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NDC 24478-0108-01 DYANAVEL XR 10 mg/1 Details
DYANAVEL XR 10 mg/1
DYANAVEL XR is a ORAL TABLET, EXTENDED RELEASE in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by NextWave Pharmaceuticals, Inc. The primary component is AMPHETAMINE.
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: 24478-0108-01Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Amphetamine
Product Information
| NDC | 24478-0108 |
|---|---|
| Product ID | 24478-108_4502ddc0-0a4f-4af3-bd41-8bbe0de0e774 |
| Associated GPIs | |
| GCN Sequence Number | 082800 |
| GCN Sequence Number Description | amphetamine TAB BP 24H 10 MG ORAL |
| HIC3 | J5B |
| HIC3 Description | ADRENERGICS, AROMATIC, NON-CATECHOLAMINE |
| GCN | 51452 |
| HICL Sequence Number | 043652 |
| HICL Sequence Number Description | AMPHETAMINE |
| Brand/Generic | Brand |
| Proprietary Name | DYANAVEL XR |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | amphetamine |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | TABLET, EXTENDED RELEASE |
| Route | ORAL |
| Active Ingredient Strength | 10 |
| Active Ingredient Units | mg/1 |
| Substance Name | AMPHETAMINE |
| Labeler Name | NextWave Pharmaceuticals, Inc |
| Pharmaceutical Class | Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE] |
| DEA Schedule | CII |
| Marketing Category | NDA |
| Application Number | NDA210526 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 24478-0108-01 (24478010801)
| NDC Package Code | 24478-108-01 |
|---|---|
| Billing NDC | 24478010801 |
| Package | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (24478-108-01) |
| Marketing Start Date | 2022-08-01 |
| NDC Exclude Flag | N |
| Pricing Information | |
| Price Per Unit | 14.2437 |
| Pricing Unit | EA |
| Effective Date | 2024-01-08 |
| NDC Description | DYANAVEL XR 10 MG TABLET |
| Pharmacy Type Indicator | C/I |
| OTC | N |
| Explanation Code | 4 |
| Classification for Rate Setting | B |
| As of Date | 2024-02-21 |