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NDC 45963-0304-09 dextroamphetamine sulfate 10 mg/1 Details
dextroamphetamine sulfate 10 mg/1
dextroamphetamine sulfate is a ORAL CAPSULE, EXTENDED RELEASE in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Actavis Pharma, Inc.. The primary component is DEXTROAMPHETAMINE SULFATE.
MedlinePlus Drug Summary
Dextroamphetamine 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. Dextroamphetamine is also used to treat narcolepsy (a sleep disorder that causes excessive daytime sleepiness and sudden attacks of sleep). Dextroamphetamine 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: 45963-0304-09Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Dextroamphetamine
Product Information
| NDC | 45963-0304 |
|---|---|
| Product ID | 45963-304_50d301c0-547c-4881-b618-c32987ca1f2a |
| Associated GPIs | 61100020107010 |
| GCN Sequence Number | 005005 |
| GCN Sequence Number Description | dextroamphetamine sulfate CAPSULE ER 10 MG ORAL |
| HIC3 | J5B |
| HIC3 Description | ADRENERGICS, AROMATIC, NON-CATECHOLAMINE |
| GCN | 19850 |
| HICL Sequence Number | 002065 |
| HICL Sequence Number Description | DEXTROAMPHETAMINE SULFATE |
| Brand/Generic | Generic |
| Proprietary Name | dextroamphetamine sulfate |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | dextroamphetamine sulfate |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | CAPSULE, EXTENDED RELEASE |
| Route | ORAL |
| Active Ingredient Strength | 10 |
| Active Ingredient Units | mg/1 |
| Substance Name | DEXTROAMPHETAMINE SULFATE |
| Labeler Name | Actavis Pharma, Inc. |
| Pharmaceutical Class | Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE] |
| DEA Schedule | CII |
| Marketing Category | ANDA |
| Application Number | ANDA203901 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 45963-0304-09 (45963030409)
| NDC Package Code | 45963-304-09 |
|---|---|
| Billing NDC | 45963030409 |
| Package | 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (45963-304-09) |
| Marketing Start Date | 2014-06-19 |
| NDC Exclude Flag | N |
| Pricing Information | |
| Price Per Unit | 0.75298 |
| Pricing Unit | EA |
| Effective Date | 2024-02-21 |
| NDC Description | DEXTROAMPHETAMINE ER 10 MG CAP |
| Pharmacy Type Indicator | C/I |
| OTC | N |
| Explanation Code | 1 |
| Classification for Rate Setting | G |
| As of Date | 2024-02-21 |