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NDC 50458-0586-01 CONCERTA 36 mg/1 Details
CONCERTA 36 mg/1
CONCERTA is a ORAL TABLET, EXTENDED RELEASE in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Janssen Pharmaceuticals, Inc.. The primary component is METHYLPHENIDATE HYDROCHLORIDE.
MedlinePlus Drug Summary
Methylphenidate 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. Methylphenidate (Methylin) is also used to treat narcolepsy (a sleep disorder that causes excessive daytime sleepiness and sudden attacks of sleep). Methylphenidate is in a class of medications called central nervous system (CNS) stimulants. It works by changing the amounts of certain natural substances in the brain.
Related Packages: 50458-0586-01Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Methylphenidate
Product Information
| NDC | 50458-0586 |
|---|---|
| Product ID | 50458-586_08b98ac0-d816-ef9b-e063-6394a90a2192 |
| Associated GPIs | 61400020100470 |
| GCN Sequence Number | 045982 |
| GCN Sequence Number Description | methylphenidate HCl TAB ER 24 36 MG ORAL |
| HIC3 | H2V |
| HIC3 Description | TX FOR ATTENTION DEFICIT-HYPERACT(ADHD)/NARCOLEPSY |
| GCN | 12568 |
| HICL Sequence Number | 001682 |
| HICL Sequence Number Description | METHYLPHENIDATE HCL |
| Brand/Generic | Brand |
| Proprietary Name | CONCERTA |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Methylphenidate hydrochloride |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | TABLET, EXTENDED RELEASE |
| Route | ORAL |
| Active Ingredient Strength | 36 |
| Active Ingredient Units | mg/1 |
| Substance Name | METHYLPHENIDATE HYDROCHLORIDE |
| Labeler Name | Janssen Pharmaceuticals, Inc. |
| Pharmaceutical Class | Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE] |
| DEA Schedule | CII |
| Marketing Category | NDA |
| Application Number | NDA021121 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 50458-0586-01 (50458058601)
| NDC Package Code | 50458-586-01 |
|---|---|
| Billing NDC | 50458058601 |
| Package | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (50458-586-01) |
| Marketing Start Date | 2000-08-01 |
| NDC Exclude Flag | N |
| Pricing Information | |
| Price Per Unit | 13.053 |
| Pricing Unit | EA |
| Effective Date | 2023-11-22 |
| NDC Description | CONCERTA ER 36 MG TABLET |
| Pharmacy Type Indicator | C/I |
| OTC | N |
| Explanation Code | 2 |
| Classification for Rate Setting | B |
| As of Date | 2024-02-21 |