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United States · US · US:68788-4021_6edbd842-cf86-48a5-bc22-967620a2b5cb
Famotidine
Orange BookUNIISPLATC A02BA03
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerPreferred Pharmaceuticals Inc.
CountryUS (United States)
ATC codeA02BA03
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 4
- ndc11687884021330 TABLET, FILM COATED in 1 BOTTLE (68788-4021-3)
- ndc11687884021414 TABLET, FILM COATED in 1 BOTTLE (68788-4021-4)
- ndc11687884021660 TABLET, FILM COATED in 1 BOTTLE (68788-4021-6)
- ndc11687884021990 TABLET, FILM COATED in 1 BOTTLE (68788-4021-9)
Annotations
UNII (FDA Substance ID)
5QZO15J2Z8
FAMOTIDINE
RxCUI 4278
Orange Book
A217400
ABAB
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": {
"e53928f3-5181-490b-acfb-be8d4cea60a9": {
"match": "brand_token",
"title": "FAMOTIDINE TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]",
"spl_version": "1",
"published_date": "2026-06-01"
}
},
"productid": "68788-4021_6edbd842-cf86-48a5-bc22-967620a2b5cb",
"productndc": "68788-4021",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "217400",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "20MG",
"product_no": "001",
"approval_date": "Aug 6, 2024"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "40MG",
"product_no": "002",
"approval_date": "Aug 6, 2024"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "FAMOTIDINE",
"proprietary_name": "Famotidine",
"active_ingred_unit": "mg/1",
"application_number": "ANDA217400",
"marketing_category": "ANDA",
"nonproprietary_name": "Famotidine",
"start_marketing_date": "20250905",
"active_numerator_strength": "20"
}Related drugs
Other records sharing ATC code A02BA03.
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