Cetirizine HCl

Orange BookSPL

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerGLENMARK THERAPEUTICS INC., USA

CountryUS (United States)

ATC code—

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
7265713005
1 KIT in 1 PACKAGE (72657-130-05) * 1 BOTTLE in 1 CARTON / 60 TABLET in 1 BOTTLE * 1 BOTTLE in 1 CARTON / 90 TABLET in 1 BOTTLE

Annotations

Orange Book

A078427

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "route": null,
  "spl_meta": {
    "817d07cf-5e31-421f-9e95-943bae01f5b0": {
      "match": "brand_token",
      "title": "CETIRIZINE HYDROCHLORIDE TABLET, CHEWABLE [SANDOZ INC]",
      "spl_version": "8",
      "published_date": "2026-06-01"
    }
  },
  "productid": "72657-130_9b19f466-3796-44b8-a637-092926c275f1",
  "productndc": "72657-130",
  "dosage_form": "KIT",
  "orange_book": {
    "appl_no": "078427",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "5MG",
        "product_no": "003",
        "approval_date": "Dec 28, 2007"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "10MG",
        "product_no": "004",
        "approval_date": "Dec 28, 2007"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": null,
  "proprietary_name": "Cetirizine HCl",
  "active_ingred_unit": null,
  "application_number": "ANDA078427",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Cetirizine",
  "start_marketing_date": "20240513",
  "active_numerator_strength": null
}

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