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United States · US · US:84126-300_372926c4-480a-ac1e-e063-6394a90a5293

Prilosec OTC

In shortageOrange BookUNIISPLATC A02BC01

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

Identification

ManufacturerThe Procter & Gamble Manufacturing Company
CountryUS (United States)
ATC codeA02BC01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 3

  • ndc11
    8412630014
    1 BLISTER PACK in 1 CARTON (84126-300-14) / 14 TABLET, DELAYED RELEASE in 1 BLISTER PACK
  • ndc11
    8412630024
    2 BLISTER PACK in 1 CARTON (84126-300-24) / 14 TABLET, DELAYED RELEASE in 1 BLISTER PACK
  • ndc11
    8412630042
    3 BLISTER PACK in 1 CARTON (84126-300-42) / 14 TABLET, DELAYED RELEASE in 1 BLISTER PACK

Annotations

UNII (FDA Substance ID)
426QFE7XLK
OMEPRAZOLE MAGNESIUM
RxCUI 236486
Orange Book
A206582
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Omeprazole Delayed Release Capsule
Raw payload (JSON)
{
  "unii": {
    "unii": "426QFE7XLK",
    "rxcui": "236486",
    "inchikey": "KWORUUGOSLYAGD-UHFFFAOYSA-N",
    "display_name": "OMEPRAZOLE MAGNESIUM",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "77ed80a2-a482-4838-ac55-4865b5c31d9f": {
      "match": "brand_token",
      "title": "PRILOSEC OTC (OMEPRAZOLE MAGNESIUM) TABLET, DELAYED RELEASE [THE PROCTER & GAMBLE MANUFACTURING COMPANY]",
      "spl_version": "16",
      "published_date": "2025-10-03"
    }
  },
  "productid": "84126-300_372926c4-480a-ac1e-e063-6394a90a5293",
  "productndc": "84126-300",
  "dosage_form": "TABLET, DELAYED RELEASE",
  "orange_book": {
    "appl_no": "206582",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "EQ 20MG BASE",
        "product_no": "001",
        "approval_date": "Jun 1, 2020"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "OMEPRAZOLE MAGNESIUM",
  "shortage_reason": "Omeprazole Delayed Release Capsule",
  "shortage_status": "current",
  "proprietary_name": "Prilosec OTC",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA206582",
  "marketing_category": "ANDA",
  "nonproprietary_name": "OMEPRAZOLE MAGNESIUM",
  "start_marketing_date": "20250901",
  "active_numerator_strength": "20.6"
}

Related drugs

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