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United States · US · US:80725-243_cc6cb214-ac28-4c8b-9b57-7635ef896038
Aciphex
Orange BookUNIISPLATC A02BC04
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerWaylis Therapeutics LLC
CountryUS (United States)
ATC codeA02BC04
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11807252433030 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (80725-243-30)
Annotations
UNII (FDA Substance ID)
3L36P16U4R
RABEPRAZOLE SODIUM
RxCUI 226868
Orange Book
N020973
AB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "3L36P16U4R",
"rxcui": "226868",
"inchikey": "KRCQSTCYZUOBHN-UHFFFAOYSA-N",
"display_name": "RABEPRAZOLE SODIUM",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"1eb38279-0237-4967-be7a-c53a826c1138": {
"match": "brand_token",
"title": "ACIPHEX (RABEPRAZOLE SODIUM) TABLET, DELAYED RELEASE [WAYLIS THERAPEUTICS LLC]",
"spl_version": "3",
"published_date": "2026-01-30"
}
},
"productid": "80725-243_cc6cb214-ac28-4c8b-9b57-7635ef896038",
"productndc": "80725-243",
"dosage_form": "TABLET, DELAYED RELEASE",
"orange_book": {
"appl_no": "020973",
"products": [
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",
"product_no": "001",
"approval_date": "May 29, 2002"
},
{
"rs": true,
"rld": true,
"te_code": "AB",
"strength": "20MG",
"product_no": "002",
"approval_date": "Aug 19, 1999"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "RABEPRAZOLE SODIUM",
"proprietary_name": "Aciphex",
"active_ingred_unit": "mg/1",
"application_number": "NDA020973",
"marketing_category": "NDA",
"nonproprietary_name": "rabeprazole sodium",
"start_marketing_date": "20220515",
"active_numerator_strength": "20"
}Related drugs
Other records sharing ATC code A02BC04.
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