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United States · US · US:59779-430_d1a8e5cf-b479-49f6-82b2-d6bd127d622d

Ibuprofen and Pseudoephedrine Hydrochloride

Orange BookUNIISPLATC C01EB

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

Identification

ManufacturerCVS Pharmacy
CountryUS (United States)
ATC codeC01EB
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    5977943041
    40 TABLET, SUGAR COATED in 1 BLISTER PACK (59779-430-41)

Annotations

UNII (FDA Substance ID)
WK2XYI10QM
IBUPROFEN
RxCUI 5640
Orange Book
A074567
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": "59779-430_d1a8e5cf-b479-49f6-82b2-d6bd127d622d",
  "productndc": "59779-430",
  "dosage_form": "TABLET, SUGAR COATED",
  "orange_book": {
    "appl_no": "074567",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "200MG;30MG",
        "product_no": "001",
        "approval_date": "Apr 17, 2001"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE",
  "proprietary_name": "Ibuprofen and Pseudoephedrine Hydrochloride",
  "active_ingred_unit": "mg/1; mg/1",
  "application_number": "ANDA074567",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Ibuprofen and Pseudoephedrine Hydrochloride",
  "start_marketing_date": "20011011",
  "active_numerator_strength": "200; 30"
}

Related drugs

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