Omeprazole delayed release

In shortageOrange BookUNIISPLATC A02BC01

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

Identification

ManufacturerTIME CAP LABORATORIES, INC.

CountryUS (United States)

ATC codeA02BC01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
4948373141
3 BOTTLE in 1 CARTON (49483-731-41) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE (49483-731-45)

Annotations

UNII (FDA Substance ID)

426QFE7XLK

OMEPRAZOLE MAGNESIUM

RxCUI 236486

Orange Book

A218829

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": {
    "b3ec4a44-5643-4438-b41b-e04946436719": {
      "match": "brand_token",
      "title": "OMEPRAZOLE CAPSULE, DELAYED RELEASE [SAFEWAY]",
      "spl_version": "3",
      "published_date": "2026-05-29"
    }
  },
  "productid": "49483-731_442e2a90-4ac6-8adf-e063-6394a90a6fc2",
  "productndc": "49483-731",
  "dosage_form": "TABLET, DELAYED RELEASE",
  "orange_book": {
    "appl_no": "218829",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "EQ 20MG BASE",
        "product_no": "001",
        "approval_date": "Aug 7, 2025"
      }
    ],
    "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": "Omeprazole delayed release",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA218829",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Omeprazole 20mg",
  "start_marketing_date": "20251215",
  "active_numerator_strength": "20"
}

Related drugs

Other records sharing ATC code A02BC01.

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