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United States · US · US:53209-2001_37e92a7b-971f-c212-e063-6394a90ad710

Motrin IB

Orange BookUNIISPLATC G02CC01

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

Identification

ManufacturerMorning Star OTC
CountryUS (United States)
ATC codeG02CC01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    5320920012
    25 BLISTER PACK in 1 POUCH (53209-2001-2) / 2 TABLET, FILM COATED in 1 BLISTER PACK (53209-2001-1)

Annotations

UNII (FDA Substance ID)
WK2XYI10QM
IBUPROFEN
RxCUI 5640
Orange Book
A077349
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": "53209-2001_37e92a7b-971f-c212-e063-6394a90ad710",
  "productndc": "53209-2001",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "077349",
    "products": [
      {
        "rs": true,
        "rld": false,
        "te_code": null,
        "strength": "200MG",
        "product_no": "001",
        "approval_date": "Jun 21, 2005"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "IBUPROFEN",
  "proprietary_name": "Motrin IB",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA077349",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Ibuprofen",
  "start_marketing_date": "20250619",
  "active_numerator_strength": "200"
}

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