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
6878888051
100 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68788-8805-1)
ndc11
6878888052
20 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68788-8805-2)
ndc11
6878888053
30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68788-8805-3)
ndc11
6878888054
14 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68788-8805-4)
ndc11
6878888056
60 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68788-8805-6)
ndc11
6878888057
120 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68788-8805-7)
ndc11
6878888059
90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68788-8805-9)

Annotations

UNII (FDA Substance ID)

KG60484QX9

OMEPRAZOLE

RxCUI 7646

Orange Book

A078490

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": "68788-8805_a806da8c-5f84-454d-966c-da1c48710f80",
  "productndc": "68788-8805",
  "dosage_form": "CAPSULE, DELAYED RELEASE",
  "orange_book": {
    "appl_no": "078490",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "40MG",
        "product_no": "001",
        "approval_date": "Apr 17, 2009"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "10MG",
        "product_no": "002",
        "approval_date": "Mar 16, 2009"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "20MG",
        "product_no": "003",
        "approval_date": "Mar 16, 2009"
      }
    ],
    "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": "ANDA078490",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Omeprazole",
  "start_marketing_date": "20250120",
  "active_numerator_strength": "20"
}

Related drugs

Other records sharing ATC code A02BC01.

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