Omeprazole

In shortageOrange BookUNIISPLATC A02BC01

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerPreferred Pharmaceuticals Inc.

CountryUS (United States)

ATC codeA02BC01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 7

ndc11
6878888641
100 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68788-8864-1)
ndc11
6878888642
20 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68788-8864-2)
ndc11
6878888643
30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68788-8864-3)
ndc11
6878888644
14 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68788-8864-4)
ndc11
6878888646
60 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68788-8864-6)
ndc11
6878888648
120 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68788-8864-8)
ndc11
6878888649
90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68788-8864-9)

Annotations

UNII (FDA Substance ID)

KG60484QX9

OMEPRAZOLE

RxCUI 7646

Orange Book

A075757

ABAB

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": "68788-8864_0fb314cb-6291-422c-98ff-24d8449992f6",
  "productndc": "68788-8864",
  "dosage_form": "CAPSULE, DELAYED RELEASE",
  "orange_book": {
    "appl_no": "075757",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "10MG",
        "product_no": "001",
        "approval_date": "Jan 28, 2003"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "20MG",
        "product_no": "002",
        "approval_date": "Jan 28, 2003"
      }
    ],
    "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": "ANDA075757",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Omeprazole",
  "start_marketing_date": "20250423",
  "active_numerator_strength": "20"
}

Related drugs

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