Omeprazole Magnesium

In shortageOrange BookUNIISPLATC A02BC01

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

Identification

ManufacturerGericare Pharmaceuticals

CountryUS (United States)

ATC codeA02BC01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 3

ndc11
5789675914
1 BOTTLE in 1 CARTON (57896-759-14) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE
ndc11
5789675928
2 BOTTLE in 1 CARTON (57896-759-28) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE
ndc11
5789675942
3 BOTTLE in 1 CARTON (57896-759-42) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE

Annotations

UNII (FDA Substance ID)

426QFE7XLK

OMEPRAZOLE MAGNESIUM

RxCUI 236486

Orange Book

A078878

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": "57896-759_3b0207de-ac3b-e214-e063-6294a90a59fc",
  "productndc": "57896-759",
  "dosage_form": "CAPSULE, DELAYED RELEASE",
  "orange_book": {
    "appl_no": "078878",
    "products": [
      {
        "rs": true,
        "rld": false,
        "te_code": null,
        "strength": "EQ 20MG BASE",
        "product_no": "001",
        "approval_date": "Jun 5, 2009"
      }
    ],
    "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 Magnesium",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA078878",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Omeprazole Magnesium",
  "start_marketing_date": "20130401",
  "active_numerator_strength": "20.6"
}

Related drugs

Other records sharing ATC code A02BC01.

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