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NDC 35573-0468-02 Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate 6.25; 6.25; 6.25; 6.25 mg/1; mg/1; mg/1; mg/1 Details
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate 6.25; 6.25; 6.25; 6.25 mg/1; mg/1; mg/1; mg/1
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate is a ORAL CAPSULE, EXTENDED RELEASE in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Burel Pharmaceuticals, LLC. The primary component is AMPHETAMINE ASPARTATE MONOHYDRATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE.
MedlinePlus Drug Summary
The combination of dextroamphetamine and amphetamine (Adderall, Adderall XR, Mydayis) 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). Adderall is used to treat ADHD in adults and children 3 years of age and older. Adderall XR is used to treat ADHD in adults and children 6 years of age and older. Mydayis is used to treat ADHD in adults and children 13 years of age and older. Dextroamphetamine and amphetamine (Adderall) is also used to treat narcolepsy (a sleep disorder that causes excessive daytime sleepiness and sudden attacks of sleep) in adults and children 12 years of age and older. The combination of dextroamphetamine and 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.
Related Packages: 35573-0468-02Last Updated: 03/24/2024
MedLinePlus Full Drug Details: Dextroamphetamine and Amphetamine
Product Information
| NDC | 35573-0468 |
|---|---|
| Product ID | 35573-468_7549ee4c-4fa3-4e7d-9864-580835d80d39 |
| Associated GPIs | |
| GCN Sequence Number | n/a |
| GCN Sequence Number Description | n/a |
| HIC3 | n/a |
| HIC3 Description | n/a |
| GCN | n/a |
| HICL Sequence Number | n/a |
| HICL Sequence Number Description | n/a |
| Brand/Generic | n/a |
| Proprietary Name | Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | CAPSULE, EXTENDED RELEASE |
| Route | ORAL |
| Active Ingredient Strength | 6.25; 6.25; 6.25; 6.25 |
| Active Ingredient Units | mg/1; mg/1; mg/1; mg/1 |
| Substance Name | AMPHETAMINE ASPARTATE MONOHYDRATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE |
| Labeler Name | Burel Pharmaceuticals, LLC |
| Pharmaceutical Class | Central Nervous System Stimulant [EPC], Central Nervous System Stimulant [EPC], Central Nervous System Stimulant [EPC], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Central Nervous System Stimulation [PE], Central Nervo |
| DEA Schedule | CII |
| Marketing Category | ANDA |
| Application Number | ANDA212037 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 35573-0468-02 (35573046802)
| NDC Package Code | 35573-468-02 |
|---|---|
| Billing NDC | 35573046802 |
| Package | 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (35573-468-02) |
| Marketing Start Date | 2019-12-16 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |