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NDC 57664-0086-88 LISDEXAMFETAMINE DIMESYLATE 40 mg/1 Details
LISDEXAMFETAMINE DIMESYLATE 40 mg/1
LISDEXAMFETAMINE DIMESYLATE is a ORAL TABLET, CHEWABLE in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Sun Pharmaceutical Industries, Inc.. 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: 57664-0086-88Last Updated: 04/21/2024
MedLinePlus Full Drug Details: Lisdexamfetamine
Product Information
| NDC | 57664-0086 |
|---|---|
| Product ID | 57664-086_0b77417a-5789-8818-e063-6294a90ad2e3 |
| Associated GPIs | |
| GCN Sequence Number | 077144 |
| GCN Sequence Number Description | lisdexamfetamine dimesylate TAB CHEW 40 MG ORAL |
| HIC3 | J5B |
| HIC3 Description | ADRENERGICS, AROMATIC, NON-CATECHOLAMINE |
| GCN | 43063 |
| 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 DIMESYLATE |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | TABLET, CHEWABLE |
| Route | ORAL |
| Active Ingredient Strength | 40 |
| Active Ingredient Units | mg/1 |
| Substance Name | LISDEXAMFETAMINE DIMESYLATE |
| Labeler Name | Sun Pharmaceutical Industries, Inc. |
| Pharmaceutical Class | Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE] |
| DEA Schedule | CII |
| Marketing Category | ANDA |
| Application Number | ANDA214134 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 57664-0086-88 (57664008688)
| NDC Package Code | 57664-086-88 |
|---|---|
| Billing NDC | 57664008688 |
| Package | 100 TABLET, CHEWABLE in 1 BOTTLE (57664-086-88) |
| Marketing Start Date | 2023-08-25 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |