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United States · US · US:0904-7561_34388d07-02d7-72f3-e063-6294a90a6901

8hr arthritis pain relief

Orange BookUNIISPLATC N02BE51

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

Identification

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

Packs · 1

  • ndc11
    0904756160
    100 TABLET, EXTENDED RELEASE in 1 BOTTLE (0904-7561-60)

Annotations

UNII (FDA Substance ID)
362O9ITL9D
ACETAMINOPHEN
RxCUI 161
Orange Book
A215486
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": {
    "2eb6eba1-46af-32a4-e063-6294a90a499c": {
      "match": "brand_token",
      "title": "8HR ARTHRITIS PAIN RELIEF (ACETAMINOPHEN 650MG) TABLET, EXTENDED RELEASE [CVS PHARMACY]",
      "spl_version": "3",
      "published_date": "2026-04-29"
    }
  },
  "productid": "0904-7561_34388d07-02d7-72f3-e063-6294a90a6901",
  "productndc": "0904-7561",
  "dosage_form": "TABLET, EXTENDED RELEASE",
  "orange_book": {
    "appl_no": "215486",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "650MG",
        "product_no": "001",
        "approval_date": "Aug 25, 2021"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "ACETAMINOPHEN",
  "proprietary_name": "8hr arthritis pain relief",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA215486",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Acetaminophen",
  "start_marketing_date": "20250506",
  "active_numerator_strength": "650"
}

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