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United States · US · US:16837-889_21af4ff4-5892-565e-e063-6394a90aa728
Maximum Strength PEPCID AC
Orange BookUNIISPLATC A02BA03
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerKenvue Brands LLC
CountryUS (United States)
ATC codeA02BA03
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc1116837889201 BOTTLE in 1 CARTON (16837-889-20) / 20 TABLET, FILM COATED in 1 BOTTLE
- ndc1116837889401 BOTTLE in 1 CARTON (16837-889-40) / 40 TABLET, FILM COATED in 1 BOTTLE
Annotations
UNII (FDA Substance ID)
5QZO15J2Z8
FAMOTIDINE
RxCUI 4278
Orange Book
N020325
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": {
"350764de-7801-b24e-e063-6394a90ab3c3": {
"match": "brand_token",
"title": "MAXIMUM STRENGTH MUCINEX SINUS-MAX PRESSURE, PAIN AND COUGH (ACETAMINOPHEN, GUAIFENESIN) TABLET, FILM COATED [RECKITT BENCKISER LLC]",
"spl_version": "2",
"published_date": "2026-05-15"
}
},
"productid": "16837-889_21af4ff4-5892-565e-e063-6394a90aa728",
"productndc": "16837-889",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "020325",
"products": [
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "10MG",
"product_no": "001",
"approval_date": "Apr 28, 1995"
},
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "20MG",
"product_no": "002",
"approval_date": "Sep 23, 2003"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN OTC DRUG",
"substance_name": "FAMOTIDINE",
"proprietary_name": "Maximum Strength PEPCID AC",
"active_ingred_unit": "mg/1",
"application_number": "NDA020325",
"marketing_category": "NDA",
"nonproprietary_name": "Famotidine",
"start_marketing_date": "20240311",
"active_numerator_strength": "20"
}Related drugs
Other records sharing ATC code A02BA03.
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