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United States · US · US:72657-129_9b19f466-3796-44b8-a637-092926c275f1
Cetirizine HCl
Orange BookUNIISPLATC R06AE
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerGLENMARK THERAPEUTICS INC., USA
CountryUS (United States)
ATC codeR06AE
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 18
- ndc1172657129031 BOTTLE in 1 CARTON (72657-129-03) / 300 TABLET in 1 BOTTLE
- ndc1172657129041 BOTTLE in 1 CARTON (72657-129-04) / 400 TABLET in 1 BOTTLE
- ndc1172657129081 BOTTLE in 1 CARTON (72657-129-08) / 120 TABLET in 1 BOTTLE
- ndc1172657129141 BOTTLE in 1 CARTON (72657-129-14) / 140 TABLET in 1 BOTTLE
- ndc1172657129151 BOTTLE in 1 CARTON (72657-129-15) / 150 TABLET in 1 BOTTLE
- ndc1172657129181 BOTTLE in 1 CARTON (72657-129-18) / 180 TABLET in 1 BOTTLE
- ndc1172657129241 BOTTLE in 1 CARTON (72657-129-24) / 240 TABLET in 1 BOTTLE
- ndc1172657129301 BOTTLE in 1 CARTON (72657-129-30) / 30 TABLET in 1 BOTTLE
- ndc1172657129351 BOTTLE in 1 CARTON (72657-129-35) / 365 TABLET in 1 BOTTLE
- ndc1172657129411 BOTTLE in 1 CARTON (72657-129-41) / 14 TABLET in 1 BOTTLE
- ndc1172657129451 BOTTLE in 1 CARTON (72657-129-45) / 45 TABLET in 1 BOTTLE
- ndc1172657129601 BOTTLE in 1 CARTON (72657-129-60) / 60 TABLET in 1 BOTTLE
- ndc1172657129701 BOTTLE in 1 CARTON (72657-129-70) / 70 TABLET in 1 BOTTLE
- ndc1172657129812 BOTTLE in 1 CARTON (72657-129-81) / 60 TABLET in 1 BOTTLE
- ndc1172657129822 BOTTLE in 1 CARTON (72657-129-82) / 70 TABLET in 1 BOTTLE
- ndc1172657129842 BOTTLE in 1 CARTON (72657-129-84) / 90 TABLET in 1 BOTTLE
- ndc1172657129862 BOTTLE in 1 CARTON (72657-129-86) / 120 TABLET in 1 BOTTLE
- ndc1172657129901 BOTTLE in 1 CARTON (72657-129-90) / 90 TABLET in 1 BOTTLE
Annotations
UNII (FDA Substance ID)
64O047KTOA
CETIRIZINE HYDROCHLORIDE
RxCUI 203150
Orange Book
A078427
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": {
"817d07cf-5e31-421f-9e95-943bae01f5b0": {
"match": "brand_token",
"title": "CETIRIZINE HYDROCHLORIDE TABLET, CHEWABLE [SANDOZ INC]",
"spl_version": "8",
"published_date": "2026-06-01"
}
},
"productid": "72657-129_9b19f466-3796-44b8-a637-092926c275f1",
"productndc": "72657-129",
"dosage_form": "TABLET",
"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": "CETIRIZINE HYDROCHLORIDE",
"proprietary_name": "Cetirizine HCl",
"active_ingred_unit": "mg/1",
"application_number": "ANDA078427",
"marketing_category": "ANDA",
"nonproprietary_name": "Cetirizine",
"start_marketing_date": "20240513",
"active_numerator_strength": "10"
}Related drugs
Other records sharing ATC code R06AE.
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