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NDC 43547-0457-10 AMPHETAMINE SULFATE 5 mg/1 Details
AMPHETAMINE SULFATE 5 mg/1
AMPHETAMINE SULFATE is a ORAL TABLET in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Solco Healthcare US, LLC. The primary component is AMPHETAMINE SULFATE.
MedlinePlus Drug Summary
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.
Related Packages: 43547-0457-10Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Amphetamine
Product Information
| NDC | 43547-0457 |
|---|---|
| Product ID | 43547-457_536d3653-93a1-4ae3-ac89-8fa23943bd96 |
| Associated GPIs | 61100010100310 |
| GCN Sequence Number | 005003 |
| GCN Sequence Number Description | amphetamine sulfate TABLET 5 MG ORAL |
| HIC3 | J5B |
| HIC3 Description | ADRENERGICS, AROMATIC, NON-CATECHOLAMINE |
| GCN | 19822 |
| HICL Sequence Number | 002064 |
| HICL Sequence Number Description | AMPHETAMINE SULFATE |
| Brand/Generic | Generic |
| Proprietary Name | AMPHETAMINE SULFATE |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | amphetamine sulfate |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | TABLET |
| Route | ORAL |
| Active Ingredient Strength | 5 |
| Active Ingredient Units | mg/1 |
| Substance Name | AMPHETAMINE SULFATE |
| Labeler Name | Solco Healthcare US, LLC |
| Pharmaceutical Class | Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE] |
| DEA Schedule | CII |
| Marketing Category | ANDA |
| Application Number | ANDA211861 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 43547-0457-10 (43547045710)
| NDC Package Code | 43547-457-10 |
|---|---|
| Billing NDC | 43547045710 |
| Package | 100 TABLET in 1 BOTTLE (43547-457-10) |
| Marketing Start Date | 2020-04-02 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |