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United States · US · US:68788-8518_a58e51a0-5e60-4a69-aaea-4b741826c372
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
- ndc11687888518330 TABLET, FILM COATED in 1 BOTTLE (68788-8518-3)
- ndc11687888518414 TABLET, FILM COATED in 1 BOTTLE (68788-8518-4)
- ndc11687888518660 TABLET, FILM COATED in 1 BOTTLE (68788-8518-6)
- ndc11687888518990 TABLET, FILM COATED in 1 BOTTLE (68788-8518-9)
Annotations
UNII (FDA Substance ID)
5QZO15J2Z8
FAMOTIDINE
RxCUI 4278
Orange Book
A215630
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": "68788-8518_a58e51a0-5e60-4a69-aaea-4b741826c372",
"productndc": "68788-8518",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "215630",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "20MG",
"product_no": "001",
"approval_date": "Jan 7, 2022"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "40MG",
"product_no": "002",
"approval_date": "Jan 7, 2022"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "FAMOTIDINE",
"proprietary_name": "FAMOTIDINE",
"active_ingred_unit": "mg/1",
"application_number": "ANDA215630",
"marketing_category": "ANDA",
"nonproprietary_name": "FAMOTIDINE",
"start_marketing_date": "20230901",
"active_numerator_strength": "40"
}Related drugs
Other records sharing ATC code A02BA03.
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