FDA.reportPublic FDA data

NDC 54092-252-45 - Fosrenol

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
54092-252
Requested NDC
54092-252-45
Package NDCs from labels
54092-252-45, 54092-252-90
Manufacturer
Takeda Pharmaceuticals America, Inc. | Patheon Manufacturing Services LLC | Element Materials Technology Pharma US LLC | Reading Scientific Services Ltd (RSSL) | Triclinic Labs | Microbac Laboratories, Inc. | Catalent Germany Schorndorf GmbH | BCM Ltd | Reckitt Benckiser Healthcare International Ltd.
Effective date
2024-12-31
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
FosrenolTakeda Pharmaceuticals America, Inc. | Patheon Manufacturing Services LLC | Element Materials Technology Pharma US LLC | Reading Scientific Services Ltd (RSSL) | Triclinic Labs | Microbac Laboratories, Inc. | Catalent Germany Schorndorf GmbH | BCM Ltd | Reckitt Benckiser Healthcare International Ltd.2024-12-31HUMAN PRESCRIPTION DRUG LABEL
National Council for Prescription Drug Programs indexing - billing unitNational Council for Prescription Drug Programs2012-07-24Indexing - Billing Unit

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54092-252-45Fosrenol45 in 1 BOTTLETABLET, CHEWABLE4558
54092-252-90Fosrenol2 in 1 PACKAGETABLET, CHEWABLE258

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54092-252FOSRENOL (LANTHANUM CARBONATE) TABLET, CHEWABLE FOSRENOL (LANTHANUM CARBONATE) POWDER [TAKEDA PHARMACEUTICALS AMERICA, INC.]58Current NDC, Legacy NDC, 2 package rows20250406_f10776b2-2c25-4343-aabe-68f302e5cb54.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
54092-252-45EA - Each54092-252b282d18a-0ea6-49f4-9604-90f1f1568bc412012-07-24
54092-252-90EA - Each54092-2523074ba73-ac12-4a1e-94f8-89da7eee738e12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LANTHANUM CARBONATEACTIVE INGREDIENT490D9F069TFOSRENOL (LANTHANUM CARBONATE) TABLET, CHEWABLE FOSRENOL (LANTHANUM CARBONATE) POWDER [SHIRE US MANUFACTURING INC.]39
LANTHANUM CATION (3+)ACTIVE MOIETYO7FU5X12W5FOSRENOL (LANTHANUM CARBONATE) TABLET, CHEWABLE FOSRENOL (LANTHANUM CARBONATE) POWDER [SHIRE US MANUFACTURING INC.]39
DEXTRATESINACTIVE INGREDIENTG263MI44RUFOSRENOL (LANTHANUM CARBONATE) TABLET, CHEWABLE FOSRENOL (LANTHANUM CARBONATE) POWDER [SHIRE US MANUFACTURING INC.]39
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30FOSRENOL (LANTHANUM CARBONATE) TABLET, CHEWABLE FOSRENOL (LANTHANUM CARBONATE) POWDER [SHIRE US MANUFACTURING INC.]39
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4FOSRENOL (LANTHANUM CARBONATE) TABLET, CHEWABLE FOSRENOL (LANTHANUM CARBONATE) POWDER [SHIRE US MANUFACTURING INC.]39

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 7 of 31 · 608 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Second Chakra (Sacral) 7302SECOND CHAKRA (SACRAL)Professional Complementary Health Formulasea8a69d3-66fc-4b21-bfdd-c207dd2935892026-01-08WarningsExact identifier
unii: ETJ7Z6XBU4
Silicea 8012SILICEAProfessional Complementary Health Formulasa2a1eae8-24c8-44dd-9b9d-1826fa7164332026-01-08WarningsExact identifier
unii: ETJ7Z6XBU4
Acne Drops 2001ACNE DROPSProfessional Complementary Health Formulas340fc7dc-2aa4-411f-842b-4ce7046717222026-01-08WarningsExact identifier
unii: ETJ7Z6XBU4
Travel Immunization Detox 6033TRAVEL IMMUNIZATION DETOXProfessional Complementary Health Formulasb74abfad-fe22-476c-9692-07d66cc15ac52026-01-08WarningsExact identifier
unii: ETJ7Z6XBU4
Thymus Drops 5027THYMUS DROPSProfessional Complementary Health Formulas8d7c42f7-02ae-4992-986f-4743151ad3bb2026-01-08WarningsExact identifier
unii: ETJ7Z6XBU4
Amalgam 6003AMALGAMProfessional Complementary Health Formulas1af74f69-a23a-45a2-a20e-92bf8b0ccb222026-01-08WarningsExact identifier
unii: ETJ7Z6XBU4
Rose Quartz 8142ROSE QUARTZProfessional Complementary Health Formulas898cd57d-8656-457d-92ff-5b4ea13578002026-01-08WarningsExact identifier
unii: ETJ7Z6XBU4
Pneumo Drops 5018PNEUMO DROPSProfessional Complementary Health Formulasea6d0286-db1c-48c0-83fd-c18fa8f8629f2026-01-08WarningsExact identifier
unii: ETJ7Z6XBU4
Difficulty Breathing Drops 2171DIFFICULTY BREATHING DROPSProfessional Complementary Health Formulas30bab475-47dd-4261-b497-1f8edf9dd4112026-01-08WarningsExact identifier
unii: ETJ7Z6XBU4
RET Spleen/Pancreas 7002RET SPLEEN/PANCREASProfessional Complementary Health Formulasc6c82d50-0650-4cd9-85b9-c3cd422a35ce2026-01-08WarningsExact identifier
unii: ETJ7Z6XBU4
Vaccinosis Nosode 4004VACCINOSIS NOSODEProfessional Complementary Health Formulasdff675b3-6330-45d0-984c-526a8f44202b2026-01-08WarningsExact identifier
unii: ETJ7Z6XBU4
Sinusitis Drops 2060SINUSITIS DROPSProfessional Complementary Health Formulas00469764-e0ab-45cf-8e61-6bdc67d31e542026-01-08WarningsExact identifier
unii: ETJ7Z6XBU4
Large Ring Combination 9302LARGE RING COMBINATIONProfessional Complementary Health Formulascced8a69-7bc0-42ad-b80a-58fc603bf7652026-01-08WarningsExact identifier
unii: ETJ7Z6XBU4
Domestic Animals Nosode Combination 9407DOMESTIC ANIMALS NOSODE COMBINATIONProfessional Complementary Health Formulas222c28aa-e07b-4706-9fb5-585b190f1c5b2026-01-08WarningsExact identifier
unii: ETJ7Z6XBU4
Cataract Drops 2085CATARACT DROPSProfessional Complementary Health Formulas6040a096-ccdb-4e1e-a242-be29c3127f272026-01-08WarningsExact identifier
unii: ETJ7Z6XBU4
RET Thyroid/Adrenal 7011RET THYROID/ADRENALProfessional Complementary Health Formulaseb313eb9-4dfc-402e-92b3-14f09f4ba8692026-01-08WarningsExact identifier
unii: ETJ7Z6XBU4
Lymph Stim Liquescence 3016LYMPH STIM LIQUESCENCEProfessional Complementary Health Formulasd91939ea-e3dc-49b1-949a-6618a4c4ae0d2026-01-08WarningsExact identifier
unii: ETJ7Z6XBU4
Nitrogen Combination 9310NITROGEN COMBINATIONProfessional Complementary Health Formulas72a7c0f3-0a57-4aa8-8fe8-a3267b9acd532026-01-08WarningsExact identifier
unii: ETJ7Z6XBU4
Psorinum Miasm Drops 2054PSORINUM MIASM DROPSProfessional Complementary Health Formulasa34aadab-b634-461f-a0ff-58f42f6e08332026-01-08WarningsExact identifier
unii: ETJ7Z6XBU4
Pneumonia/Meningitis Nosode Combination 9414PNEUMONIA/MENINGITIS NOSODE COMBINATIONProfessional Complementary Health Formulas823de3e3-4d20-446c-988d-d7a70a747f9a2026-01-08WarningsExact identifier
unii: ETJ7Z6XBU4

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.