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United States · US · US:83324-149_2397603c-8d88-2e65-e063-6394a90ab73e

dual action pain reliever

In shortageOrange BookUNIISPLATC N02BE

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

Identification

ManufacturerCHAIN DRUG MARKETING ASSOCIATION INC.
CountryUS (United States)
ATC codeN02BE
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    8332414936
    1 BOTTLE in 1 CARTON (83324-149-36) / 36 TABLET, FILM COATED in 1 BOTTLE

Annotations

UNII (FDA Substance ID)
362O9ITL9D
ACETAMINOPHEN
RxCUI 161
Orange Book
A216999
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": {
    "8d9a0c56-ef22-45a6-8b1d-d2b2f3247210": {
      "match": "brand_token",
      "title": "DUAL ACTION BACK PAIN RELIEVER (ACETAMINOPHEN, IBUPROFEN) TABLET, FILM COATED [MEIJER, INC.]",
      "spl_version": "2",
      "published_date": "2026-03-23"
    }
  },
  "productid": "83324-149_2397603c-8d88-2e65-e063-6394a90ab73e",
  "productndc": "83324-149",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "216999",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "250MG;125MG",
        "product_no": "001",
        "approval_date": "Aug 1, 2023"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "ACETAMINOPHEN; IBUPROFEN",
  "shortage_reason": "Acetaminophen; Oxycodone Hydrochloride Tablet",
  "shortage_status": "current",
  "proprietary_name": "dual action pain reliever",
  "active_ingred_unit": "mg/1; mg/1",
  "application_number": "ANDA216999",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Acetaminophen and Ibuprofen",
  "start_marketing_date": "20241003",
  "active_numerator_strength": "250; 125"
}

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