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United States · US · US:50580-120_460cceff-0b2e-cbfe-e063-6394a90aa46f

Motrin IB Migraine

Orange BookUNIISPLATC G02CC01

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

Identification

ManufacturerKenvue Brands LLC
CountryUS (United States)
ATC codeG02CC01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    5058012020
    1 BOTTLE, PLASTIC in 1 CARTON (50580-120-20) / 20 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC
  • ndc11
    5058012080
    1 BOTTLE, PLASTIC in 1 CARTON (50580-120-80) / 80 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC

Annotations

UNII (FDA Substance ID)
WK2XYI10QM
IBUPROFEN
RxCUI 5640
Orange Book
A078682
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": {
    "c57f6ded-c0bd-45ae-823a-4c02ce334d98": {
      "match": "brand_token",
      "title": "MOTRIN INFANTS (IBUPROFEN) SUSPENSION/ DROPS [KENVUE BRANDS LLC]",
      "spl_version": "17",
      "published_date": "2026-05-20"
    }
  },
  "productid": "50580-120_460cceff-0b2e-cbfe-e063-6394a90aa46f",
  "productndc": "50580-120",
  "dosage_form": "CAPSULE, LIQUID FILLED",
  "orange_book": {
    "appl_no": "078682",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "EQ 200MG FREE ACID AND POTASSIUM SALT",
        "product_no": "001",
        "approval_date": "Mar 24, 2009"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "IBUPROFEN",
  "proprietary_name": "Motrin IB Migraine",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA078682",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Ibuprofen",
  "start_marketing_date": "20210118",
  "active_numerator_strength": "200"
}

Related drugs

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