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United States · US · US:24478-102_32c90701-fe4a-4d5a-b3bb-e9ccf0416ece
Dyanavel XR
In shortageOrange BookUNIISPLATC N06BA01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerNextWave Pharmaceuticals, Inc
CountryUS (United States)
ATC codeN06BA01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc1124478102011 BOTTLE in 1 CARTON (24478-102-01) / 464 mL in 1 BOTTLE
- ndc1124478102021 BOTTLE in 1 CARTON (24478-102-02) / 60 mL in 1 BOTTLE
Annotations
UNII (FDA Substance ID)
CK833KGX7E
AMPHETAMINE
RxCUI 725
Orange Book
N208147
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Amphetamine Aspartate Monohydrate, Amphetamine Sulfate, Dextroamphetamine Saccharate, Dextroamphetamine Sulfate Tablet
Raw payload (JSON)
{
"unii": {
"unii": "CK833KGX7E",
"rxcui": "725",
"inchikey": "KWTSXDURSIMDCE-UHFFFAOYSA-N",
"display_name": "AMPHETAMINE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"ae304b29-0b40-40ec-ad0d-76b742d4a9b9": {
"match": "brand_token",
"title": "DYANAVEL XR (AMPHETAMINE) SUSPENSION, EXTENDED RELEASE DYANAVEL XR (AMPHETAMINE) TABLET, EXTENDED RELEASE [NEXTWAVE PHARMACEUTICALS, INC]",
"spl_version": "14",
"published_date": "2026-02-26"
}
},
"productid": "24478-102_32c90701-fe4a-4d5a-b3bb-e9ccf0416ece",
"productndc": "24478-102",
"dosage_form": "SUSPENSION, EXTENDED RELEASE",
"orange_book": {
"appl_no": "208147",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "2MG/ML;EQ 0.5MG BASE/ML",
"product_no": "001",
"approval_date": "Oct 19, 2015"
}
],
"appl_type": "N"
},
"dea_schedule": "CII",
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "AMPHETAMINE",
"shortage_reason": "Amphetamine Aspartate Monohydrate, Amphetamine Sulfate, Dextroamphetamine Saccharate, Dextroamphetamine Sulfate Tablet",
"shortage_status": "current",
"proprietary_name": "Dyanavel XR",
"active_ingred_unit": "mg/mL",
"application_number": "NDA208147",
"marketing_category": "NDA",
"nonproprietary_name": "amphetamine",
"start_marketing_date": "20151001",
"active_numerator_strength": "2.5"
}Related drugs
Other records sharing ATC code N06BA01.
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