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United States · US · US:0363-8139_94c22b51-c5b9-4970-b78a-bbe915434293

infants ibuprofen

Orange BookUNIISPLATC G02CC01

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

Identification

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

Packs · 1

  • ndc11
    0363813910
    1 BOTTLE in 1 CARTON (0363-8139-10) / 30 mL in 1 BOTTLE

Annotations

UNII (FDA Substance ID)
WK2XYI10QM
IBUPROFEN
RxCUI 5640
Orange Book
A075217
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": {
    "6509a545-0036-460a-8f0d-b31caae17855": {
      "match": "brand_token",
      "title": "INFANTS PAIN AND FEVER (ACETAMINOPHEN) SUSPENSION [AUROHEALTH LLC]",
      "spl_version": "2",
      "published_date": "2026-06-01"
    }
  },
  "productid": "0363-8139_94c22b51-c5b9-4970-b78a-bbe915434293",
  "productndc": "0363-8139",
  "dosage_form": "SUSPENSION/ DROPS",
  "orange_book": {
    "appl_no": "075217",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "40MG/ML",
        "product_no": "001",
        "approval_date": "Dec 16, 1998"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "IBUPROFEN",
  "proprietary_name": "infants ibuprofen",
  "active_ingred_unit": "mg/1.25mL",
  "application_number": "ANDA075217",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Ibuprofen",
  "start_marketing_date": "20240109",
  "active_numerator_strength": "50"
}

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