Hydrocodone Bitartrate and Acetaminophen

{
  "unii": {
    "unii": "362O9ITL9D",
    "rxcui": "161",
    "inchikey": "RZVAJINKPMORJF-UHFFFAOYSA-N",
    "display_name": "ACETAMINOPHEN",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "1f9c1adc-f84f-43de-af5c-d93703aba7f8": {
      "match": "brand_token",
      "title": "HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [RHODES PHARMACEUTICALS LLC]",
      "spl_version": "20",
      "published_date": "2026-06-01"
    }
  },
  "productid": "13107-211_265ff2e7-c060-4a82-909b-26e71c262dd6",
  "productndc": "13107-211",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "207709",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AA",
        "strength": "300MG;5MG",
        "product_no": "001",
        "approval_date": "Sep 13, 2018"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AA",
        "strength": "300MG;7.5MG",
        "product_no": "002",
        "approval_date": "Sep 13, 2018"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AA",
        "strength": "300MG;10MG",
        "product_no": "003",
        "approval_date": "Sep 13, 2018"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": "CII",
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ACETAMINOPHEN; HYDROCODONE BITARTRATE",
  "shortage_reason": "Acetaminophen; Oxycodone Hydrochloride Tablet",
  "shortage_status": "current",
  "proprietary_name": "Hydrocodone Bitartrate and Acetaminophen",
  "active_ingred_unit": "mg/1; mg/1",
  "application_number": "ANDA207709",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Hydrocodone Bitartrate and Acetaminophen",
  "start_marketing_date": "20150506",
  "active_numerator_strength": "300; 5"
}