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United States · US · US:13107-036_a0c002da-f6e9-4979-af9b-5ca20118bc43

DEXTROAMPHETAMINE SULFATE

Orange BookUNIISPLATC N06BA02

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

Identification

ManufacturerAurolife Pharma, LLC
CountryUS (United States)
ATC codeN06BA02
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 3

  • ndc11
    1310703601
    100 TABLET in 1 BOTTLE (13107-036-01)
  • ndc11
    1310703650
    50 TABLET in 1 BOTTLE (13107-036-50)
  • ndc11
    1310703699
    1000 TABLET in 1 BOTTLE (13107-036-99)

Annotations

UNII (FDA Substance ID)
JJ768O327N
DEXTROAMPHETAMINE SULFATE
RxCUI 3287
Orange Book
A202893
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": "13107-036_a0c002da-f6e9-4979-af9b-5ca20118bc43",
  "productndc": "13107-036",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "202893",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AA",
        "strength": "5MG",
        "product_no": "001",
        "approval_date": "Jul 31, 2013"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AA",
        "strength": "10MG",
        "product_no": "002",
        "approval_date": "Jul 31, 2013"
      }
    ],
    "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": "ANDA202893",
  "marketing_category": "ANDA",
  "nonproprietary_name": "DEXTROAMPHETAMINE SULFATE",
  "start_marketing_date": "20130731",
  "active_numerator_strength": "10"
}

Related drugs

Other records sharing ATC code N06BA02.

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