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United States · US · US:43063-743_414b3f69-cc8c-44cb-e063-6394a90a8d5a

Omeprazole

In shortageOrange BookUNIISPLATC A02BC01

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerPD-Rx Pharmaceuticals, Inc.
CountryUS (United States)
ATC codeA02BC01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 4

  • ndc11
    4306374314
    14 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC (43063-743-14)
  • ndc11
    4306374330
    30 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC (43063-743-30)
  • ndc11
    4306374360
    60 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC (43063-743-60)
  • ndc11
    4306374390
    90 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC (43063-743-90)

Annotations

UNII (FDA Substance ID)
KG60484QX9
OMEPRAZOLE
RxCUI 7646
Orange Book
A075576
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": "43063-743_414b3f69-cc8c-44cb-e063-6394a90a8d5a",
  "productndc": "43063-743",
  "dosage_form": "CAPSULE, DELAYED RELEASE",
  "orange_book": {
    "appl_no": "075576",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "40MG",
        "product_no": "001",
        "approval_date": "Jan 21, 2009"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "20MG",
        "product_no": "002",
        "approval_date": "Oct 22, 2007"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "10MG",
        "product_no": "003",
        "approval_date": "Oct 22, 2007"
      }
    ],
    "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": "ANDA075576",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Omeprazole",
  "start_marketing_date": "20090121",
  "active_numerator_strength": "20"
}

Related drugs

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