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United States · US · US:51672-4258_4cb287fd-c316-032c-e063-6294a90a6ffe

Acetaminophen 250 mg and Ibuprofen 125 mg

In shortageOrange BookUNIISPLATC N02BE

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

Identification

ManufacturerSun Pharmaceutical Industries, Inc.
CountryUS (United States)
ATC codeN02BE
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    5167242581
    1 BOTTLE in 1 CARTON (51672-4258-1) / 216 TABLET in 1 BOTTLE
  • ndc11
    5167242584
    1 BOTTLE in 1 CARTON (51672-4258-4) / 72 TABLET in 1 BOTTLE

Annotations

UNII (FDA Substance ID)
362O9ITL9D
ACETAMINOPHEN
RxCUI 161
Orange Book
A219053
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": "51672-4258_4cb287fd-c316-032c-e063-6294a90a6ffe",
  "productndc": "51672-4258",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "219053",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "250MG;125MG",
        "product_no": "001",
        "approval_date": "Jan 2, 2026"
      }
    ],
    "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": "Acetaminophen 250 mg and Ibuprofen 125 mg",
  "active_ingred_unit": "mg/1; mg/1",
  "application_number": "ANDA219053",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Acetaminophen 250 mg and Ibuprofen 125 mg Tablets",
  "start_marketing_date": "20260315",
  "active_numerator_strength": "250; 125"
}

Related drugs

Other records sharing ATC code N02BE.

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