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United States · US · US:0904-6747_dddfc800-cfd3-42d4-82e1-04414822fbfc

ibuprofen

Orange BookUNIISPLATC G02CC01

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

Identification

ManufacturerMajor Pharmaceuticals
CountryUS (United States)
ATC codeG02CC01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 6

  • ndc11
    0904674724
    1 BOTTLE in 1 CARTON (0904-6747-24) / 24 TABLET, FILM COATED in 1 BOTTLE
  • ndc11
    0904674740
    500 TABLET, FILM COATED in 1 BOTTLE (0904-6747-40)
  • ndc11
    0904674751
    1 BOTTLE in 1 CARTON (0904-6747-51) / 50 TABLET, FILM COATED in 1 BOTTLE
  • ndc11
    0904674759
    1 BOTTLE in 1 CARTON (0904-6747-59) / 100 TABLET, FILM COATED in 1 BOTTLE
  • ndc11
    0904674770
    1 BOTTLE in 1 CARTON (0904-6747-70) / 250 TABLET, FILM COATED in 1 BOTTLE
  • ndc11
    0904674780
    1000 TABLET, FILM COATED in 1 BOTTLE (0904-6747-80)

Annotations

UNII (FDA Substance ID)
WK2XYI10QM
IBUPROFEN
RxCUI 5640
Orange Book
A072096
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": "0904-6747_dddfc800-cfd3-42d4-82e1-04414822fbfc",
  "productndc": "0904-6747",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "072096",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "200MG",
        "product_no": "001",
        "approval_date": "Dec 8, 1987"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "IBUPROFEN",
  "proprietary_name": "ibuprofen",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA072096",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Ibuprofen",
  "start_marketing_date": "20180920",
  "active_numerator_strength": "200"
}

Related drugs

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