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United States · US · US:63868-470_f0d3a221-4870-abc3-e053-2995a90aa4be

Ibuprofen

Orange BookUNIISPLATC G02CC01

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

Identification

ManufacturerChain Drug Marketing Association, Inc.
CountryUS (United States)
ATC codeG02CC01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 3

  • ndc11
    6386847020
    1 BOTTLE in 1 CARTON (63868-470-20) / 20 CAPSULE, LIQUID FILLED in 1 BOTTLE
  • ndc11
    6386847048
    1 BOTTLE in 1 CARTON (63868-470-48) / 48 CAPSULE, LIQUID FILLED in 1 BOTTLE
  • ndc11
    6386847080
    1 BOTTLE in 1 CARTON (63868-470-80) / 80 CAPSULE, LIQUID FILLED in 1 BOTTLE

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": {
    "aeee629b-255c-40d8-8e95-779aec00f723": {
      "match": "brand_token",
      "title": "IBUPROFEN TABLET [NORTHSTAR RX LLC]",
      "spl_version": "1",
      "published_date": "2026-06-02"
    }
  },
  "productid": "63868-470_f0d3a221-4870-abc3-e053-2995a90aa4be",
  "productndc": "63868-470",
  "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": "Ibuprofen",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA078682",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Ibuprofen",
  "start_marketing_date": "20191009",
  "active_numerator_strength": "200"
}

Related drugs

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