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United States · US · US:45802-732_804d45c6-9798-4374-896a-a1f15e40077a

acetaminophen

Orange BookUNIISPLATC N02BE51

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

Identification

ManufacturerPadagis Israel Pharmaceuticals Ltd
CountryUS (United States)
ATC codeN02BE51
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    4580273230
    12 BLISTER PACK in 1 CARTON (45802-732-30) / 1 SUPPOSITORY in 1 BLISTER PACK
  • ndc11
    4580273233
    100 BLISTER PACK in 1 CARTON (45802-732-33) / 1 SUPPOSITORY in 1 BLISTER PACK

Annotations

UNII (FDA Substance ID)
362O9ITL9D
ACETAMINOPHEN
RxCUI 161
Orange Book
A070607
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": "RECTAL",
  "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": "45802-732_804d45c6-9798-4374-896a-a1f15e40077a",
  "productndc": "45802-732",
  "dosage_form": "SUPPOSITORY",
  "orange_book": {
    "appl_no": "070607",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "120MG",
        "product_no": "001",
        "approval_date": "Apr 6, 1987"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "ACETAMINOPHEN",
  "proprietary_name": "acetaminophen",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA070607",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Acetaminophen",
  "start_marketing_date": "20101214",
  "active_numerator_strength": "120"
}

Related drugs

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