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United States · US · US:70677-0150_e5e79c54-bf94-3d7d-e053-2995a90a3812

Ibuprofen Oral

Orange BookUNIISPLATC G02CC01

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

Identification

ManufacturerStrategic Sourcing Services
CountryUS (United States)
ATC codeG02CC01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    7067701501
    1 BOTTLE in 1 CARTON (70677-0150-1) / 118 mL in 1 BOTTLE
  • ndc11
    7067701502
    1 BOTTLE in 1 CARTON (70677-0150-2) / 237 mL in 1 BOTTLE

Annotations

UNII (FDA Substance ID)
WK2XYI10QM
IBUPROFEN
RxCUI 5640
Orange Book
A210602
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": "70677-0150_e5e79c54-bf94-3d7d-e053-2995a90a3812",
  "productndc": "70677-0150",
  "dosage_form": "SUSPENSION",
  "orange_book": {
    "appl_no": "210602",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "100MG/5ML",
        "product_no": "001",
        "approval_date": "Nov 23, 2018"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "IBUPROFEN",
  "proprietary_name": "Ibuprofen Oral",
  "active_ingred_unit": "mg/5mL",
  "application_number": "ANDA210602",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Ibuprofen Oral",
  "start_marketing_date": "20181123",
  "active_numerator_strength": "100"
}

Related drugs

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