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United States · US · US:0378-2895_8e8396fa-288b-402e-82b0-b1007d1b571f
Ferric Citrate
Orange BookUNIISPL
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerMylan Pharmaceuticals Inc.
CountryUS (United States)
ATC code—
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc110378289520200 TABLET, FILM COATED in 1 BOTTLE (0378-2895-20)
Annotations
UNII (FDA Substance ID)
Q91187K011
TETRAFERRIC TRICITRATE DECAHYDRATE
Orange Book
N205874
AB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "Q91187K011",
"rxcui": null,
"inchikey": "UISKQNNAQKPSDO-UHFFFAOYSA-E",
"display_name": "TETRAFERRIC TRICITRATE DECAHYDRATE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"314bd2e4-2ca5-4e2a-9fea-13373f910f34": {
"match": "brand_token",
"title": "FERRIC CITRATE TABLET, FILM COATED [TEVA PHARMACEUTICALS, INC.]",
"spl_version": "1",
"published_date": "2026-03-12"
}
},
"productid": "0378-2895_8e8396fa-288b-402e-82b0-b1007d1b571f",
"productndc": "0378-2895",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "205874",
"products": [
{
"rs": true,
"rld": true,
"te_code": "AB",
"strength": "EQ 210MG IRON",
"product_no": "001",
"approval_date": "Sep 5, 2014"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "TETRAFERRIC TRICITRATE DECAHYDRATE",
"proprietary_name": "Ferric Citrate",
"active_ingred_unit": "mg/1",
"application_number": "NDA205874",
"marketing_category": "NDA AUTHORIZED GENERIC",
"nonproprietary_name": "Ferric Citrate",
"start_marketing_date": "20250320",
"active_numerator_strength": "210"
}Access this data programmatically
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