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United States · US · US:0363-6089_cc051c20-36b7-4eb6-95e5-65734ef65458

omeprazole

In shortageOrange BookUNIISPLATC A02BC01

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerWalgreen Company
CountryUS (United States)
ATC codeA02BC01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    0363608901
    14 CAPSULE, DELAYED RELEASE in 1 BOTTLE (0363-6089-01)
  • ndc11
    0363608903
    3 BOTTLE in 1 CARTON (0363-6089-03) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE

Annotations

UNII (FDA Substance ID)
426QFE7XLK
OMEPRAZOLE MAGNESIUM
RxCUI 236486
Orange Book
A216096
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Omeprazole Delayed Release Capsule
Raw payload (JSON)
{
  "unii": {
    "unii": "426QFE7XLK",
    "rxcui": "236486",
    "inchikey": "KWORUUGOSLYAGD-UHFFFAOYSA-N",
    "display_name": "OMEPRAZOLE MAGNESIUM",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "b3ec4a44-5643-4438-b41b-e04946436719": {
      "match": "brand_token",
      "title": "OMEPRAZOLE CAPSULE, DELAYED RELEASE [SAFEWAY]",
      "spl_version": "3",
      "published_date": "2026-05-29"
    }
  },
  "productid": "0363-6089_cc051c20-36b7-4eb6-95e5-65734ef65458",
  "productndc": "0363-6089",
  "dosage_form": "CAPSULE, DELAYED RELEASE",
  "orange_book": {
    "appl_no": "216096",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "EQ 20MG BASE",
        "product_no": "001",
        "approval_date": "May 24, 2022"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "OMEPRAZOLE MAGNESIUM",
  "shortage_reason": "Omeprazole Delayed Release Capsule",
  "shortage_status": "current",
  "proprietary_name": "omeprazole",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA216096",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Omeprazole magnesium",
  "start_marketing_date": "20240409",
  "active_numerator_strength": "20"
}

Related drugs

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