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NDC 71376-0204-03 JORNAY PM 80 mg/1 Details
JORNAY PM 80 mg/1
JORNAY PM is a ORAL CAPSULE in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Ironshore 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: 71376-0204-03Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Methylphenidate
Product Information
| NDC | 71376-0204 |
|---|---|
| Product ID | 71376-204_73f8eb7c-c51f-45f5-97eb-5b72418d300b |
| Associated GPIs | 61400020107090 |
| GCN Sequence Number | 078727 |
| GCN Sequence Number Description | methylphenidate HCl CPDR ER SP 80 MG ORAL |
| HIC3 | H2V |
| HIC3 Description | TX FOR ATTENTION DEFICIT-HYPERACT(ADHD)/NARCOLEPSY |
| GCN | 45109 |
| HICL Sequence Number | 001682 |
| HICL Sequence Number Description | METHYLPHENIDATE HCL |
| Brand/Generic | Brand |
| Proprietary Name | JORNAY PM |
| Proprietary Name Suffix | Extended-Release |
| Non-Proprietary Name | Methylphenidate Hydrochloride |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | CAPSULE |
| Route | ORAL |
| Active Ingredient Strength | 80 |
| Active Ingredient Units | mg/1 |
| Substance Name | METHYLPHENIDATE HYDROCHLORIDE |
| Labeler Name | Ironshore Pharmaceuticals Inc. |
| Pharmaceutical Class | Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE] |
| DEA Schedule | CII |
| Marketing Category | NDA |
| Application Number | NDA209311 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 71376-0204-03 (71376020403)
| NDC Package Code | 71376-204-03 |
|---|---|
| Billing NDC | 71376020403 |
| Package | 100 CAPSULE in 1 BOTTLE (71376-204-03) |
| Marketing Start Date | 2019-06-01 |
| NDC Exclude Flag | N |
| Pricing Information | |
| Price Per Unit | 14.5359 |
| Pricing Unit | EA |
| Effective Date | 2024-01-12 |
| NDC Description | JORNAY PM 80 MG CAPSULE |
| Pharmacy Type Indicator | C/I |
| OTC | N |
| Explanation Code | 4 |
| Classification for Rate Setting | B |
| As of Date | 2024-02-21 |