°f) [see usp controlled room temperature]. to report suspected adverse reactions, contact amneal pharmaceuticals at 1-877-835-5472 or www.amneal.com or fda at 1-800-fda-1088 or www.fda.gov/medwatch. caution: rx only distributed by: amneal pharmaceuticals bridgewater, nj 08807 rev. 08-2015-00
Package Label Principal Display Panel:
Package label.principal display panel 32207a82-figure-02