Dextroamphetamine Sulfate

Orange BookUNIISPLATC N06BA02

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

Identification

ManufacturerTeva Pharmaceuticals USA, Inc.

CountryUS (United States)

ATC codeN06BA02

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
0555095302
100 TABLET in 1 BOTTLE (0555-0953-02)

Annotations

UNII (FDA Substance ID)

JJ768O327N

DEXTROAMPHETAMINE SULFATE

RxCUI 3287

Orange Book

A040361

AAAA

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": {
    "f6dfefdf-7a4a-e104-e053-6394a90a05bd": {
      "match": "brand_token",
      "title": "DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE (DEXTROAMPHETAMINE SULFATE, DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE SULFATE AND AMPHETAMINE ASPARTATE) CAPSULE, EXTENDED RELEASE [GOLDEN STATE MEDICAL SUPPLY, INC.]",
      "spl_version": "7",
      "published_date": "2026-06-01"
    }
  },
  "productid": "0555-0953_05934bca-3ed9-4ce3-ba1d-2063930aad63",
  "productndc": "0555-0953",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "040361",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AA",
        "strength": "5MG",
        "product_no": "001",
        "approval_date": "Jan 31, 2001"
      },
      {
        "rs": true,
        "rld": false,
        "te_code": "AA",
        "strength": "10MG",
        "product_no": "002",
        "approval_date": "Jan 31, 2001"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": "CII",
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "DEXTROAMPHETAMINE SULFATE",
  "proprietary_name": "Dextroamphetamine Sulfate",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA040361",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Dextroamphetamine Sulfate",
  "start_marketing_date": "20010212",
  "active_numerator_strength": "10"
}

Related drugs

Other records sharing ATC code N06BA02.

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