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United States · US · US:55758-310_0542f88c-b29d-d32c-e063-6294a90ab9ee

Dolex Flex

Orange BookUNIISPLATC G02CC01

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

Identification

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

Packs · 0

No packs registered.

Annotations

UNII (FDA Substance ID)
WK2XYI10QM
IBUPROFEN
RxCUI 5640
Orange Book
A206999
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": {
    "0543420d-a250-065d-e063-6294a90a005e": {
      "match": "brand_token",
      "title": "DOLEX FLEX (IBUPROFEN) CAPSULE, LIQUID FILLED [PHARMADEL LLC]",
      "spl_version": "5",
      "published_date": "2026-03-23"
    }
  },
  "productid": "55758-310_0542f88c-b29d-d32c-e063-6294a90ab9ee",
  "productndc": "55758-310",
  "dosage_form": "CAPSULE, LIQUID FILLED",
  "orange_book": {
    "appl_no": "206999",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "EQ 200MG FREE ACID AND POTASSIUM SALT",
        "product_no": "001",
        "approval_date": "Dec 21, 2017"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "IBUPROFEN",
  "proprietary_name": "Dolex Flex",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA206999",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Ibuprofen",
  "start_marketing_date": "20191031",
  "active_numerator_strength": "200"
}

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