Zenzedi

Orange BookUNIISPLATC N06BA02

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

Identification

ManufacturerAzurity Pharmaceuticals, Inc.

CountryUS (United States)

ATC codeN06BA02

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
2433885303
30 TABLET in 1 BOTTLE (24338-853-03)

Annotations

UNII (FDA Substance ID)

JJ768O327N

DEXTROAMPHETAMINE SULFATE

RxCUI 3287

Orange Book

A090533

AAAAAAAAAAAAAA

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "JJ768O327N",
    "rxcui": "3287",
    "inchikey": "PYHRZPFZZDCOPH-QXGOIDDHSA-N",
    "display_name": "DEXTROAMPHETAMINE SULFATE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "d6394df5-f2c9-47eb-b57e-f3e9cfd94f84": {
      "match": "brand_token",
      "title": "ZENZEDI (DEXTROAMPHETAMINE SULFATE) TABLET [AZURITY PHARMACEUTICALS, INC.]",
      "spl_version": "14",
      "published_date": "2026-01-12"
    }
  },
  "productid": "24338-853_67939d07-156a-4af8-9520-3c0b146aa681",
  "productndc": "24338-853",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "090533",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AA",
        "strength": "2.5MG",
        "product_no": "001",
        "approval_date": "Oct 25, 2011"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AA",
        "strength": "5MG",
        "product_no": "002",
        "approval_date": "Oct 25, 2011"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AA",
        "strength": "7.5MG",
        "product_no": "003",
        "approval_date": "Oct 25, 2011"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AA",
        "strength": "10MG",
        "product_no": "004",
        "approval_date": "Oct 25, 2011"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AA",
        "strength": "15MG",
        "product_no": "005",
        "approval_date": "Oct 25, 2011"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AA",
        "strength": "20MG",
        "product_no": "006",
        "approval_date": "Oct 25, 2011"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AA",
        "strength": "30MG",
        "product_no": "007",
        "approval_date": "Oct 25, 2011"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": "CII",
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "DEXTROAMPHETAMINE SULFATE",
  "proprietary_name": "Zenzedi",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA090533",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Dextroamphetamine Sulfate",
  "start_marketing_date": "20130531",
  "active_numerator_strength": "10"
}

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