xelstrym

Generic: dextroamphetamine

Labeler: noven therapeutics, llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name xelstrym
Generic Name dextroamphetamine
Labeler noven therapeutics, llc
Dosage Form PATCH, EXTENDED RELEASE
Routes
TRANSDERMAL
Active Ingredients

dextroamphetamine 13.5 mg/1

Manufacturer
Noven Therapeutics, LLC

Identifiers & Regulatory

Product NDC 68968-0215
Product ID 68968-0215_11163145-d173-4320-aac9-92069f0cbf4a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA215401
DEA Schedule cii
Listing Expiration 2026-12-31
Marketing Start 2023-05-15

Pharmacologic Class

Established (EPC)
central nervous system stimulant [epc]
Physiologic Effect
central nervous system stimulation [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 689680215
Hyphenated Format 68968-0215

Supplemental Identifiers

RxCUI
2624701 2624708 2624712 2624715 2624726 2624729 2624732 2624735
UNII
TZ47U051FI
NUI
N0000175739 N0000175729

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 xelstrym (source: ndc)
Generic Name dextroamphetamine (source: ndc)
Application Number NDA215401 (source: ndc)
Routes
TRANSDERMAL
source: ndc

Resolved Composition

Strengths
  • 13.5 mg/1
source: ndc
Packaging
  • 30 POUCH in 1 CARTON (68968-0215-3) / 1 PATCH, EXTENDED RELEASE in 1 POUCH (68968-0215-1)
source: ndc

Packages (1)

68968-0215-3 30 POUCH in 1 CARTON (68968-0215-3) / 1 PATCH, EXTENDED RELEASE in 1 POUCH (68968-0215-1)

Ingredients (1)

dextroamphetamine (13.5 mg/1)

Linked Drug Pages (1)

XELSTRYM ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TRANSDERMAL"], "spl_id": "11163145-d173-4320-aac9-92069f0cbf4a", "openfda": {"nui": ["N0000175739", "N0000175729"], "unii": ["TZ47U051FI"], "rxcui": ["2624701", "2624708", "2624712", "2624715", "2624726", "2624729", "2624732", "2624735"], "spl_set_id": ["0862f02a-72a8-41cc-8845-57cf4974bb6f"], "pharm_class_pe": ["Central Nervous System Stimulation [PE]"], "pharm_class_epc": ["Central Nervous System Stimulant [EPC]"], "manufacturer_name": ["Noven Therapeutics, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 POUCH in 1 CARTON (68968-0215-3)  / 1 PATCH, EXTENDED RELEASE in 1 POUCH (68968-0215-1)", "package_ndc": "68968-0215-3", "marketing_start_date": "20230515"}], "brand_name": "XELSTRYM", "product_id": "68968-0215_11163145-d173-4320-aac9-92069f0cbf4a", "dosage_form": "PATCH, EXTENDED RELEASE", "pharm_class": ["Central Nervous System Stimulant [EPC]", "Central Nervous System Stimulation [PE]"], "product_ndc": "68968-0215", "dea_schedule": "CII", "generic_name": "DEXTROAMPHETAMINE", "labeler_name": "Noven Therapeutics, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "XELSTRYM", "active_ingredients": [{"name": "DEXTROAMPHETAMINE", "strength": "13.5 mg/1"}], "application_number": "NDA215401", "marketing_category": "NDA", "marketing_start_date": "20230515", "listing_expiration_date": "20261231"}