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NDC 65162-0028-09 Lisdexamfetamine Dimesylate 70 mg/1 Details
Lisdexamfetamine Dimesylate 70 mg/1
Lisdexamfetamine Dimesylate is a ORAL CAPSULE in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Amneal Pharmaceuticals LLC. The primary component is LISDEXAMFETAMINE DIMESYLATE.
MedlinePlus Drug Summary
Lisdexamfetamine 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 6 years of age and older. Lisdexamfetamine is also used in adults to treat binge eating disorder (an eating disorder characterized by periods of uncontrolled overeating). Lisdexamfetamine 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: 65162-0028-09Last Updated: 04/28/2024
MedLinePlus Full Drug Details: Lisdexamfetamine
Product Information
| NDC | 65162-0028 |
|---|---|
| Product ID | 65162-028_50798664-15e7-48d2-9f25-353db5e7fb47 |
| Associated GPIs | |
| GCN Sequence Number | 062285 |
| GCN Sequence Number Description | lisdexamfetamine dimesylate CAPSULE 70 MG ORAL |
| HIC3 | J5B |
| HIC3 Description | ADRENERGICS, AROMATIC, NON-CATECHOLAMINE |
| GCN | 98073 |
| HICL Sequence Number | 034486 |
| HICL Sequence Number Description | LISDEXAMFETAMINE DIMESYLATE |
| Brand/Generic | Generic |
| Proprietary Name | Lisdexamfetamine Dimesylate |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Lisdexamfetamine |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | CAPSULE |
| Route | ORAL |
| Active Ingredient Strength | 70 |
| Active Ingredient Units | mg/1 |
| Substance Name | LISDEXAMFETAMINE DIMESYLATE |
| Labeler Name | Amneal Pharmaceuticals LLC |
| Pharmaceutical Class | Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE] |
| DEA Schedule | CII |
| Marketing Category | ANDA |
| Application Number | ANDA202830 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 65162-0028-09 (65162002809)
| NDC Package Code | 65162-028-09 |
|---|---|
| Billing NDC | 65162002809 |
| Package | 90 CAPSULE in 1 BOTTLE (65162-028-09) |
| Marketing Start Date | 2023-08-28 |
| NDC Exclude Flag | N |
| Pricing Information | |
| Price Per Unit | 6.20381 |
| Pricing Unit | EA |
| Effective Date | 2024-02-21 |
| NDC Description | LISDEXAMFETAMINE 70 MG CAPSULE |
| Pharmacy Type Indicator | C/I |
| OTC | N |
| Explanation Code | 1 |
| Classification for Rate Setting | G |
| As of Date | 2024-02-21 |