Fluocinolone Acetonide
Amneal Pharmaceuticals Llc
Human Prescription Drug
NDC 65162-702Fluocinolone Acetonide is a human prescription drug labeled by 'Amneal Pharmaceuticals Llc'. National Drug Code (NDC) number for Fluocinolone Acetonide is 65162-702. 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/20mL . The currest status of Fluocinolone Acetonide drug is Active.
Drug Information:
| Drug NDC: | 65162-702 |
| 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/20mL
|
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | AURICULAR (OTIC)
|
| 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: | 18 Jan, 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: | ANDA091306 |
| 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: | 1191299
|
| 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. |
| 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 |
|---|
| 65162-702-94 | 1 BOTTLE in 1 CARTON (65162-702-94) / 20 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 oil 0.01% is a low to medium potency corticosteroid indicated for the treatment of chronic eczematous external otitis in adults and pediatric patients 2 years old and older.
Dosage and Administration:
Dosage and administration for the treatment of chronic eczematous external otitis, using the supplied ear-dropper, apply 5 drops of fluocinolone acetonide oil 0.01% into the affected ear. to apply, tilt head to one side so that the ear is facing up. then gently pull the ear lobe backward and upward and apply 5 drops of fluocinolone acetonide oil 0.01% into the ear. keep head tilted for about a minute to allow fluocinolone acetonide oil 0.01% to penetrate lower into the ear canal. gently pat excess material dripping out of the ear using a clean cotton ball. follow these instructions twice each day for 7 to 14 days.
Contraindications:
Contraindications fluocinolone acetonide oil 0.01% 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 ).
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 miliaria.
Overdosage:
Overdosage topically applied fluocinolone acetonide oil 0.01% can be absorbed in sufficient amounts to produce systemic effects (see precautions ).
Description:
Description fluocinolone acetonide oil 0.01% ear drops contain 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. chemically, fluocinolone acetonide is c 24 h 30 f 2 o 6 anhydrous. it has the following structural formula: fluocinolone acetonide in fluocinolone acetonide oil 0.01% has a molecular weight of 452.49. 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 oil 0.01% 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. 79cc0041-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 oil 0.01% is in the low to medium range of potency as compared with other topical corticosteroids.
How Supplied:
How supplied fluocinolone acetonide oil 0.01% ear drops is supplied in 1 fluid ounce bottles with a net contents of 20 ml (dropper included) (ndc # 65162-702-94). keep tightly closed. store 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 79cc0041-figure-02