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United States · US · US:0115-9927_42b19d09-cffd-4772-bc84-76c2066d6f00

Dextroamphetamine Sulfate

Orange BookUNIISPLATC N06BA02

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

Identification

ManufacturerAmneal Pharmaceuticals of New York LLC
CountryUS (United States)
ATC codeN06BA02
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    0115992710
    90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0115-9927-10)

Annotations

UNII (FDA Substance ID)
JJ768O327N
DEXTROAMPHETAMINE SULFATE
RxCUI 3287
Orange Book
N017078
ABABAB
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": "0115-9927_42b19d09-cffd-4772-bc84-76c2066d6f00",
  "productndc": "0115-9927",
  "dosage_form": "CAPSULE, EXTENDED RELEASE",
  "orange_book": {
    "appl_no": "017078",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "5MG",
        "product_no": "001",
        "approval_date": "Approved Prior to Jan 1, 1982"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "10MG",
        "product_no": "002",
        "approval_date": "Approved Prior to Jan 1, 1982"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "15MG",
        "product_no": "003",
        "approval_date": "Approved Prior to Jan 1, 1982"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": "CII",
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "DEXTROAMPHETAMINE SULFATE",
  "proprietary_name": "Dextroamphetamine Sulfate",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA017078",
  "marketing_category": "NDA AUTHORIZED GENERIC",
  "nonproprietary_name": "Dextroamphetamine Sulfate",
  "start_marketing_date": "19760802",
  "active_numerator_strength": "5"
}

Related drugs

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