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NDC 68968-0220-03 XELSTRYM 18 mg/1 Details
XELSTRYM 18 mg/1
XELSTRYM is a TRANSDERMAL PATCH, EXTENDED RELEASE in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Noven Therapeutics, LLC. The primary component is DEXTROAMPHETAMINE.
Product Information
NDC | 68968-0220 |
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Product ID | 68968-0220_e5900a68-2bd4-4c69-9caf-131164062979 |
Associated GPIs | |
GCN Sequence Number | 083232 |
GCN Sequence Number Description | dextroamphetamine PATCH TD24 18 MG/9 HR TRANSDERM |
HIC3 | J5B |
HIC3 Description | ADRENERGICS, AROMATIC, NON-CATECHOLAMINE |
GCN | 52133 |
HICL Sequence Number | 047926 |
HICL Sequence Number Description | DEXTROAMPHETAMINE |
Brand/Generic | Brand |
Proprietary Name | XELSTRYM |
Proprietary Name Suffix | n/a |
Non-Proprietary Name | DEXTROAMPHETAMINE |
Product Type | HUMAN PRESCRIPTION DRUG |
Dosage Form | PATCH, EXTENDED RELEASE |
Route | TRANSDERMAL |
Active Ingredient Strength | 18 |
Active Ingredient Units | mg/1 |
Substance Name | DEXTROAMPHETAMINE |
Labeler Name | Noven Therapeutics, LLC |
Pharmaceutical Class | Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE] |
DEA Schedule | CII |
Marketing Category | NDA |
Application Number | NDA215401 |
Listing Certified Through | 2024-12-31 |
Package
NDC 68968-0220-03 (68968022003)
NDC Package Code | 68968-0220-3 |
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Billing NDC | 68968022003 |
Package | 30 POUCH in 1 CARTON (68968-0220-3) / 1 PATCH, EXTENDED RELEASE in 1 POUCH (68968-0220-1) |
Marketing Start Date | 2023-05-15 |
NDC Exclude Flag | N |
Pricing Information | N/A |