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United States · US · US:68391-300_8459c675-5144-445c-afdb-c09b445fc14b
berkley and jensen famotidine
Orange BookUNIISPLATC A02BA03
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerBJWC
CountryUS (United States)
ATC codeA02BA03
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc1168391300822 BOTTLE in 1 PACKAGE (68391-300-82) / 100 TABLET, FILM COATED in 1 BOTTLE
- ndc1168391300852 BOTTLE in 1 PACKAGE (68391-300-85) / 125 TABLET, FILM COATED in 1 BOTTLE (68391-300-05)
Annotations
UNII (FDA Substance ID)
5QZO15J2Z8
FAMOTIDINE
RxCUI 4278
Orange Book
A077351
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": {
"cda57e42-6106-46ee-82d1-479a692ee5bb": {
"match": "brand_token",
"title": "BERKLEY AND JENSEN IBUPROFEN (IBUPROFEN) TABLET, FILM COATED [BJWC]",
"spl_version": "9",
"published_date": "2026-05-25"
}
},
"productid": "68391-300_8459c675-5144-445c-afdb-c09b445fc14b",
"productndc": "68391-300",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "077351",
"products": [
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "20MG",
"product_no": "001",
"approval_date": "Sep 25, 2006"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN OTC DRUG",
"substance_name": "FAMOTIDINE",
"proprietary_name": "berkley and jensen famotidine",
"active_ingred_unit": "mg/1",
"application_number": "ANDA077351",
"marketing_category": "ANDA",
"nonproprietary_name": "Famotidine",
"start_marketing_date": "20131209",
"active_numerator_strength": "20"
}Related drugs
Other records sharing ATC code A02BA03.
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