Motrin IB

Orange BookUNIISPLATC G02CC01

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerKenvue Brands LLC

CountryUS (United States)

ATC codeG02CC01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 9

ndc11
5058023001
1 BOTTLE in 1 CARTON (50580-230-01) / 50 TABLET, FILM COATED in 1 BOTTLE
ndc11
5058023002
1 BOTTLE in 1 CARTON (50580-230-02) / 60 TABLET, FILM COATED in 1 BOTTLE
ndc11
5058023003
1 BOTTLE in 1 CARTON (50580-230-03) / 100 TABLET, FILM COATED in 1 BOTTLE
ndc11
5058023004
1 BOTTLE in 1 CARTON (50580-230-04) / 225 TABLET, FILM COATED in 1 BOTTLE
ndc11
5058023005
1 BOTTLE in 1 CARTON (50580-230-05) / 300 TABLET, FILM COATED in 1 BOTTLE
ndc11
5058023006
1 BOTTLE in 1 CARTON (50580-230-06) / 500 TABLET, FILM COATED in 1 BOTTLE
ndc11
5058023007
1 BOTTLE in 1 CARTON (50580-230-07) / 24 TABLET, FILM COATED in 1 BOTTLE
ndc11
5058023008
2 TABLET, FILM COATED in 1 POUCH (50580-230-08)
ndc11
5058023009
50 POUCH in 1 CARTON (50580-230-09) / 2 TABLET, FILM COATED in 1 POUCH

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": "50580-230_4003a46c-d99c-72f4-e063-6394a90ab2db",
  "productndc": "50580-230",
  "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": "20160701",
  "active_numerator_strength": "200"
}

Related drugs

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