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United States · US · US:75907-158_ac5bcacf-74a8-2803-2157-fa190e092558

Dual Action

In shortageOrange BookUNIISPLATC N02BE

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

Identification

ManufacturerDr. Reddy's Laboratories Inc
CountryUS (United States)
ATC codeN02BE
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    7590715814
    144 TABLET, FILM COATED in 1 BOTTLE (75907-158-14)
  • ndc11
    7590715825
    250 TABLET, FILM COATED in 1 BOTTLE (75907-158-25)

Annotations

UNII (FDA Substance ID)
362O9ITL9D
ACETAMINOPHEN
RxCUI 161
Orange Book
A218247
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": "75907-158_ac5bcacf-74a8-2803-2157-fa190e092558",
  "productndc": "75907-158",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "218247",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "250MG;125MG",
        "product_no": "001",
        "approval_date": "Aug 23, 2024"
      }
    ],
    "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",
  "active_ingred_unit": "mg/1; mg/1",
  "application_number": "ANDA218247",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Acetaminophen and Ibuprofen (NSAID) Tablets, 250 mg/ 125 mg",
  "start_marketing_date": "20250206",
  "active_numerator_strength": "250; 125"
}

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