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United States · US · US:25000-086_c1fe0ae2-1d7b-409d-97cb-9e03eeb7f402
Famotidine 10 mg
Orange BookUNIISPLATC A02BA03
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerMARKSANS PHARMA LIMITED
CountryUS (United States)
ATC codeA02BA03
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 4
- ndc1125000086031 BOTTLE in 1 CARTON (25000-086-03) / 30 TABLET, COATED in 1 BOTTLE
- ndc1125000086071 BOTTLE in 1 CARTON (25000-086-07) / 90 TABLET, COATED in 1 BOTTLE
- ndc1125000086081 BOTTLE in 1 CARTON (25000-086-08) / 100 TABLET, COATED in 1 BOTTLE
- ndc1125000086363 BLISTER PACK in 1 CARTON (25000-086-36) / 10 TABLET, COATED in 1 BLISTER PACK
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": {
"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": "25000-086_c1fe0ae2-1d7b-409d-97cb-9e03eeb7f402",
"productndc": "25000-086",
"dosage_form": "TABLET, COATED",
"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": "Famotidine 10 mg",
"active_ingred_unit": "mg/1",
"application_number": "ANDA217543",
"marketing_category": "ANDA",
"nonproprietary_name": "Famotidine 10 mg",
"start_marketing_date": "20230310",
"active_numerator_strength": "10"
}Related drugs
Other records sharing ATC code A02BA03.
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