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United States · US · US:50269-000_2a458f6d-e744-1cd1-e063-6394a90a36a5

MOTRIN IB

Orange BookUNIISPLATC G02CC01

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

Identification

ManufacturerJC World Bell Wholesale Co., Inc.
CountryUS (United States)
ATC codeG02CC01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    5026900001
    6 BLISTER PACK in 1 BOX (50269-000-01) / 1 POUCH in 1 BLISTER PACK / 2 TABLET, FILM COATED in 1 POUCH
  • ndc11
    5026900025
    25 POUCH in 1 BOX (50269-000-25) / 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": "50269-000_2a458f6d-e744-1cd1-e063-6394a90a36a5",
  "productndc": "50269-000",
  "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": "20181210",
  "active_numerator_strength": "200"
}

Related drugs

Other records sharing ATC code G02CC01.

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