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United States · US · US:70000-0723_01e166d4-7ac5-421f-87d2-7b647631bf8d

leader omeprazole

In shortageOrange BookUNIISPLATC A02BC01

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

Identification

ManufacturerCardinal Health 110, LLC. dba Leader
CountryUS (United States)
ATC codeA02BC01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 3

  • ndc11
    7000007231
    1 BOTTLE in 1 CARTON (70000-0723-1) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE
  • ndc11
    7000007232
    14 BLISTER PACK in 1 CARTON (70000-0723-2) / 14 TABLET, DELAYED RELEASE in 1 BLISTER PACK
  • ndc11
    7000007233
    3 BOTTLE in 1 CARTON (70000-0723-3) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE

Annotations

UNII (FDA Substance ID)
KG60484QX9
OMEPRAZOLE
RxCUI 7646
Orange Book
N022032
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": {
    "12971fb2-2314-4443-bf70-b7eb5859b148": {
      "match": "brand_token",
      "title": "LEADER MUCUS RELIEF D (GUAIFENESIN, PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, MULTILAYER, EXTENDED RELEASE [CARDINAL HEALTH 110, LLC. DBA LEADER]",
      "spl_version": "3",
      "published_date": "2026-06-01"
    }
  },
  "productid": "70000-0723_01e166d4-7ac5-421f-87d2-7b647631bf8d",
  "productndc": "70000-0723",
  "dosage_form": "TABLET, DELAYED RELEASE",
  "orange_book": {
    "appl_no": "022032",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "20MG",
        "product_no": "001",
        "approval_date": "Dec 4, 2007"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "OMEPRAZOLE",
  "shortage_reason": "Omeprazole Delayed Release Capsule",
  "shortage_status": "current",
  "proprietary_name": "leader omeprazole",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA022032",
  "marketing_category": "NDA",
  "nonproprietary_name": "Omeprazole",
  "start_marketing_date": "20250416",
  "active_numerator_strength": "20"
}

Related drugs

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