Back to search
🇺🇸

United States · US · US:46122-629_090568cf-d90d-2f8a-e063-6394a90a0136

8 Hour Arthritis Pain

Orange BookUNIISPLATC N02BE51

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

Identification

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

Packs · 4

  • ndc11
    4612262962
    1 BOTTLE, PLASTIC in 1 CARTON (46122-629-62) / 24 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC
  • ndc11
    4612262971
    1 BOTTLE, PLASTIC in 1 CARTON (46122-629-71) / 50 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC
  • ndc11
    4612262978
    1 BOTTLE, PLASTIC in 1 CARTON (46122-629-78) / 100 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC
  • ndc11
    4612262981
    200 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (46122-629-81)

Annotations

UNII (FDA Substance ID)
362O9ITL9D
ACETAMINOPHEN
RxCUI 161
Orange Book
A211544
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": {
    "d11a7412-a543-0e34-e053-2995a90afd63": {
      "match": "brand_token",
      "title": "8 HOUR PAIN RELIEF (ACETAMINOPHEN) TABLET, EXTENDED RELEASE [VALU MERCHANDISERS COMPANY]",
      "spl_version": "5",
      "published_date": "2025-12-12"
    }
  },
  "productid": "46122-629_090568cf-d90d-2f8a-e063-6394a90a0136",
  "productndc": "46122-629",
  "dosage_form": "TABLET, EXTENDED RELEASE",
  "orange_book": {
    "appl_no": "211544",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "650MG",
        "product_no": "001",
        "approval_date": "Apr 16, 2019"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "ACETAMINOPHEN",
  "proprietary_name": "8 Hour Arthritis Pain",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA211544",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Acetaminophen",
  "start_marketing_date": "20200113",
  "active_numerator_strength": "650"
}

Related drugs

Other records sharing ATC code N02BE51.

Access this data programmatically

Query 8 Hour Arthritis Pain and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.