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United States · US · US:36800-705_4863e91d-f16d-4a61-8f24-5889fa59a2a3

topcare ibuprofen

Orange BookUNIISPLATC G02CC01

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

Identification

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

Packs · 1

  • ndc11
    3680070506
    1 BOTTLE in 1 CARTON (36800-705-06) / 160 CAPSULE, LIQUID FILLED in 1 BOTTLE

Annotations

UNII (FDA Substance ID)
WK2XYI10QM
IBUPROFEN
RxCUI 5640
Orange Book
A203599
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": {
    "a88e5b8e-e6dd-4a1c-9628-5861d3205bdb": {
      "match": "brand_token",
      "title": "TOPCARE DAY TIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) SOLUTION [TOPCO ASSOCIATES LLC]",
      "spl_version": "10",
      "published_date": "2026-06-01"
    }
  },
  "productid": "36800-705_4863e91d-f16d-4a61-8f24-5889fa59a2a3",
  "productndc": "36800-705",
  "dosage_form": "CAPSULE, LIQUID FILLED",
  "orange_book": {
    "appl_no": "203599",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "EQ 200MG FREE ACID AND POTASSIUM SALT",
        "product_no": "001",
        "approval_date": "Sep 7, 2016"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "IBUPROFEN",
  "proprietary_name": "topcare ibuprofen",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA203599",
  "marketing_category": "ANDA",
  "nonproprietary_name": "ibuprofen",
  "start_marketing_date": "20210924",
  "active_numerator_strength": "200"
}

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