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United States · US · US:68196-121_e318316a-bbad-4640-9388-ccb3ce3d2cc0

members mark acid pep

Orange BookUNIISPLATC A02BA03

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

Identification

ManufacturerSam's West Inc
CountryUS (United States)
ATC codeA02BA03
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    6819612100
    2 BOTTLE in 1 CARTON (68196-121-00) / 100 TABLET, FILM COATED in 1 BOTTLE (68196-121-78)

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": {
    "69adad06-48f7-40d5-bca1-ae8e50ab1646": {
      "match": "brand_token",
      "title": "MEMBERS MARK NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [SAM'S WEST INC]",
      "spl_version": "5",
      "published_date": "2026-04-20"
    }
  },
  "productid": "68196-121_e318316a-bbad-4640-9388-ccb3ce3d2cc0",
  "productndc": "68196-121",
  "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": "members mark acid pep",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA077351",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Famotidine",
  "start_marketing_date": "20200504",
  "active_numerator_strength": "20"
}

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