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United States · US · US:72189-237_15ac00f8-da4e-6cea-e063-6294a90aeb81
Meclizine Hydrochloride
Orange BookUNIISPLATC R06AE55
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerDirect_Rx
CountryUS (United States)
ATC codeR06AE55
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc11721892373030 TABLET in 1 BOTTLE (72189-237-30)
- ndc11721892379090 TABLET in 1 BOTTLE (72189-237-90)
Annotations
UNII (FDA Substance ID)
HDP7W44CIO
MECLIZINE HYDROCHLORIDE
RxCUI 82041
Orange Book
N010721
AAAAAA
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "HDP7W44CIO",
"rxcui": "82041",
"inchikey": "KDLHYOMCWBWLMM-UHFFFAOYSA-N",
"display_name": "MECLIZINE HYDROCHLORIDE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"52ee9258-8311-e6bd-e063-6294a90a567f": {
"match": "brand_token",
"title": "MECLIZINE HYDROCHLORIDE (MECLIZINE) TABLET [REDPHARM DRUG]",
"spl_version": "1",
"published_date": "2026-06-01"
}
},
"productid": "72189-237_15ac00f8-da4e-6cea-e063-6294a90aeb81",
"productndc": "72189-237",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "010721",
"products": [
{
"rs": true,
"rld": true,
"te_code": "AA",
"strength": "50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",
"product_no": "001",
"approval_date": "Jan 20, 1982"
},
{
"rs": false,
"rld": true,
"te_code": "AA",
"strength": "25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",
"product_no": "004",
"approval_date": "Approved Prior to Jan 1, 1982"
},
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",
"product_no": "005",
"approval_date": "Approved Prior to Jan 1, 1982"
},
{
"rs": false,
"rld": true,
"te_code": "AA",
"strength": "12.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",
"product_no": "006",
"approval_date": "Approved Prior to Jan 1, 1982"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "MECLIZINE HYDROCHLORIDE",
"proprietary_name": "Meclizine Hydrochloride",
"active_ingred_unit": "mg/1",
"application_number": "NDA010721",
"marketing_category": "NDA AUTHORIZED GENERIC",
"nonproprietary_name": "Meclizine Hydrochloride",
"start_marketing_date": "20220901",
"active_numerator_strength": "25"
}Related drugs
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