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NDC 70165-0015-30 Adzenys XR-ODT 9.4 mg/1 Details
Adzenys XR-ODT 9.4 mg/1
Adzenys XR-ODT is a ORAL TABLET, ORALLY DISINTEGRATING in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Neos Therapeutics Brands, LLC. 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: 70165-0015-30Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Amphetamine
Product Information
| NDC | 70165-0015 |
|---|---|
| Product ID | 70165-015_0cf33da6-d664-3c5e-e063-6394a90ae5ac |
| Associated GPIs | 6110001000H430 |
| GCN Sequence Number | 075546 |
| GCN Sequence Number Description | amphetamine TAB RAP BP 9.4 MG ORAL |
| HIC3 | J5B |
| HIC3 Description | ADRENERGICS, AROMATIC, NON-CATECHOLAMINE |
| GCN | 40649 |
| HICL Sequence Number | 043652 |
| HICL Sequence Number Description | AMPHETAMINE |
| Brand/Generic | Brand |
| Proprietary Name | Adzenys XR-ODT |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Amphetamine |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | TABLET, ORALLY DISINTEGRATING |
| Route | ORAL |
| Active Ingredient Strength | 9.4 |
| Active Ingredient Units | mg/1 |
| Substance Name | AMPHETAMINE |
| Labeler Name | Neos Therapeutics Brands, LLC |
| Pharmaceutical Class | Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE] |
| DEA Schedule | CII |
| Marketing Category | NDA |
| Application Number | NDA204326 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 70165-0015-30 (70165001530)
| NDC Package Code | 70165-015-30 |
|---|---|
| Billing NDC | 70165001530 |
| Package | 30 BLISTER PACK in 1 CARTON (70165-015-30) / 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK |
| Marketing Start Date | 2016-02-16 |
| NDC Exclude Flag | N |
| Pricing Information | |
| Price Per Unit | 15.2597 |
| Pricing Unit | EA |
| Effective Date | 2024-02-21 |
| NDC Description | ADZENYS XR-ODT 9.4 MG TABLET |
| Pharmacy Type Indicator | C/I |
| OTC | N |
| Explanation Code | 1 |
| Classification for Rate Setting | B |
| As of Date | 2024-02-21 |