Spinosad Suspension
NDC 28595-570
View dosage, usage, ingredients, routes, and UNII mappings.
Product Information
Spinosad is a NDA AUTHORIZED GENERIC-approved product labeled by Allegis Pharmaceuticals, Llc. This medication is used to treat head lice, tiny insects that infest and irritate your scalp. It is supplied as a orange suspension for topical administration. This product entry covers the primary NDC 28595-570 and its associated package configuration. This profile includes active and inactive ingredient UNII references and FDA labeling data.
Primary Identification
NDC Product Code:
28595-570
Proprietary Name:
Spinosad
Non-Proprietary Name: [1]
Spinosad
Substance Name: [2]
Spinosad
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Code Navigator:
Clinical Specifications
Dosage Form:
Suspension
- A liquid1 dosage form that contains solid particles dispersed in a liquid vehicle.
Administration Route(s): [4]
Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.
Labeler & Regulatory Data
Labeler Name: [5]
Labeler Code:
28595
Product Label ID:
FDA Application Number: [6]
NDA022408
Marketing Category: [8]
NDA AUTHORIZED GENERIC - A product marketed as a "generic" drug under an approved New Drug Application (NDA), rather than an Abbreviated New Drug Application (ANDA),.
Marketing Timeline
Start Marketing Date: [9]
06-25-2014
End Marketing Date: [10]
06-30-2027
Exclude Flag: [12]
N
Product Characteristics
Color(s):
ORANGE (C48331 - PEARLESCENT LIGHT ORANGE)
Code Structure Chart
Product Details
What is NDC 28595-570?
The NDC code 28595-570 is assigned by the FDA to the product Spinosad. This pharmaceutical product is labeled by Allegis Pharmaceuticals, Llc and is currently categorized as listed product. The medication is a suspension administered via topical route. In terms of distribution, this product is available in a single package configuration. The associated package NDC(s) include: 28595-570-04. Beyond standard identification, this entry provides technical data including pharmacologic classes, UNII ingredient references, and RxNorm cross-referencing for healthcare systems.
What are the uses of this product?
This medication is used to treat head lice, tiny insects that infest and irritate your scalp. Head lice lay small white eggs (nits) at the roots of hair close to the scalp, especially on the hairline at the back of the neck and behind the ears. Spinosad works by paralyzing and killing lice and their eggs. This medication should not be used on infants younger than 6 months due to the increased risk for serious side effects.
What are Active Ingredients of this product?
An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
- SPINOSAD 9 mg/mL - combination of spinosyns A and D; isolated from Saccharopolyspora spinosa
Which are the associated UNII Codes?
The UNII codes for the active ingredients in this product are:
- SPINOSAD (UNII: XPA88EAP6V)
- SPINOSAD (UNII: XPA88EAP6V) (Active Moiety)
Which are the Inactive Ingredients associated UNII Codes?
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product. The UNII codes for the inactive ingredients in this product are:
- WATER (UNII: 059QF0KO0R)
What is the NDC to RxNorm Crosswalk for this product?
RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:
- RxCUI: 1085816 - spinosad 0.9 % Topical Suspension
- RxCUI: 1085816 - spinosad 9 MG/ML Medicated Shampoo
- RxCUI: 1085816 - spinosad 0.9 % Medicated Shampoo
Which are the Pharmacologic Classes of this product?
A pharmacologic class is a group of drugs that share the same scientifically documented properties. The following is a list of the reported pharmacologic class(es) corresponding to the active ingredients of this product.
* Please review the full disclaimer at the bottom of this page.
Patient Education
Spinosad Topical
Spinosad suspension is used to treat head lice (small insects that attach themselves to the scalp) in adults and children 6 months of age and older. It is also used to treat scabies (mites that attach themselves to the skin) in adults and children 4 years of age and older. Spinosad is in a class of medications called pediculicides. It works by killing the lice and mites.
[Learn More]
* Please review the full disclaimer at the bottom of this page.
Product & Regulatory Definitions
What is the Non-Proprietary Name? The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
What is the Substance Name? An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
What kind of product is this? Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.
What are the Administration Routes? The translation of the route code submitted by the firm, indicating route of administration.
What is the Labeler Name? Name of Company corresponding to the labeler code segment of the Product NDC.
What is the FDA Application Number? 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.
What is the Marketing Category? Product types are broken down into several potential Marketing Categories, such as NDA/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.
What is the Start Marketing Date? This is the date that the labeler indicates was the start of its marketing of the drug product.
What is the End Marketing Date? 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.
What is the NDC Exclude Flag? This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions, or because the listing certification is expired, or because the listing data was inactivated by FDA, or because it was discontinued by the labeler. Possible values in this field are: "D", "E", "I", "N", "U".
