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United States · US · US:0536-1448_bc786388-cb4d-4210-9124-39a4bcbb7d38

rugby omeprazole

In shortageOrange BookUNIISPLATC A02BC01

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

Identification

ManufacturerRugby Laboratories
CountryUS (United States)
ATC codeA02BC01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    0536144813
    3 BOTTLE in 1 CARTON (0536-1448-13) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE
  • ndc11
    0536144888
    1 BOTTLE in 1 CARTON (0536-1448-88) / 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": {
    "50c46cf5-3e64-9e0f-e063-6294a90a2317": {
      "match": "brand_token",
      "title": "RUGBY ANTIFUNGAL (TOLNAFTATE AEROSOL, POWDER) AEROSOL, SPRAY [RUGBY LABORATORIES]",
      "spl_version": "2",
      "published_date": "2026-05-20"
    }
  },
  "productid": "0536-1448_bc786388-cb4d-4210-9124-39a4bcbb7d38",
  "productndc": "0536-1448",
  "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": "rugby omeprazole",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA022032",
  "marketing_category": "NDA",
  "nonproprietary_name": "Omeprazole",
  "start_marketing_date": "20250415",
  "active_numerator_strength": "20"
}

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