DYANAVEL XR

In shortageOrange BookUNIISPLATC N06BA01

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerNextWave Pharmaceuticals, Inc

CountryUS (United States)

ATC codeN06BA01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
2447810901
30 TABLET, EXTENDED RELEASE in 1 BOTTLE (24478-109-01)

Annotations

UNII (FDA Substance ID)

CK833KGX7E

AMPHETAMINE

RxCUI 725

Orange Book

N210526

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": "24478-109_32c90701-fe4a-4d5a-b3bb-e9ccf0416ece",
  "productndc": "24478-109",
  "dosage_form": "TABLET, EXTENDED RELEASE",
  "orange_book": {
    "appl_no": "210526",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "4MG;EQ 1MG BASE",
        "product_no": "001",
        "approval_date": "Nov 4, 2021"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "8MG;EQ 2MG BASE",
        "product_no": "002",
        "approval_date": "Nov 4, 2021"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "12MG;EQ 3MG BASE",
        "product_no": "003",
        "approval_date": "Nov 4, 2021"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "16MG;EQ 4MG BASE",
        "product_no": "004",
        "approval_date": "Nov 4, 2021"
      }
    ],
    "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/1",
  "application_number": "NDA210526",
  "marketing_category": "NDA",
  "nonproprietary_name": "amphetamine",
  "start_marketing_date": "20211104",
  "active_numerator_strength": "15"
}

Related drugs

Other records sharing ATC code N06BA01.

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