Back to search
🇺🇸

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

  • ndc11
    8072524330
    30 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        "strength": "10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",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.

Access this data programmatically

Query Aciphex and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.