NDC 70165-030 Adzenys Xr-odt
Amphetamine Tablet, Orally Disintegrating Oral - View Dosage, Usage, Ingredients, Routes, UNII
Product Information
Product Characteristics
ORANGE (C48331)
4 MM
5 MM
6 MM
A2
A3
A4
A5
A6
Code Structure Chart
Product Details
What is NDC 70165-030?
What are the uses for Adzenys Xr-odt?
What are Adzenys Xr-odt Active Ingredients?
- AMPHETAMINE 18.8 mg/1 - A powerful central nervous system stimulant and sympathomimetic. Amphetamine has multiple mechanisms of action including blocking uptake of adrenergics and dopamine, stimulation of release of monamines, and inhibiting monoamine oxidase. Amphetamine is also a drug of abuse and a psychotomimetic. The l- and the d,l-forms are included here. The l-form has less central nervous system activity but stronger cardiovascular effects. The d-form is DEXTROAMPHETAMINE.
Which are Adzenys Xr-odt UNII Codes?
The UNII codes for the active ingredients in this product are:
- AMPHETAMINE (UNII: CK833KGX7E)
- AMPHETAMINE (UNII: CK833KGX7E) (Active Moiety)
Which are Adzenys Xr-odt Inactive Ingredients 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:
- MANNITOL (UNII: 3OWL53L36A)
- CROSPOVIDONE (15 MPA.S AT 5%) (UNII: 68401960MK)
- MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
- METHACRYLIC ACID (UNII: 1CS02G8656)
- SODIUM POLYSTYRENE SULFONATE (UNII: 1699G8679Z)
- CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
- FRUCTOSE (UNII: 6YSS42VSEV)
- SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
- TRIETHYL CITRATE (UNII: 8Z96QXD6UM)
- SUCRALOSE (UNII: 96K6UQ3ZD4)
- MAGNESIUM STEARATE (UNII: 70097M6I30)
- POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
What is the NDC to RxNorm Crosswalk for Adzenys Xr-odt?
- RxCUI: 1739803 - amphetamine 12.5 MG 24HR Extended Release Distintegrating Oral Tablet
- RxCUI: 1739803 - 24 HR amphetamine 12.5 MG Extended Release Oral Tablet
- RxCUI: 1739803 - amphetamine 12.5 MG 24 HR Extended Release Distintegrating Oral Tablet
- RxCUI: 1739809 - Adzenys XR-ODT 12.5 MG 24HR Extended Release Distintegrating Oral Tablet
- RxCUI: 1739809 - 24 HR amphetamine 12.5 MG Extended Release Oral Tablet [Adzenys]
Which are the Pharmacologic Classes for Adzenys Xr-odt?
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Patient Education
Amphetamine
Amphetamine (Adzenys ER, Adzenys XR, Dyanavel XR, Evekeo, Evekeo ODT, others) is used as part of a treatment program to control symptoms of attention deficit hyperactivity disorder (ADHD; more difficulty focusing, controlling actions, and remaining still or quiet than other people who are the same age) in adults and children. Amphetamine (Evekeo, others) is also used to treat narcolepsy (a sleep disorder that causes excessive daytime sleepiness and sudden attacks of sleep). Amphetamine (Evekeo, others) is also used for a limited period of time (a few weeks) along with a reduced calorie diet and an exercise plan for weight loss in obese people unable to lose weight. Amphetamine is in a class of medications called central nervous system stimulants. It works by changing the amounts of certain natural substances in the brain.
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[1] 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.
[2] 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.
[3] 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.
[4] What are the Administration Routes? - The translation of the route code submitted by the firm, indicating route of administration.
[5] What is the Labeler Name? - Name of Company corresponding to the labeler code segment of the Product NDC.
[6] 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.
[7] What is the Drug Enforcement Administration (DEA) CII Schedule? - This is the assigned DEA Schedule number as reported by the labeler. Values are CI, CII, CIII, CIV, and CV.
[8] 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.
[9] What is the Start Marketing Date? - This is the date that the labeler indicates was the start of its marketing of the drug product.
[11] What is the Listing Expiration Date? - This is the date when the listing record will expire if not updated or certified by the product labeler.
[12] 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 ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".