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United States · US · US:41226-719_1cb86ee4-41c1-1196-e063-6394a90a9199
Original strength heartburn prevention
Orange BookUNIISPLATC A02BA03
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerKROGER COMPANY
CountryUS (United States)
ATC codeA02BA03
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc1141226719063 BLISTER PACK in 1 CARTON (41226-719-06) / 10 TABLET in 1 BLISTER PACK
- ndc1141226719091 BOTTLE in 1 CARTON (41226-719-09) / 90 TABLET in 1 BOTTLE
Annotations
UNII (FDA Substance ID)
5QZO15J2Z8
FAMOTIDINE
RxCUI 4278
Orange Book
A217543
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": {
"6695a3fb-b6c2-4752-a86f-d021fb558458": {
"match": "brand_token",
"title": "ORIGINAL ANTISEPTIC (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) MOUTHWASH [PUBLIX SUPER MARKETS, INC.]",
"spl_version": "17",
"published_date": "2026-04-15"
}
},
"productid": "41226-719_1cb86ee4-41c1-1196-e063-6394a90a9199",
"productndc": "41226-719",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "217543",
"products": [
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "10MG",
"product_no": "001",
"approval_date": "Mar 8, 2023"
},
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "20MG",
"product_no": "002",
"approval_date": "Mar 8, 2023"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN OTC DRUG",
"substance_name": "FAMOTIDINE",
"proprietary_name": "Original strength heartburn prevention",
"active_ingred_unit": "mg/1",
"application_number": "ANDA217543",
"marketing_category": "ANDA",
"nonproprietary_name": "Famotidine",
"start_marketing_date": "20230505",
"active_numerator_strength": "10"
}Related drugs
Other records sharing ATC code A02BA03.
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