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NDC 65038-0286-99 AZSTARYS 5.2; 26.1 mg/1; mg/1 Details
AZSTARYS 5.2; 26.1 mg/1; mg/1
AZSTARYS is a ORAL CAPSULE in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Corium, LLC.. The primary component is DEXMETHYLPHENIDATE HYDROCHLORIDE; SERDEXMETHYLPHENIDATE CHLORIDE.
MedlinePlus Drug Summary
The combination of serdexmethylphenidate and 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 6 years of age and older. The combination of serdexmethylphenidate and dexmethylphenidate is in a class of medications called central nervous system stimulants. These medications work by changing the amounts of certain natural substances in the brain.
Related Packages: 65038-0286-99Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Serdexmethylphenidate and Dexmethylphenidate
Product Information
| NDC | 65038-0286 |
|---|---|
| Product ID | 65038-286_bb5e8b93-0bd6-48fa-b9c5-80b76a200cbe |
| Associated GPIs | 61409802800120 |
| GCN Sequence Number | 082022 |
| GCN Sequence Number Description | serdexmethylphen/dexmethylphen CAPSULE 26.1-5.2MG ORAL |
| HIC3 | H2V |
| HIC3 Description | TX FOR ATTENTION DEFICIT-HYPERACT(ADHD)/NARCOLEPSY |
| GCN | 49319 |
| HICL Sequence Number | 047187 |
| HICL Sequence Number Description | SERDEXMETHYLPHENIDATE CHLORIDE/DEXMETHYLPHENIDATE HCL |
| Brand/Generic | Brand |
| Proprietary Name | AZSTARYS |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Serdexmethylphenidate and Dexmethylphenidate |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | CAPSULE |
| Route | ORAL |
| Active Ingredient Strength | 5.2; 26.1 |
| Active Ingredient Units | mg/1; mg/1 |
| Substance Name | DEXMETHYLPHENIDATE HYDROCHLORIDE; SERDEXMETHYLPHENIDATE CHLORIDE |
| Labeler Name | Corium, LLC. |
| Pharmaceutical Class | Central Nervous System Stimulant [EPC], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Central Nervous System Stimulation [PE] |
| DEA Schedule | CII |
| Marketing Category | NDA |
| Application Number | NDA212994 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 65038-0286-99 (65038028699)
| NDC Package Code | 65038-286-99 |
|---|---|
| Billing NDC | 65038028699 |
| Package | 100 CAPSULE in 1 BOTTLE, PLASTIC (65038-286-99) |
| Marketing Start Date | 2021-07-16 |
| NDC Exclude Flag | N |
| Pricing Information | |
| Price Per Unit | 13.3276 |
| Pricing Unit | EA |
| Effective Date | 2024-01-01 |
| NDC Description | AZSTARYS 26.1 MG-5.2 MG CAP |
| Pharmacy Type Indicator | C/I |
| OTC | N |
| Explanation Code | 4 |
| Classification for Rate Setting | B |
| As of Date | 2024-02-21 |