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United States · US · US:41163-001_86987736-810a-4fda-93b9-2f62faf9e607

equaline heartburn prevention

Orange BookUNIISPLATC A02BA03

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

Identification

ManufacturerUnited Natural Foods, Inc. dba UNFI
CountryUS (United States)
ATC codeA02BA03
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    4116300102
    25 BLISTER PACK in 1 CARTON (41163-001-02) / 1 TABLET, FILM COATED in 1 BLISTER PACK
  • ndc11
    4116300171
    1 BOTTLE in 1 CARTON (41163-001-71) / 50 TABLET, FILM COATED in 1 BOTTLE

Annotations

UNII (FDA Substance ID)
5QZO15J2Z8
FAMOTIDINE
RxCUI 4278
Orange Book
A077351
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "5QZO15J2Z8",
    "rxcui": "4278",
    "inchikey": "XUFQPHANEAPEMJ-UHFFFAOYSA-N",
    "display_name": "FAMOTIDINE",
    "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": "41163-001_86987736-810a-4fda-93b9-2f62faf9e607",
  "productndc": "41163-001",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "077351",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "20MG",
        "product_no": "001",
        "approval_date": "Sep 25, 2006"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "FAMOTIDINE",
  "proprietary_name": "equaline heartburn prevention",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA077351",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Famotidine",
  "start_marketing_date": "20141205",
  "active_numerator_strength": "20"
}

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