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United States · US · US:45963-305_efcdbc4d-7174-4356-9aa2-d557735e2048

dextroamphetamine sulfate

Orange BookUNIISPLATC N06BA02

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

Identification

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

Packs · 1

  • ndc11
    4596330509
    90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (45963-305-09)

Annotations

UNII (FDA Substance ID)
JJ768O327N
DEXTROAMPHETAMINE SULFATE
RxCUI 3287
Orange Book
A203901
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": "45963-305_efcdbc4d-7174-4356-9aa2-d557735e2048",
  "productndc": "45963-305",
  "dosage_form": "CAPSULE, EXTENDED RELEASE",
  "orange_book": {
    "appl_no": "203901",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "5MG",
        "product_no": "001",
        "approval_date": "Nov 30, 2012"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "10MG",
        "product_no": "002",
        "approval_date": "Nov 30, 2012"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "15MG",
        "product_no": "003",
        "approval_date": "Nov 30, 2012"
      }
    ],
    "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": "ANDA203901",
  "marketing_category": "ANDA",
  "nonproprietary_name": "dextroamphetamine sulfate",
  "start_marketing_date": "20140619",
  "active_numerator_strength": "15"
}

Related drugs

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