Omeprazole

In shortageOrange BookUNIISPLATC A02BC01

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

Identification

ManufacturerSun Pharmaceutical Industries, Inc.

CountryUS (United States)

ATC codeA02BC01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 6

ndc11
6275637711
2 BOTTLE in 1 CARTON (62756-377-11) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE
ndc11
6275637712
3 BOTTLE in 1 CARTON (62756-377-12) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE
ndc11
6275637721
1 BOTTLE in 1 CARTON (62756-377-21) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE
ndc11
6275637770
1 BLISTER PACK in 1 CARTON (62756-377-70) / 14 TABLET, DELAYED RELEASE in 1 BLISTER PACK
ndc11
6275637779
3 BLISTER PACK in 1 CARTON (62756-377-79) / 14 TABLET, DELAYED RELEASE in 1 BLISTER PACK
ndc11
6275637796
2 BLISTER PACK in 1 CARTON (62756-377-96) / 14 TABLET, DELAYED RELEASE in 1 BLISTER PACK

Annotations

UNII (FDA Substance ID)

KG60484QX9

OMEPRAZOLE

RxCUI 7646

Orange Book

A207891

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": "62756-377_676e2f39-d83e-485a-9366-ed14c382e466",
  "productndc": "62756-377",
  "dosage_form": "TABLET, DELAYED RELEASE",
  "orange_book": {
    "appl_no": "207891",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "20MG",
        "product_no": "001",
        "approval_date": "Oct 12, 2018"
      }
    ],
    "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": "ANDA207891",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Omeprazole",
  "start_marketing_date": "20190101",
  "active_numerator_strength": "20"
}

Related drugs

Other records sharing ATC code A02BC01.

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