Prilosec

In shortageOrange BookUNIISPLATC A02BC01

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

Identification

ManufacturerCovis Pharma US, Inc

CountryUS (United States)

ATC codeA02BC01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
7051562501
30 GRANULE, DELAYED RELEASE in 1 CARTON (70515-625-01)

Annotations

UNII (FDA Substance ID)

426QFE7XLK

OMEPRAZOLE MAGNESIUM

RxCUI 236486

Orange Book

N022056

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": "70515-625_296db0e8-af6e-4053-874d-2a7c8f7aba50",
  "productndc": "70515-625",
  "dosage_form": "GRANULE, DELAYED RELEASE",
  "orange_book": {
    "appl_no": "022056",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "EQ 2.5MG BASE/PACKET",
        "product_no": "001",
        "approval_date": "Mar 20, 2008"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "EQ 10MG BASE/PACKET",
        "product_no": "002",
        "approval_date": "Mar 20, 2008"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "OMEPRAZOLE MAGNESIUM",
  "shortage_reason": "Omeprazole Delayed Release Capsule",
  "shortage_status": "current",
  "proprietary_name": "Prilosec",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA022056",
  "marketing_category": "NDA",
  "nonproprietary_name": "omeprazole magnesium",
  "start_marketing_date": "20170825",
  "active_numerator_strength": "2.5"
}

Related drugs

Other records sharing ATC code A02BC01.

Access this data programmatically

Query Prilosec and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.

Get a free API key Read the API docs