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United States · US · US:82804-181_5d9123f6-b322-4fa0-bf48-6335a6adcbb8

Acetaminophen and Codeine Phosphate

In shortageOrange BookUNIISPLATC N02BE

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

Identification

ManufacturerProficient Rx LP
CountryUS (United States)
ATC codeN02BE
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    8280418130
    30 TABLET in 1 BOTTLE (82804-181-30)

Annotations

UNII (FDA Substance ID)
362O9ITL9D
ACETAMINOPHEN
RxCUI 161
Orange Book
A089805
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": {
    "44520aa1-b63f-4239-e063-6394a90a5e14": {
      "match": "brand_token",
      "title": "ACETAMINOPHEN LIQUID / ACETAMINOPHEN DIPHENHYDRAMINE HCL LIQUID (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) KIT [KROGER]",
      "spl_version": "2",
      "published_date": "2026-06-02"
    }
  },
  "productid": "82804-181_5d9123f6-b322-4fa0-bf48-6335a6adcbb8",
  "productndc": "82804-181",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "089805",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AA",
        "strength": "300MG;30MG",
        "product_no": "001",
        "approval_date": "Sep 30, 1988"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": "CIII",
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ACETAMINOPHEN; CODEINE PHOSPHATE",
  "shortage_reason": "Acetaminophen; Oxycodone Hydrochloride Tablet",
  "shortage_status": "current",
  "proprietary_name": "Acetaminophen and Codeine Phosphate",
  "active_ingred_unit": "mg/1; mg/1",
  "application_number": "ANDA089805",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Acetaminophen and Codeine Phosphate",
  "start_marketing_date": "20240520",
  "active_numerator_strength": "300; 30"
}

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