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United States · US · US:70677-0001_a6862b77-0e04-41d5-927f-6b521df4b34c

nasal decongestant

Orange BookUNIISPLATC R01BA52

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

Identification

ManufacturerStrategic Sourcing Services
CountryUS (United States)
ATC codeR01BA52
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    7067700011
    1 BLISTER PACK in 1 CARTON (70677-0001-1) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK

Annotations

UNII (FDA Substance ID)
6V9V2RYJ8N
PSEUDOEPHEDRINE HYDROCHLORIDE
RxCUI 91168
Orange Book
A077442
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": {
    "0ae25bc9-5d90-4dd8-9620-8684c4fd9d37": {
      "match": "brand_token",
      "title": "NASAL ALLERGY (TRIAMCINOLONE ACETONIDE) SPRAY, METERED [RUGBY LABORATORIES]",
      "spl_version": "5",
      "published_date": "2026-05-25"
    }
  },
  "productid": "70677-0001_a6862b77-0e04-41d5-927f-6b521df4b34c",
  "productndc": "70677-0001",
  "dosage_form": "TABLET, EXTENDED RELEASE",
  "orange_book": {
    "appl_no": "077442",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "120MG",
        "product_no": "001",
        "approval_date": "Sep 28, 2005"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "PSEUDOEPHEDRINE HYDROCHLORIDE",
  "proprietary_name": "nasal decongestant",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA077442",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Pseudoephedrine Hydrochloride",
  "start_marketing_date": "20180405",
  "active_numerator_strength": "120"
}

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