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United States · US · US:69729-137_26f56cb7-be59-a0c2-e063-6294a90a15fa

Pentrexcilina Day time

Orange BookUNIISPLATC R06AE

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

Identification

ManufacturerOPMX LLC
CountryUS (United States)
ATC codeR06AE
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    6972913714
    14 TABLET in 1 BOTTLE (69729-137-14)

Annotations

UNII (FDA Substance ID)
64O047KTOA
CETIRIZINE HYDROCHLORIDE
RxCUI 203150
Orange Book
A209274
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "64O047KTOA",
    "rxcui": "203150",
    "inchikey": "PGLIUCLTXOYQMV-UHFFFAOYSA-N",
    "display_name": "CETIRIZINE HYDROCHLORIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "e11e5c17-28f2-7186-e053-2995a90a51f6": {
      "match": "brand_token",
      "title": "PENTREXCILINA NIGHT TIME (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) CAPSULE, LIQUID FILLED [OPMX LLC]",
      "spl_version": "3",
      "published_date": "2025-07-21"
    }
  },
  "productid": "69729-137_26f56cb7-be59-a0c2-e063-6294a90a15fa",
  "productndc": "69729-137",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "209274",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "10MG",
        "product_no": "001",
        "approval_date": "Dec 22, 2017"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "CETIRIZINE HYDROCHLORIDE",
  "proprietary_name": "Pentrexcilina Day time",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA209274",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Cetirizine Hydrochloride",
  "start_marketing_date": "20241115",
  "active_numerator_strength": "10"
}

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