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United States · US · US:43598-052_49a54544-f18b-6461-9ed0-2740e8df4b6c

Acetaminophen 250 mg and Ibuprofen 125 mg

In shortageOrange BookUNIISPLATC N02BE

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

Identification

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

Packs · 5

  • ndc11
    4359805205
    500 TABLET, FILM COATED in 1 BOTTLE (43598-052-05)
  • ndc11
    4359805214
    144 TABLET, FILM COATED in 1 BOTTLE (43598-052-14)
  • ndc11
    4359805218
    1 BOTTLE in 1 CARTON (43598-052-18) / 18 TABLET, FILM COATED in 1 BOTTLE
  • ndc11
    4359805225
    1 BOTTLE in 1 CARTON (43598-052-25) / 250 TABLET, FILM COATED in 1 BOTTLE
  • ndc11
    4359805295
    250 TABLET, FILM COATED in 1 BOTTLE (43598-052-95)

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": {
    "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": "43598-052_49a54544-f18b-6461-9ed0-2740e8df4b6c",
  "productndc": "43598-052",
  "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": "Acetaminophen 250 mg and Ibuprofen 125 mg",
  "active_ingred_unit": "mg/1; mg/1",
  "application_number": "ANDA218247",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Acetaminophen and Ibuprofen",
  "start_marketing_date": "20250219",
  "active_numerator_strength": "250; 125"
}

Related drugs

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