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United States · US · US:42507-303_440c1512-fcbd-09fd-e063-6294a90aa70c

Pain Relief

Orange BookUNIISPLATC N02BE51

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

Identification

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

Packs · 1

  • ndc11
    4250730303
    1 BOTTLE, PLASTIC in 1 CARTON (42507-303-03) / 100 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC

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": {
    "bad8ac0a-518d-4639-9b92-a39e0d437238": {
      "match": "brand_token",
      "title": "PAIN AND FEVER CHEWABLES CHILDRENS (ACETAMINOPHEN) TABLET, CHEWABLE [CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED]",
      "spl_version": "2",
      "published_date": "2026-05-28"
    }
  },
  "productid": "42507-303_440c1512-fcbd-09fd-e063-6294a90aa70c",
  "productndc": "42507-303",
  "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": "Pain Relief",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA211544",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Acetaminophen",
  "start_marketing_date": "20251120",
  "active_numerator_strength": "650"
}

Related drugs

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