Adzenys XR-ODT

In shortageOrange BookUNIISPLATC N06BA01

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

Identification

ManufacturerNeos Therapeutics Brands, LLC

CountryUS (United States)

ATC codeN06BA01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
7016502030
30 BLISTER PACK in 1 CARTON (70165-020-30) / 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK

Annotations

UNII (FDA Substance ID)

CK833KGX7E

AMPHETAMINE

RxCUI 725

Orange Book

N204326

ABABABABABAB

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": {
    "c1179269-00b5-48ea-972d-31e614e99b7e": {
      "match": "brand_token",
      "title": "ADZENYS XR-ODT (AMPHETAMINE) TABLET, ORALLY DISINTEGRATING [NEOS THERAPEUTICS BRANDS, LLC]",
      "spl_version": "15",
      "published_date": "2026-05-14"
    }
  },
  "productid": "70165-020_512c5af5-6bf8-ace1-e063-6394a90ad807",
  "productndc": "70165-020",
  "dosage_form": "TABLET, ORALLY DISINTEGRATING",
  "orange_book": {
    "appl_no": "204326",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "EQ 3.1MG BASE",
        "product_no": "001",
        "approval_date": "Jan 27, 2016"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "EQ 6.3MG BASE",
        "product_no": "002",
        "approval_date": "Jan 27, 2016"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "EQ 9.4MG BASE",
        "product_no": "003",
        "approval_date": "Jan 27, 2016"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "EQ 12.5MG BASE",
        "product_no": "004",
        "approval_date": "Jan 27, 2016"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "EQ 15.7MG BASE",
        "product_no": "005",
        "approval_date": "Jan 27, 2016"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "EQ 18.8MG BASE",
        "product_no": "006",
        "approval_date": "Jan 27, 2016"
      }
    ],
    "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": "Adzenys XR-ODT",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA204326",
  "marketing_category": "NDA",
  "nonproprietary_name": "Amphetamine",
  "start_marketing_date": "20160216",
  "active_numerator_strength": "12.5"
}

Related drugs

Other records sharing ATC code N06BA01.

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