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United States · US · US:50090-4629_51527d7c-26f4-4538-928e-f3ac2bba4f84

Sudafed Sinus Congestion 12 Hour

Orange BookUNIISPLATC R01BA52

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

Identification

ManufacturerA-S Medication Solutions
CountryUS (United States)
ATC codeR01BA52
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    5009046290
    1 BLISTER PACK in 1 CARTON (50090-4629-0) / 10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK

Annotations

UNII (FDA Substance ID)
6V9V2RYJ8N
PSEUDOEPHEDRINE HYDROCHLORIDE
RxCUI 91168
Orange Book
A075153
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "6V9V2RYJ8N",
    "rxcui": "91168",
    "inchikey": "BALXUFOVQVENIU-KXNXZCPBSA-N",
    "display_name": "PSEUDOEPHEDRINE HYDROCHLORIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "67428f4b-28be-4682-a9a9-781bf85089ff": {
      "match": "brand_token",
      "title": "SUDAFED PE SINUS PRESSURE PLUS PAIN (ACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, FILM COATED [SPORTPHARM LLC]",
      "spl_version": "1",
      "published_date": "2026-03-12"
    }
  },
  "productid": "50090-4629_51527d7c-26f4-4538-928e-f3ac2bba4f84",
  "productndc": "50090-4629",
  "dosage_form": "TABLET, FILM COATED, EXTENDED RELEASE",
  "orange_book": {
    "appl_no": "075153",
    "products": [
      {
        "rs": true,
        "rld": false,
        "te_code": null,
        "strength": "120MG",
        "product_no": "001",
        "approval_date": "Feb 26, 1999"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "PSEUDOEPHEDRINE HYDROCHLORIDE",
  "proprietary_name": "Sudafed Sinus Congestion 12 Hour",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA075153",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Pseudoephedrine Hydrochloride",
  "start_marketing_date": "20190617",
  "active_numerator_strength": "120"
}

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