Back to search
🇺🇸

United States · US · US:24338-019_ac355447-df74-4bb1-b0b6-1869a4846309

ARYNTA

In shortageOrange BookUNIISPLATC N06BA

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerAzurity Pharmaceuticals, Inc.
CountryUS (United States)
ATC codeN06BA
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    2433801901
    1 BOTTLE in 1 CARTON (24338-019-01) / 100 mL in 1 BOTTLE

Annotations

UNII (FDA Substance ID)
SJT761GEGS
LISDEXAMFETAMINE DIMESYLATE
RxCUI 673579
Orange Book
N219847
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Lisdexamfetamine Dimesylate Tablet, Chewable
Raw payload (JSON)
{
  "unii": {
    "unii": "SJT761GEGS",
    "rxcui": "673579",
    "inchikey": "CETWSOHVEGTIBR-FORAGAHYSA-N",
    "display_name": "LISDEXAMFETAMINE DIMESYLATE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "71cdfc97-96af-4378-a44a-6d5d77e7d6b7": {
      "match": "brand_token",
      "title": "ARYNTA (LISDEXAMFETAMINE DIMESYLATE ORAL) SOLUTION [AZURITY PHARMACEUTICALS, INC.]",
      "spl_version": "4",
      "published_date": "2026-03-20"
    }
  },
  "productid": "24338-019_ac355447-df74-4bb1-b0b6-1869a4846309",
  "productndc": "24338-019",
  "dosage_form": "SOLUTION",
  "orange_book": {
    "appl_no": "219847",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "10MG/ML",
        "product_no": "001",
        "approval_date": "Jun 16, 2025"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": "CII",
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "LISDEXAMFETAMINE DIMESYLATE",
  "shortage_reason": "Lisdexamfetamine Dimesylate Tablet, Chewable",
  "shortage_status": "current",
  "proprietary_name": "ARYNTA",
  "active_ingred_unit": "mg/mL",
  "application_number": "NDA219847",
  "marketing_category": "NDA",
  "nonproprietary_name": "lisdexamfetamine dimesylate oral",
  "start_marketing_date": "20260320",
  "active_numerator_strength": "10"
}

Related drugs

Other records sharing ATC code N06BA.

Access this data programmatically

Query ARYNTA and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.