Promethazine Hydrochloride and Dextromethorphan Hydrobromide

{
  "unii": {
    "unii": "9D2RTI9KYH",
    "rxcui": "102490",
    "inchikey": "STTADZBLEUMJRG-IKNOHUQMSA-N",
    "display_name": "DEXTROMETHORPHAN HYDROBROMIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "b0ba50da-9f70-4531-a9de-3dd3f8aa1f5d": {
      "match": "brand_token",
      "title": "PROMETHAZINE HYDROCHLORIDE TABLET [PD-RX PHARMACEUTICALS, INC.]",
      "spl_version": "19",
      "published_date": "2026-05-25"
    }
  },
  "productid": "76420-335_348f2d59-90ce-1534-e063-6294a90a960a",
  "productndc": "76420-335",
  "dosage_form": "SOLUTION",
  "orange_book": {
    "appl_no": "011265",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": "AA",
        "strength": "15MG/5ML;6.25MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",
        "product_no": "002",
        "approval_date": "Apr 2, 1984"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "DEXTROMETHORPHAN HYDROBROMIDE; PROMETHAZINE HYDROCHLORIDE",
  "proprietary_name": "Promethazine Hydrochloride and Dextromethorphan Hydrobromide",
  "active_ingred_unit": "mg/5mL; mg/5mL",
  "application_number": "NDA011265",
  "marketing_category": "NDA AUTHORIZED GENERIC",
  "nonproprietary_name": "Promethazine Hydrochloride and Dextromethorphan Hydrobromide",
  "start_marketing_date": "20240905",
  "active_numerator_strength": "15; 6.25"
}