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United States · US · US:68210-0800_28ed10e2-9113-a062-e063-6394a90a0ba3

VALUMEDS IBUPROFEN

Orange BookUNIISPLATC G02CC01

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

Identification

ManufacturerSPIRIT PHARMACEUTICALS LLC
CountryUS (United States)
ATC codeG02CC01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    6821008001
    100 TABLET, FILM COATED in 1 BOTTLE (68210-0800-1)
  • ndc11
    6821008004
    1 BOTTLE in 1 CARTON (68210-0800-4) / 40 TABLET, FILM COATED in 1 BOTTLE

Annotations

UNII (FDA Substance ID)
WK2XYI10QM
IBUPROFEN
RxCUI 5640
Orange Book
A091239
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": {
    "43bc8e38-bd74-411c-b4fe-7d809d24ae46": {
      "match": "brand_token",
      "title": "VALUMEDS ALLERGY RELIEF LORATADINE (LORATADINE) TABLET [CABINET HEALTH P.B.C.]",
      "spl_version": "2",
      "published_date": "2026-05-21"
    }
  },
  "productid": "68210-0800_28ed10e2-9113-a062-e063-6394a90a0ba3",
  "productndc": "68210-0800",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "091239",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "200MG",
        "product_no": "001",
        "approval_date": "Feb 1, 2011"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "IBUPROFEN",
  "proprietary_name": "VALUMEDS IBUPROFEN",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA091239",
  "marketing_category": "ANDA",
  "nonproprietary_name": "IBUPROFEN",
  "start_marketing_date": "20170519",
  "active_numerator_strength": "200"
}

Related drugs

Other records sharing ATC code G02CC01.

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