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United States · US · US:0363-9604_e6c2e68f-9711-4b57-b72b-ece33e19edc6

Acetaminophen

Orange BookUNIISPLATC N02BE51

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

Identification

ManufacturerWALGREEN CO.
CountryUS (United States)
ATC codeN02BE51
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    0363960407
    1 BOTTLE in 1 CARTON (0363-9604-07) / 24 TABLET, EXTENDED RELEASE in 1 BOTTLE
  • ndc11
    0363960435
    1 BOTTLE in 1 CARTON (0363-9604-35) / 225 TABLET, EXTENDED RELEASE in 1 BOTTLE

Annotations

UNII (FDA Substance ID)
362O9ITL9D
ACETAMINOPHEN
RxCUI 161
Orange Book
A207229
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": "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": "0363-9604_e6c2e68f-9711-4b57-b72b-ece33e19edc6",
  "productndc": "0363-9604",
  "dosage_form": "TABLET, EXTENDED RELEASE",
  "orange_book": {
    "appl_no": "207229",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "650MG",
        "product_no": "001",
        "approval_date": "Nov 9, 2016"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "ACETAMINOPHEN",
  "proprietary_name": "Acetaminophen",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA207229",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Acetaminophen",
  "start_marketing_date": "20210707",
  "active_numerator_strength": "650"
}

Related drugs

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