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United States · US · US:21724-701_06b4c32e-1880-40e9-9de2-0927cb8c1500

PROCENTRA

Orange BookUNIISPLATC N06BA02

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

Identification

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

Packs · 1

  • ndc11
    2172470105
    473 mL in 1 BOTTLE, PLASTIC (21724-701-05)

Annotations

UNII (FDA Substance ID)
JJ768O327N
DEXTROAMPHETAMINE SULFATE
RxCUI 3287
Orange Book
A040776
AA
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": {
    "1548cce2-fb6b-4f17-8a3b-868933f6c9d6": {
      "match": "brand_token",
      "title": "PROCENTRA (DEXTROAMPHETAMINE SULFATE) SOLUTION [INDEPENDENCE PHARMACEUTICALS, LLC]",
      "spl_version": "17",
      "published_date": "2025-11-17"
    }
  },
  "productid": "21724-701_06b4c32e-1880-40e9-9de2-0927cb8c1500",
  "productndc": "21724-701",
  "dosage_form": "SOLUTION",
  "orange_book": {
    "appl_no": "040776",
    "products": [
      {
        "rs": true,
        "rld": false,
        "te_code": "AA",
        "strength": "5MG/5ML",
        "product_no": "001",
        "approval_date": "Jan 29, 2008"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": "CII",
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "DEXTROAMPHETAMINE SULFATE",
  "proprietary_name": "PROCENTRA",
  "active_ingred_unit": "mg/5mL",
  "application_number": "ANDA040776",
  "marketing_category": "ANDA",
  "nonproprietary_name": "dextroamphetamine sulfate",
  "start_marketing_date": "20140515",
  "active_numerator_strength": "5"
}

Related drugs

Other records sharing ATC code N06BA02.

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