{
  "meta": {
    "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.",
    "terms": "https://open.fda.gov/terms/",
    "license": "https://open.fda.gov/license/",
    "last_updated": "2026-09-03",
    "results": {
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    {
      "update_type": "Reverified",
      "initial_posting_date": "11/21/2023",
      "package_ndc": "0641-1495-35",
      "generic_name": "Promethazine Hydrochloride Injection",
      "contact_info": "800-631-2174",
      "availability": "Available",
      "related_info": "Additional lots are scheduled to be manufactured. Product will be made available as it is released.",
      "openfda": {
        "application_number": [
          "ANDA083312"
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        "brand_name": [
          "PROMETHAZINE HYDROCHLORIDE"
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        "generic_name": [
          "PROMETHAZINE HYDROCHLORIDE"
        ],
        "manufacturer_name": [
          "Hikma Pharmaceuticals USA Inc."
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        "product_ndc": [
          "0641-1495",
          "0641-1496"
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        "product_type": [
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        "route": [
          "INTRAMUSCULAR",
          "INTRAVENOUS"
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        "substance_name": [
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          "0641-1495-35",
          "0641-1496-31",
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        "unii": [
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      "update_date": "08/13/2026",
      "therapeutic_category": [
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        "Gastroenterology",
        "Pediatric",
        "Pulmonary/Allergy"
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      "dosage_form": "Injection",
      "presentation": "Promethazine Hydrochloride, Injection, 25 mg/1 mL (NDC 0641-1495-35)",
      "company_name": "Hikma Pharmaceuticals USA, Inc.",
      "status": "Current"
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  ]
}