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NDC 63629-2178-01 Dexmethylphenidate Hydrochloride 5 mg/1 Details
Dexmethylphenidate Hydrochloride 5 mg/1
Dexmethylphenidate Hydrochloride is a ORAL CAPSULE, EXTENDED RELEASE in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Bryant Ranch Prepack. 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: 63629-2178-01Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Dexmethylphenidate
Product Information
| NDC | 63629-2178 |
|---|---|
| Product ID | 63629-2178_927f6044-70f9-4cf0-b1aa-294112b95165 |
| Associated GPIs | 61400016107020 |
| GCN Sequence Number | 059190 |
| GCN Sequence Number Description | dexmethylphenidate HCl CPBP 50-50 5 MG ORAL |
| HIC3 | H2V |
| HIC3 Description | TX FOR ATTENTION DEFICIT-HYPERACT(ADHD)/NARCOLEPSY |
| GCN | 24733 |
| 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 | CAPSULE, EXTENDED RELEASE |
| Route | ORAL |
| Active Ingredient Strength | 5 |
| Active Ingredient Units | mg/1 |
| Substance Name | DEXMETHYLPHENIDATE HYDROCHLORIDE |
| Labeler Name | Bryant Ranch Prepack |
| Pharmaceutical Class | Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE] |
| DEA Schedule | CII |
| Marketing Category | ANDA |
| Application Number | ANDA202842 |
| Listing Certified Through | 2025-12-31 |
Package
NDC 63629-2178-01 (63629217801)
| NDC Package Code | 63629-2178-1 |
|---|---|
| Billing NDC | 63629217801 |
| Package | 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (63629-2178-1) |
| Marketing Start Date | 2021-12-22 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |