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United States · US · US:11822-0084_61dd37ef-591d-42c8-9bdc-bd2a6073e63b

Ibuprofen and Pseudoephedrine Hydrochloride

Orange BookUNIISPLATC C01EB

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

Identification

ManufacturerRite-Aid
CountryUS (United States)
ATC codeC01EB
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    1182200845
    1 BLISTER PACK in 1 CARTON (11822-0084-5) / 20 TABLET, COATED in 1 BLISTER PACK
  • ndc11
    1182200846
    1 BLISTER PACK in 1 CARTON (11822-0084-6) / 40 TABLET, COATED in 1 BLISTER PACK

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": "11822-0084_61dd37ef-591d-42c8-9bdc-bd2a6073e63b",
  "productndc": "11822-0084",
  "dosage_form": "TABLET, 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": "20180201",
  "active_numerator_strength": "200; 30"
}

Related drugs

Other records sharing ATC code C01EB.

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