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NDC 68968-0205-03 XELSTRYM 4.5 mg/1 Details
XELSTRYM 4.5 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 | 68968-0205 |
|---|---|
| Product ID | 68968-0205_e5900a68-2bd4-4c69-9caf-131164062979 |
| Associated GPIs | |
| GCN Sequence Number | 083233 |
| GCN Sequence Number Description | dextroamphetamine PATCH TD24 4.5 MG/9HR TRANSDERM |
| HIC3 | J5B |
| HIC3 Description | ADRENERGICS, AROMATIC, NON-CATECHOLAMINE |
| GCN | 52134 |
| 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 | 4.5 |
| 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 68968-0205-03 (68968020503)
| NDC Package Code | 68968-0205-3 |
|---|---|
| Billing NDC | 68968020503 |
| Package | 30 POUCH in 1 CARTON (68968-0205-3) / 1 PATCH, EXTENDED RELEASE in 1 POUCH (68968-0205-1) |
| Marketing Start Date | 2023-05-15 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |