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United States · US · US:76420-878_2dfff480-dff9-b242-e063-6394a90a1fcf

Omeprazole

In shortageOrange BookUNIISPLATC A02BC01

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

Identification

ManufacturerAsclemed USA, Inc.
CountryUS (United States)
ATC codeA02BC01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 6

  • ndc11
    7642087800
    1000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (76420-878-00)
  • ndc11
    7642087801
    100 CAPSULE, DELAYED RELEASE in 1 BOTTLE (76420-878-01)
  • ndc11
    7642087803
    30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (76420-878-03)
  • ndc11
    7642087806
    60 CAPSULE, DELAYED RELEASE in 1 BOTTLE (76420-878-06)
  • ndc11
    7642087809
    90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (76420-878-09)
  • ndc11
    7642087812
    120 CAPSULE, DELAYED RELEASE in 1 BOTTLE (76420-878-12)

Annotations

UNII (FDA Substance ID)
KG60484QX9
OMEPRAZOLE
RxCUI 7646
Orange Book
A091672
ABABAB
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": "76420-878_2dfff480-dff9-b242-e063-6394a90a1fcf",
  "productndc": "76420-878",
  "dosage_form": "CAPSULE, DELAYED RELEASE",
  "orange_book": {
    "appl_no": "091672",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "10MG",
        "product_no": "001",
        "approval_date": "Oct 31, 2014"
      },
      {
        "rs": true,
        "rld": false,
        "te_code": "AB",
        "strength": "20MG",
        "product_no": "002",
        "approval_date": "Oct 31, 2014"
      },
      {
        "rs": true,
        "rld": false,
        "te_code": "AB",
        "strength": "40MG",
        "product_no": "003",
        "approval_date": "Oct 31, 2014"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "OMEPRAZOLE",
  "shortage_reason": "Omeprazole Delayed Release Capsule",
  "shortage_status": "current",
  "proprietary_name": "Omeprazole",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA091672",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Omeprazole",
  "start_marketing_date": "20141031",
  "active_numerator_strength": "10"
}

Related drugs

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