equaline omeprazole

In shortageOrange BookUNIISPLATC A02BC01

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

Identification

ManufacturerUnited Natural Foods, Inc. dba UNFI

CountryUS (United States)

ATC codeA02BC01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
4116363474
14 BLISTER PACK in 1 CARTON (41163-634-74) / 1 TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE in 1 BLISTER PACK

Annotations

UNII (FDA Substance ID)

KG60484QX9

OMEPRAZOLE

RxCUI 7646

Orange Book

N209400

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": {
    "8fc2389c-9657-4dbe-a32b-df8245fc67ca": {
      "match": "brand_token",
      "title": "EQUALINE DAYTIME AND NIGHTTIME COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [UNITED NATURAL FOODS, INC. DBA UNFI]",
      "spl_version": "10",
      "published_date": "2026-05-21"
    }
  },
  "productid": "41163-634_d806739f-7f7b-42ae-af48-d1b0b22d3eef",
  "productndc": "41163-634",
  "dosage_form": "TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE",
  "orange_book": {
    "appl_no": "209400",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "20MG",
        "product_no": "001",
        "approval_date": "Jul 5, 2017"
      }
    ],
    "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": "equaline omeprazole",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA209400",
  "marketing_category": "NDA",
  "nonproprietary_name": "omeprazole",
  "start_marketing_date": "20181011",
  "active_numerator_strength": "20"
}

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