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United States · US · US:41520-740_abf6140f-e0f5-4034-aec8-15ca8acc5d0b

careone childrens ibuprofen

Orange BookUNIISPLATC G02CC01

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

Identification

ManufacturerAmerican Sales Company
CountryUS (United States)
ATC codeG02CC01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    4152074062
    1 BOTTLE in 1 CARTON (41520-740-62) / 24 TABLET, CHEWABLE in 1 BOTTLE

Annotations

UNII (FDA Substance ID)
WK2XYI10QM
IBUPROFEN
RxCUI 5640
Orange Book
A076359
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "WK2XYI10QM",
    "rxcui": "5640",
    "inchikey": "HEFNNWSXXWATRW-UHFFFAOYSA-N",
    "display_name": "IBUPROFEN",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "206f5483-7de1-4bc3-af27-190e211bcb95": {
      "match": "brand_token",
      "title": "CAREONE ACID RELIEF (FAMOTIDINE) TABLET, FILM COATED [AMERICAN SALES COMPANY]",
      "spl_version": "9",
      "published_date": "2026-05-25"
    }
  },
  "productid": "41520-740_abf6140f-e0f5-4034-aec8-15ca8acc5d0b",
  "productndc": "41520-740",
  "dosage_form": "TABLET, CHEWABLE",
  "orange_book": {
    "appl_no": "076359",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "50MG",
        "product_no": "001",
        "approval_date": "Jan 16, 2004"
      },
      {
        "rs": true,
        "rld": false,
        "te_code": null,
        "strength": "100MG",
        "product_no": "002",
        "approval_date": "Jan 16, 2004"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "IBUPROFEN",
  "proprietary_name": "careone childrens ibuprofen",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA076359",
  "marketing_category": "ANDA",
  "nonproprietary_name": "ibuprofen",
  "start_marketing_date": "20190724",
  "active_numerator_strength": "100"
}

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