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United States · US · US:41226-692_3e7fad54-62e1-6d0a-e063-6394a90a5785

ALLERGY

Orange BookUNIISPLATC R06AE

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

Identification

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

Packs · 3

  • ndc11
    4122669214
    2 BOTTLE in 1 CARTON (41226-692-14) / 70 TABLET, FILM COATED in 1 BOTTLE
  • ndc11
    4122669265
    1 BOTTLE in 1 CARTON (41226-692-65) / 365 TABLET, FILM COATED in 1 BOTTLE
  • ndc11
    4122669270
    1 BOTTLE in 1 CARTON (41226-692-70) / 70 TABLET, FILM COATED in 1 BOTTLE

Annotations

UNII (FDA Substance ID)
64O047KTOA
CETIRIZINE HYDROCHLORIDE
RxCUI 203150
Orange Book
A078933
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": {
    "934c7b91-3cba-47f0-8efa-77216f3f15c4": {
      "match": "brand_token",
      "title": "ALLERGY RELIEF CHILDRENS (DIPHENHYDRAMINE HCL) TABLET, CHEWABLE [AMERISOURCE BERGEN]",
      "spl_version": "14",
      "published_date": "2026-06-01"
    }
  },
  "productid": "41226-692_3e7fad54-62e1-6d0a-e063-6394a90a5785",
  "productndc": "41226-692",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "078933",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "5MG",
        "product_no": "001",
        "approval_date": "Jun 15, 2010"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "10MG",
        "product_no": "002",
        "approval_date": "Jun 15, 2010"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "5MG",
        "product_no": "003",
        "approval_date": "Jun 15, 2010"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "10MG",
        "product_no": "004",
        "approval_date": "Jun 15, 2010"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "CETIRIZINE HYDROCHLORIDE",
  "proprietary_name": "ALLERGY",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA078933",
  "marketing_category": "ANDA",
  "nonproprietary_name": "CETIRIZINE HYDROCHLORIDE",
  "start_marketing_date": "20210511",
  "active_numerator_strength": "10"
}

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