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United States · US · US:11584-0030_18834fb3-9eae-0e94-e063-6394a90accfb

Tencon

In shortageOrange BookUNIISPLATC N02BE

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

Identification

ManufacturerEl Dorado Distributors LLC
CountryUS (United States)
ATC codeN02BE
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    1158400301
    100 TABLET in 1 BOTTLE, PLASTIC (11584-0030-1)

Annotations

UNII (FDA Substance ID)
362O9ITL9D
ACETAMINOPHEN
RxCUI 161
Orange Book
A089987
AA
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Acetaminophen; Oxycodone Hydrochloride Tablet
Raw payload (JSON)
{
  "unii": {
    "unii": "362O9ITL9D",
    "rxcui": "161",
    "inchikey": "RZVAJINKPMORJF-UHFFFAOYSA-N",
    "display_name": "ACETAMINOPHEN",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "4e4a9925-67aa-4be7-8bb7-c8b058ffe223": {
      "match": "brand_token",
      "title": "TENCON (BUTALBITAL AND ACETAMINOPHEN) TABLET [EL DORADO DISTRIBUTORS LLC]",
      "spl_version": "6",
      "published_date": "2024-05-17"
    }
  },
  "productid": "11584-0030_18834fb3-9eae-0e94-e063-6394a90accfb",
  "productndc": "11584-0030",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "089987",
    "products": [
      {
        "rs": true,
        "rld": false,
        "te_code": "AA",
        "strength": "325MG;50MG",
        "product_no": "001",
        "approval_date": "Oct 26, 1992"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ACETAMINOPHEN; BUTALBITAL",
  "shortage_reason": "Acetaminophen; Oxycodone Hydrochloride Tablet",
  "shortage_status": "current",
  "proprietary_name": "Tencon",
  "active_ingred_unit": "mg/1; mg/1",
  "application_number": "ANDA089987",
  "marketing_category": "ANDA",
  "nonproprietary_name": "butalbital and acetaminophen",
  "start_marketing_date": "20131010",
  "active_numerator_strength": "325; 50"
}

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