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United States · US · US:0113-2017_98b199af-35e9-4582-9d3f-129d0696172f

sinus 12 hour

Orange BookUNIISPLATC R01BA52

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

Identification

ManufacturerL. Perrigo Company
CountryUS (United States)
ATC codeR01BA52
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    0113201760
    20 BLISTER PACK in 1 CARTON (0113-2017-60) / 1 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": {
    "e9dd2d7b-0a19-4a42-b51e-b9914f02406e": {
      "match": "brand_token",
      "title": "SINUS CONGESTION AND PAIN DAYTIME NON-DROWSY (ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE) TABLET, FILM COATED [H E B]",
      "spl_version": "15",
      "published_date": "2026-05-25"
    }
  },
  "productid": "0113-2017_98b199af-35e9-4582-9d3f-129d0696172f",
  "productndc": "0113-2017",
  "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": "sinus 12 hour",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA075153",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Pseudoephedrine HCl",
  "start_marketing_date": "20170929",
  "active_numerator_strength": "120"
}

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