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United States · US · US:44567-340_ffa85b8b-2890-4f03-aaaa-816a181f048c

Acetaminophen

Orange BookUNIISPLATC N02BE51

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

Identification

ManufacturerWG Critical Care, LLC
CountryUS (United States)
ATC codeN02BE51
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    4456734010
    10 BAG in 1 CARTON (44567-340-10) / 100 mL in 1 BAG (44567-340-01)

Annotations

UNII (FDA Substance ID)
362O9ITL9D
ACETAMINOPHEN
RxCUI 161
Orange Book
A215403
AP1
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "362O9ITL9D",
    "rxcui": "161",
    "inchikey": "RZVAJINKPMORJF-UHFFFAOYSA-N",
    "display_name": "ACETAMINOPHEN",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAVENOUS",
  "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": "44567-340_ffa85b8b-2890-4f03-aaaa-816a181f048c",
  "productndc": "44567-340",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "215403",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP1",
        "strength": "1GM/100ML (10MG/ML)",
        "product_no": "001",
        "approval_date": "May 3, 2023"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ACETAMINOPHEN",
  "proprietary_name": "Acetaminophen",
  "active_ingred_unit": "mg/mL",
  "application_number": "ANDA215403",
  "marketing_category": "ANDA",
  "nonproprietary_name": "acetaminophen",
  "start_marketing_date": "20230503",
  "active_numerator_strength": "10"
}

Related drugs

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