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United States · US · US:0264-4100_011c0907-df72-4a78-9c37-0a65f9a48994

Acetaminophen

Orange BookUNIISPLATC N02BE51

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

Identification

ManufacturerB. Braun Medical Inc.
CountryUS (United States)
ATC codeN02BE51
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    0264410090
    24 CONTAINER in 1 CASE (0264-4100-90) / 100 mL in 1 CONTAINER

Annotations

UNII (FDA Substance ID)
362O9ITL9D
ACETAMINOPHEN
RxCUI 161
Orange Book
N204957
APAP2
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": "0264-4100_011c0907-df72-4a78-9c37-0a65f9a48994",
  "productndc": "0264-4100",
  "dosage_form": "INJECTION",
  "orange_book": {
    "appl_no": "204957",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": "AP",
        "strength": "500MG/50ML (10MG/ML)",
        "product_no": "001",
        "approval_date": "Feb 18, 2021"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AP2",
        "strength": "1GM/100ML (10MG/ML)",
        "product_no": "002",
        "approval_date": "Feb 18, 2021"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ACETAMINOPHEN",
  "proprietary_name": "Acetaminophen",
  "active_ingred_unit": "mg/mL",
  "application_number": "NDA204957",
  "marketing_category": "NDA",
  "nonproprietary_name": "Acetaminophen",
  "start_marketing_date": "20210218",
  "active_numerator_strength": "10"
}

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