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United States · US · US:51672-5321_b7b5ccd2-1de9-4b93-b2bb-09bc540704fd

ibuprofen

Orange BookUNIISPLATC G02CC01

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

Identification

ManufacturerTARO PHARMACEUTICALS U.S.A., INC.
CountryUS (United States)
ATC codeG02CC01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    5167253211
    1 BOTTLE, PLASTIC in 1 CARTON (51672-5321-1) / 240 mL in 1 BOTTLE, PLASTIC
  • ndc11
    5167253218
    1 BOTTLE, PLASTIC in 1 CARTON (51672-5321-8) / 120 mL in 1 BOTTLE, PLASTIC

Annotations

UNII (FDA Substance ID)
WK2XYI10QM
IBUPROFEN
RxCUI 5640
Orange Book
A211666
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": "51672-5321_b7b5ccd2-1de9-4b93-b2bb-09bc540704fd",
  "productndc": "51672-5321",
  "dosage_form": "SUSPENSION",
  "orange_book": {
    "appl_no": "211666",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "100MG/5ML",
        "product_no": "001",
        "approval_date": "Feb 22, 2021"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "IBUPROFEN",
  "proprietary_name": "ibuprofen",
  "active_ingred_unit": "mg/5mL",
  "application_number": "ANDA211666",
  "marketing_category": "ANDA",
  "nonproprietary_name": "ibuprofen",
  "start_marketing_date": "20240815",
  "active_numerator_strength": "100"
}

Related drugs

Other records sharing ATC code G02CC01.

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