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 19 of 31 · 608 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
N-24METABOLINDNA Labs, Inc.559fca2b-1093-4bdf-be70-c453f87002c32025-01-09WarningsExact identifier
unii: ETJ7Z6XBU4
NO-WEAK-NAILSGRAPHITE, THUJA OCCIDENTALIS LEAFY TWIG, AND SILICON DIOXIDEMiers Laboratories9158cd3f-4c27-40e9-bc07-fd560375c3a12025-01-09WarningsExact identifier
unii: ETJ7Z6XBU4
Ferrum Silicicum UrticaFERRUM SILICICUM URTICAUriel Pharmacy Inc.09829ac4-c074-7315-e063-6394a90adf592025-01-07WarningsExact identifier
unii: ETJ7Z6XBU4
MIMIBO PREMIUM TOOTHSILICON DIOXIDE, TOCOPHEROL ACETATE, TETRASODIUM PYROPHOSPHATECONE MEDICAL Co., Ltd.c0ff5df4-0b37-0b1b-e053-2a95a90a862c2025-01-02WarningsExact identifier
unii: ETJ7Z6XBU4
MIMIBO PREMIUM TOOTHSILICON DIOXIDE, TOCOPHEROL ACETATE, TETRASODIUM PYROPHOSPHATECONE MEDICAL Co., Ltd.c101881a-5a12-2e04-e053-2a95a90a3f572025-01-02WarningsExact identifier
unii: ETJ7Z6XBU4
NativeRemedies Acid Free-FluxCALC PHOS 9X, CARBO VEG 6C, MAG CARB 6C, NAT PHOS 9X, SILICEA 9XSilver Star Brandsd5012b1f-861e-40b8-e053-2a95a90a4fe22025-01-01WarningsExact identifier
unii: ETJ7Z6XBU4
Mucus Clear Allergy ReliefALLIU CEPA, CALC PHOS, EUPHRASIA, IGNATIA, KALI MUR, NAT MUR, NUX VOM, PULSATILLA, SILICASilver Star Brandsf49bdcc1-1939-6dc2-e053-2995a90a0a3b2025-01-01WarningsExact identifier
unii: ETJ7Z6XBU4
NativeRemedies Gout-GoneANTIMON CRUD, BENZOICUM AC, LEDUM, NUX VOM, QUERCUS, RHODODENDRON, SILICEASilver Star Brandsf66b42f0-8f5f-1aca-e053-2a95a90ae3962025-01-01WarningsExact identifier
unii: ETJ7Z6XBU4
NeuropathEaseAGARICUS MUSC, ARSENICUM ALB, HYPERICUM, PHOS, SILICEASilver Star Brands7809e54a-018d-9cf6-e053-2a91aa0aedfe2025-01-01WarningsExact identifier
unii: ETJ7Z6XBU4
AllergiClear-MADRENALINUM, CALCAREA FLUORICA, CALCAREA PHOSPHORICA, EUPHRASIA OFFICINALIS, HISTAMINUM HYDROCHLORICUM, KALI MURIATICUM, NATRUM MURIATICUM, SILICEASilver Star Brands9d36096b-022f-5cfa-e053-2995a90a381f2025-01-01WarningsExact identifier
unii: ETJ7Z6XBU4
FosrenolLANTHANUM CARBONATETakeda Pharmaceuticals America, Inc.f10776b2-2c25-4343-aabe-68f302e5cb542024-12-31Warnings, Adverse reactionsExact identifier
application number: NDA021468
application number: NDA204734
ndc (package): 54092-256-01
ndc (package): 54092-256-02
ndc (package): 54092-253-15
ndc (package): 54092-257-01
ndc (package): 54092-257-02
ndc (package): 54092-252-90
ndc (package): 54092-254-10
ndc (package): 54092-254-90
ndc (package): 54092-252-45
ndc (package): 54092-253-90
ndc (product): 54092-257
ndc (product): 54092-256
ndc (product): 54092-253
ndc (product): 54092-254
ndc (product): 54092-252
ndc11 (package): 54092025245
rxcui: 603112
rxcui: 542465
rxcui: 1551884
rxcui: 1551881
rxcui: 477347
rxcui: 603122
rxcui: 1551886
rxcui: 1551885
rxcui: 602635
rxcui: 642452
spl id: b29f2b53-6f45-447d-afb3-297ccc4ef8db
spl set id: f10776b2-2c25-4343-aabe-68f302e5cb54
unii: 490D9F069T
Trace Mineral CordARGENTUM METALLICUM, AURUM METALLICUM, BORON CITRATE, CALCAREA FLUORICA, CALCAREA PHOSPHORICA, CALCAREA SULPHURICA, CHROMIUM SULPHURICUM, COBALT GLUCONATE, CUPRUM SULPHURICUM, FERRUM PHOSPHORICUM, GERMANIUM SESQUIOXIDE, IODIUM, KALI BROMATUM, KALI MURIATICUM, KALI PHOSPHORICUM, KALI SULPHURICUM, LITHIUM CARBONICUM, MAGNESIA PHOSPHORICA, MANGANUM MURIATICUM, NATRUM MURIATICUM, NATRUM PHOSPHORICUM, NATRUM SULPHURICUM, SELENIUM METALLICUM, SILICEA, SODIUM MOLYBDATE, STRONTIUM CARBONICUM, VANADIUM METALLICUM,Energique, Inc.902dd68d-5ce1-481e-8938-6487dcc68dfc2024-12-19WarningsExact identifier
unii: ETJ7Z6XBU4
GeovitaCEREBRUM, CUPRUM MET, FERRUM MET, FORMICUM ACIDUM, SILICEARUBIMED AG0fcb5c06-d414-456c-a0ef-28e14018a7812024-11-29WarningsExact identifier
unii: ETJ7Z6XBU4
Para-SiJUGLANS REG, ABROTANUM, AESCULUS HIPP, ALLIUM SAT, ARSENICUM ALB, ARTEMISIA, BAPTISIA, CINA, CUPRUM MET, FILIX MAS, GRANATUM, IPECAC, LACHESIS, LYCOPODIUM, MERC VIV, NAPHTHALINUM, NAT MUR, NUX VOM, PULSATILLA, RATANHIA, RUTA, SABADILLA, SANTONINUM, SILICEA, SPIGELIA ANTH, TEREBINTHINA, TEUCRIUM MAR, THYMOLUM, ZINGIBERNewton Laboratories, Inc.27d41602-9dcb-eaa8-e063-6394a90a7cfa2024-11-26WarningsExact identifier
unii: ETJ7Z6XBU4
Para-SiJUGLANS REG, ABROTANUM, AESCULUS HIPP, ALLIUM SAT, ARSENICUM ALB, ARTEMISIA, BAPTISIA, CINA, CUPRUM MET, FILIX MAS, GRANATUM, IPECAC, LACHEIS, LYCOPODIUM, MERC VIV, NAPHTHALINUM, NAT MUR, NUX VOM, PULSATILLA, RATANHIA, RUTA, SABADILLA, SANTONINUM, SILICEA, SPIGELIA ANTH, TEREBINTHINA, TEUCRIUM MAR, THYMOLUM, ZINGIBERNewton Laboratories, Inc.27d4ddaf-9c07-a7fc-e063-6394a90adc0b2024-11-26WarningsExact identifier
unii: ETJ7Z6XBU4
Para-SiJUGLANS REG, ABROTANUM, AESCULUS HIPP, ALLIUM SAT, ARSENICUM ALB, ARTEMISIA, BAPTISIA, CINA, CUPRUM MET, FILIX MAS, GRANATUM, IPECAC, LACHESIS, LYCOPODIUM, MERC VIV, NAPHTHALINUM, NAT MUR NUX VOM, PULSATILLA, RATANHIA, RUTA, SABADILLA, SANTONINUM, SILICEA, SPIGELIA ANTH, TEREBINTHINA, TEUCRIUM MAR, THYMOLUM, ZINGIBERNewton Laboratories, Inc.27d5997b-1cae-41c2-e063-6394a90ac74a2024-11-26WarningsExact identifier
unii: ETJ7Z6XBU4
Hempvana Ultra Pain Relief Homeopathic Cream Platinum - Nerve ReliefARNICA MONTANA, ACONITUM NAPELLUS, HYPERICUM PERFORATUM, LEDUM PALUSTRE, MAGNESIA PHOSPHORICA, SECALE CORNUTUM, SILICEATELEBRANDS CORP2787f88c-752e-cbaa-e063-6394a90a732c2024-11-21WarningsExact identifier
unii: ETJ7Z6XBU4
Hempvana Ultra Pain Relief - Nerve ReliefARNICA MONTANA, ACONITUM NAPELLUS, HYPERICUM PERFORATUM, LEDUM PALUSTRE, MAGNESIA PHOSPHORICA, SECALE CORNUTUM, SILICEATELEBRANDS CORPf93a1ed0-5046-0355-e053-6294a90a6a902024-11-20WarningsExact identifier
unii: ETJ7Z6XBU4
ReHydrationADENOSINUM CYCLOPHOSPHORICUM, COFFEA CRUDA, GLANDULA SUPRARENALIS SUIS, HYPOTHALAMUS, KALI PHOS, NAT MUR, SARSAPARILLA, SILICEA, TARAXACUM, THYROIDINUMEnergetix Corporation37063a49-6b45-4167-875d-49c9dac3f79b2024-11-20WarningsExact identifier
unii: ETJ7Z6XBU4
MammaryplexECHINACEA (ANGUSTIFOLIA), MYRRHA, TRIGONELLA FOENUM-GRAECUM, PHYTOLACCA DECANDRA, HYDRASTIS CANADENSIS, LYMPH (SUIS), SPLEEN (SUIS), BRYONIA (ALBA), CONIUM MACULATUM, LAC CANINUM, LACHESIS MUTUS, SILICEA, BUFO RANA, MAMMARY GLAND (BOVINE)BioActive Nutritional, Inc.2be630bc-9fa6-42a6-b66d-99f91a58b1fa2024-11-15WarningsExact identifier
unii: ETJ7Z6XBU4

Reported adverse events (FAERS/openFDA)#

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