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United States · US · US:79903-244_464fe21f-7b71-6aef-e063-6294a90a03f8

Acetaminophen and Ibuprofen

In shortageOrange BookUNIISPLATC N02BE

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

Identification

ManufacturerWAL-MART STORES INC.
CountryUS (United States)
ATC codeN02BE
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    7990324444
    144 TABLET in 1 BOTTLE (79903-244-44)

Annotations

UNII (FDA Substance ID)
362O9ITL9D
ACETAMINOPHEN
RxCUI 161
Orange Book
A216592
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": "79903-244_464fe21f-7b71-6aef-e063-6294a90a03f8",
  "productndc": "79903-244",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "216592",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "250MG;125MG",
        "product_no": "001",
        "approval_date": "Jul 13, 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": "Acetaminophen and Ibuprofen",
  "active_ingred_unit": "mg/1; mg/1",
  "application_number": "ANDA216592",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Acetaminophen and Ibuprofen",
  "start_marketing_date": "20240205",
  "active_numerator_strength": "250; 125"
}

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