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NDC 57664-0378-13 Dexmethylphenidate hydrochloride 5 mg/1 Details
Dexmethylphenidate hydrochloride 5 mg/1
Dexmethylphenidate hydrochloride is a ORAL TABLET in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Sun Pharmaceutical Industries, Inc.. The primary component is DEXMETHYLPHENIDATE HYDROCHLORIDE.
MedlinePlus Drug Summary
Dexmethylphenidate 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. Dexmethylphenidate is in a class of medications called central nervous system (CNS) stimulants. It works by increasing the amounts of certain natural substances in the brain.
Related Packages: 57664-0378-13Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Dexmethylphenidate
Product Information
| NDC | 57664-0378 |
|---|---|
| Product ID | 57664-378_0d0cbfc3-ae27-b481-e063-6394a90a917c |
| Associated GPIs | 61400016100330 |
| GCN Sequence Number | 048983 |
| GCN Sequence Number Description | dexmethylphenidate HCl TABLET 5 MG ORAL |
| HIC3 | H2V |
| HIC3 Description | TX FOR ATTENTION DEFICIT-HYPERACT(ADHD)/NARCOLEPSY |
| GCN | 14974 |
| HICL Sequence Number | 022987 |
| HICL Sequence Number Description | DEXMETHYLPHENIDATE HCL |
| Brand/Generic | Generic |
| Proprietary Name | Dexmethylphenidate hydrochloride |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Dexmethylphenidate hydrochloride |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | TABLET |
| Route | ORAL |
| Active Ingredient Strength | 5 |
| Active Ingredient Units | mg/1 |
| Substance Name | DEXMETHYLPHENIDATE HYDROCHLORIDE |
| 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 | ANDA201231 |
| Listing Certified Through | 2025-12-31 |
Package
NDC 57664-0378-13 (57664037813)
| NDC Package Code | 57664-378-13 |
|---|---|
| Billing NDC | 57664037813 |
| Package | 500 TABLET in 1 BOTTLE (57664-378-13) |
| Marketing Start Date | 2013-09-26 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |