Zantac 360

Orange BookUNIISPLATC A02BA03

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

Identification

ManufacturerChattem, Inc.

CountryUS (United States)

ATC codeA02BA03

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 7

ndc11
4116703610
1 BLISTER PACK in 1 CARTON (41167-0361-0) / 8 TABLET, FILM COATED in 1 BLISTER PACK
ndc11
4116703611
1 BLISTER PACK in 1 CARTON (41167-0361-1) / 1 TABLET, FILM COATED in 1 BLISTER PACK
ndc11
4116703612
1 BOTTLE in 1 CARTON (41167-0361-2) / 25 TABLET, FILM COATED in 1 BOTTLE
ndc11
4116703614
1 BOTTLE in 1 CARTON (41167-0361-4) / 50 TABLET, FILM COATED in 1 BOTTLE
ndc11
4116703616
1 BOTTLE in 1 CARTON (41167-0361-6) / 90 TABLET, FILM COATED in 1 BOTTLE
ndc11
4116703618
1 BOTTLE in 1 CARTON (41167-0361-8) / 100 TABLET, FILM COATED in 1 BOTTLE
ndc11
4116703619
2 BOTTLE in 1 CELLO PACK (41167-0361-9) / 70 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": "41167-0361_efcd0b2f-86c9-43c6-889f-7962e191a9cb",
  "productndc": "41167-0361",
  "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",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA206531",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Famotidine",
  "start_marketing_date": "20210412",
  "active_numerator_strength": "20"
}

Related drugs

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