azstarys

Generic: serdexmethylphenidate and dexmethylphenidate

Labeler: corium, llc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name azstarys
Generic Name serdexmethylphenidate and dexmethylphenidate
Labeler corium, llc.
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

dexmethylphenidate hydrochloride 10.4 mg/1, serdexmethylphenidate chloride 52.3 mg/1

Manufacturer
Corium, LLC.

Identifiers & Regulatory

Product NDC 65038-561
Product ID 65038-561_cab174ea-4e48-462d-95a2-fb975f3205a1
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA212994
DEA Schedule cii
Listing Expiration 2026-12-31
Marketing Start 2021-07-16

Pharmacologic Class

Classes
central nervous system stimulant [epc] central nervous system stimulation [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 65038561
Hyphenated Format 65038-561

Supplemental Identifiers

RxCUI
2562186 2562187 2562191 2562194 2562199 2562204
UPC
0365038561993 0365038429996 0365038286995
UNII
FN54BT298Y 1678OK0E08

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name azstarys (source: ndc)
Generic Name serdexmethylphenidate and dexmethylphenidate (source: ndc)
Application Number NDA212994 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10.4 mg/1
  • 52.3 mg/1
source: ndc
Packaging
  • 100 CAPSULE in 1 BOTTLE, PLASTIC (65038-561-99)
source: ndc

Packages (1)

65038-561-99 100 CAPSULE in 1 BOTTLE, PLASTIC (65038-561-99)

Ingredients (2)

dexmethylphenidate hydrochloride (10.4 mg/1) serdexmethylphenidate chloride (52.3 mg/1)

Linked Drug Pages (1)

AZSTARYS ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "cab174ea-4e48-462d-95a2-fb975f3205a1", "openfda": {"upc": ["0365038561993", "0365038429996", "0365038286995"], "unii": ["FN54BT298Y", "1678OK0E08"], "rxcui": ["2562186", "2562187", "2562191", "2562194", "2562199", "2562204"], "spl_set_id": ["00b5e716-5564-4bbd-acaf-df2bc45a5663"], "manufacturer_name": ["Corium, LLC."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE in 1 BOTTLE, PLASTIC (65038-561-99)", "package_ndc": "65038-561-99", "marketing_start_date": "20210716"}], "brand_name": "AZSTARYS", "product_id": "65038-561_cab174ea-4e48-462d-95a2-fb975f3205a1", "dosage_form": "CAPSULE", "pharm_class": ["Central Nervous System Stimulant [EPC]", "Central Nervous System Stimulant [EPC]", "Central Nervous System Stimulation [PE]", "Central Nervous System Stimulation [PE]"], "product_ndc": "65038-561", "dea_schedule": "CII", "generic_name": "Serdexmethylphenidate and Dexmethylphenidate", "labeler_name": "Corium, LLC.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "AZSTARYS", "active_ingredients": [{"name": "DEXMETHYLPHENIDATE HYDROCHLORIDE", "strength": "10.4 mg/1"}, {"name": "SERDEXMETHYLPHENIDATE CHLORIDE", "strength": "52.3 mg/1"}], "application_number": "NDA212994", "marketing_category": "NDA", "marketing_start_date": "20210716", "listing_expiration_date": "20261231"}