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United States · US · US:36000-372_8656ca5b-eba7-4812-b423-aab2ee0a16de

Acetaminophen

Orange BookUNIISPLATC N02BE51

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

Identification

ManufacturerBaxter Healthcare Corporation
CountryUS (United States)
ATC codeN02BE51
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    3600037240
    40 BAG in 1 CARTON (36000-372-40) / 65 mL in 1 BAG

Annotations

UNII (FDA Substance ID)
362O9ITL9D
ACETAMINOPHEN
RxCUI 161
Orange Book
A214331
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": "36000-372_8656ca5b-eba7-4812-b423-aab2ee0a16de",
  "productndc": "36000-372",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "214331",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP1",
        "strength": "1GM/100ML (10MG/ML)",
        "product_no": "001",
        "approval_date": "Sep 17, 2021"
      },
      {
        "rs": true,
        "rld": false,
        "te_code": null,
        "strength": "650MG/65ML (10MG/ML)",
        "product_no": "002",
        "approval_date": "May 21, 2025"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ACETAMINOPHEN",
  "proprietary_name": "Acetaminophen",
  "active_ingred_unit": "mg/mL",
  "application_number": "ANDA214331",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Acetaminophen",
  "start_marketing_date": "20250521",
  "active_numerator_strength": "10"
}

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