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United States · US · US:69168-476_37309c28-8650-401e-9a39-6b52112e0baf

Omeprazole

In shortageOrange BookUNIISPLATC A02BC01

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

Identification

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

Packs · 4

  • ndc11
    6916847614
    1 BOTTLE in 1 CARTON (69168-476-14) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE
  • ndc11
    6916847615
    14 TABLET, DELAYED RELEASE in 1 BOTTLE (69168-476-15)
  • ndc11
    6916847642
    3 BOTTLE in 1 CARTON (69168-476-42) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE
  • ndc11
    6916847661
    1 BOTTLE in 1 CARTON (69168-476-61) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE

Annotations

UNII (FDA Substance ID)
KG60484QX9
OMEPRAZOLE
RxCUI 7646
Orange Book
A211732
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Omeprazole Delayed Release Capsule
Raw payload (JSON)
{
  "unii": {
    "unii": "KG60484QX9",
    "rxcui": "7646",
    "inchikey": "SUBDBMMJDZJVOS-UHFFFAOYSA-N",
    "display_name": "OMEPRAZOLE",
    "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": "69168-476_37309c28-8650-401e-9a39-6b52112e0baf",
  "productndc": "69168-476",
  "dosage_form": "TABLET, DELAYED RELEASE",
  "orange_book": {
    "appl_no": "211732",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "EQ 20MG BASE",
        "product_no": "001",
        "approval_date": "Mar 25, 2020"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "OMEPRAZOLE",
  "shortage_reason": "Omeprazole Delayed Release Capsule",
  "shortage_status": "current",
  "proprietary_name": "Omeprazole",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA211732",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Omeprazole",
  "start_marketing_date": "20250321",
  "active_numerator_strength": "20"
}

Related drugs

Other records sharing ATC code A02BC01.

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