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United States · US · US:41167-0364_a185b361-cf81-4912-8020-d8f778903597

Zantac 360 Cool Mint

Orange BookUNIISPLATC A02BA03

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

Identification

ManufacturerChattem, Inc.
CountryUS (United States)
ATC codeA02BA03
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    4116703640
    1 BOTTLE in 1 CARTON (41167-0364-0) / 25 TABLET, FILM COATED in 1 BOTTLE

Annotations

UNII (FDA Substance ID)
5QZO15J2Z8
FAMOTIDINE
RxCUI 4278
Orange Book
A206531
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": {
    "19fe7c6e-243c-4005-a63a-f8cac1ce55c8": {
      "match": "brand_token",
      "title": "ZANTAC 360 COOL MINT (FAMOTIDINE) TABLET, FILM COATED [CHATTEM, INC.]",
      "spl_version": "4",
      "published_date": "2025-09-01"
    }
  },
  "productid": "41167-0364_a185b361-cf81-4912-8020-d8f778903597",
  "productndc": "41167-0364",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "206531",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "10MG",
        "product_no": "001",
        "approval_date": "Apr 26, 2016"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "20MG",
        "product_no": "002",
        "approval_date": "Apr 26, 2016"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "FAMOTIDINE",
  "proprietary_name": "Zantac 360 Cool Mint",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA206531",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Famotidine",
  "start_marketing_date": "20221201",
  "active_numerator_strength": "20"
}

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