Omeprazole

In shortageOrange BookUNIISPLATC A02BC01

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

Identification

ManufacturerAurobindo Pharma Limited

CountryUS (United States)

ATC codeA02BC01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 5

ndc11
5965100101
100 CAPSULE, DELAYED RELEASE in 1 BOTTLE (59651-001-01)
ndc11
5965100103
3 BLISTER PACK in 1 CARTON (59651-001-03) / 10 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK (59651-001-10)
ndc11
5965100130
30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (59651-001-30)
ndc11
5965100178
10 BLISTER PACK in 1 CARTON (59651-001-78) / 10 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK (59651-001-10)
ndc11
5965100199
1000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (59651-001-99)

Annotations

UNII (FDA Substance ID)

KG60484QX9

OMEPRAZOLE

RxCUI 7646

Orange Book

A203270

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": "59651-001_4cc78adf-d6a3-47b6-bc25-9d3f28d2a27a",
  "productndc": "59651-001",
  "dosage_form": "CAPSULE, DELAYED RELEASE",
  "orange_book": {
    "appl_no": "203270",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "10MG",
        "product_no": "001",
        "approval_date": "Aug 19, 2015"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "20MG",
        "product_no": "002",
        "approval_date": "Aug 19, 2015"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "40MG",
        "product_no": "003",
        "approval_date": "Aug 19, 2015"
      }
    ],
    "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": "ANDA203270",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Omeprazole",
  "start_marketing_date": "20150819",
  "active_numerator_strength": "10"
}

Related drugs

Other records sharing ATC code A02BC01.

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