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United States · US · US:69842-092_061cf29a-2116-4ec4-be03-68d22da02b3e

Ibuprofen and Pseudoephedrine HCl

Orange BookUNIISPLATC C01EB

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

Identification

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

Packs · 2

  • ndc11
    6984209213
    4 BLISTER PACK in 1 CARTON (69842-092-13) / 8 CAPSULE, LIQUID FILLED in 1 BLISTER PACK
  • ndc11
    6984209267
    2 BLISTER PACK in 1 CARTON (69842-092-67) / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK

Annotations

UNII (FDA Substance ID)
WK2XYI10QM
IBUPROFEN
RxCUI 5640
Orange Book
A209235
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": "69842-092_061cf29a-2116-4ec4-be03-68d22da02b3e",
  "productndc": "69842-092",
  "dosage_form": "CAPSULE, LIQUID FILLED",
  "orange_book": {
    "appl_no": "209235",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "EQ 200MG FREE ACID AND POTASSIUM SALT;30MG",
        "product_no": "001",
        "approval_date": "Dec 1, 2017"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE",
  "proprietary_name": "Ibuprofen and Pseudoephedrine HCl",
  "active_ingred_unit": "mg/1; mg/1",
  "application_number": "ANDA209235",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Ibuprofen and Pseudoephedrine HCl",
  "start_marketing_date": "20171201",
  "active_numerator_strength": "200; 30"
}

Related drugs

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