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United States · US · US:53209-4001_37e8dec7-0fdb-a2b0-e063-6394a90abfc8
Pepcid Complete
In shortageOrange BookUNIISPLATC A02BA
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerMorning Star OTC
CountryUS (United States)
ATC codeA02BA
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11532094001225 BLISTER PACK in 1 PACKET (53209-4001-2) / 1 TABLET, CHEWABLE in 1 BLISTER PACK (53209-4001-1)
Annotations
UNII (FDA Substance ID)
H0G9379FGK
CALCIUM CARBONATE
RxCUI 1897
Orange Book
N020958
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Calcium Chloride Injection
Raw payload (JSON)
{
"unii": {
"unii": "H0G9379FGK",
"rxcui": "1897",
"inchikey": "VTYYLEPIZMXCLO-UHFFFAOYSA-L",
"display_name": "CALCIUM CARBONATE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"e874118f-b4fe-4c80-aece-99ea20e7e805": {
"match": "brand_token",
"title": "PEPCID COMPLETE (FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE) TABLET, CHEWABLE [KENVUE BRANDS LLC]",
"spl_version": "25",
"published_date": "2026-03-26"
}
},
"productid": "53209-4001_37e8dec7-0fdb-a2b0-e063-6394a90abfc8",
"productndc": "53209-4001",
"dosage_form": "TABLET, CHEWABLE",
"orange_book": {
"appl_no": "020958",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "800MG;10MG;165MG",
"product_no": "001",
"approval_date": "Oct 16, 2000"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN OTC DRUG",
"substance_name": "CALCIUM CARBONATE; FAMOTIDINE; MAGNESIUM HYDROXIDE",
"shortage_reason": "Calcium Chloride Injection",
"shortage_status": "current",
"proprietary_name": "Pepcid Complete",
"active_ingred_unit": "mg/1; mg/1; mg/1",
"application_number": "NDA020958",
"marketing_category": "NDA",
"nonproprietary_name": "Famotidine, Calcium carbonate, and Magnesium hydroxide",
"start_marketing_date": "20250619",
"active_numerator_strength": "800; 10; 165"
}Related drugs
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