FDA.reportPublic FDA data

NDC 80425-0346-01 - Dexamethasone

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
80425-0346
Requested NDC
80425-0346-01
Package NDCs from labels
80425-0346-1, 80425-0346-2, 80425-0346-3, 80425-0346-4, 80425-0346-01
Manufacturer
Advanced Rx Pharmacy of Tennessee, LLC
Effective date
2025-10-29
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Dexamethasone - Advanced Rx Pharmacy of Tennessee, LLCAdvanced Rx Pharmacy of Tennessee, LLC2025-10-29HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80425-0346-1Dexamethasone21 in 1 BOTTLETABLET213
80425-0346-2Dexamethasone27 in 1 BOTTLETABLET273
80425-0346-3Dexamethasone49 in 1 BOTTLETABLET493
80425-0346-4Dexamethasone60 in 1 BOTTLETABLET603

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0346DEXAMETHASONE TABLET [ADVANCED RX PHARMACY OF TENNESSEE, LLC]2Current NDC, 4 package rows20250102_01cfaa3e-5e30-18fa-e063-6394a90a084e.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0346-1EA - Each80425-0346cc30e2dc-1d7e-4d05-9c79-650d6a01ee1912023-09-05
80425-0346-2EA - Each80425-0346f4c3be7a-7231-40e4-8035-445481a639a312023-09-05
80425-0346-3EA - Each80425-0346a2a91936-6977-48be-9b70-53832fb4db6c12023-09-05
80425-0346-4EA - Each80425-0346f76dfd8e-4c38-42e6-91ce-374d4f4a733b12025-12-16

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 2 of 11 · 208 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
dexamethasoneDEXAMETHASONECardinal Health 107, LLC5622f8d2-1893-441b-8011-fa90c8a63b0b2026-05-05Warnings, Adverse reactionsExact identifier
unii: 7S5I7G3JQL
DexamethasoneDEXAMETHASONESportpharm LLC12d19271-867b-41ae-a6d2-7e8de36370112026-04-24Warnings, Adverse reactionsExact identifier
unii: 7S5I7G3JQL
Caldesene BabySTARCH, CORN AND ZINC OXIDEInsight Pharmaceuticals LLC9f12dee2-7afa-45e9-a729-0fd42bb777152026-04-22WarningsExact identifier
unii: O8232NY3SJ
Caldesene Medicated ProtectingCORNSTARCH AND ZINC OXIDEInsight Pharmaceuticals LLCffc92a0f-a7cf-4a46-b2f1-089df2bbb96b2026-04-22WarningsExact identifier
unii: O8232NY3SJ
DexamethasoneDEXAMETHASONEPangea Pharmaceuticals, LLC37607468-0331-44c0-9bb4-5c614c7b69d42026-04-19Warnings, Adverse reactionsExact identifier
unii: 7S5I7G3JQL
Ciprofloxacin and dexamethasoneCIPROFLOXACIN AND DEXAMETHASONESentiss Pharmaceuticals LLC355fa56f-d7a8-444e-9dec-8ba1fa4ab0d82026-04-16Warnings, Adverse reactionsExact identifier
unii: 7S5I7G3JQL
ConnectionANACARDIUM ORIENTALE, AURUM MURIATICUM NATRONATUM, CAMPHORA, DNA, GERMANIUM METALLICUM, HELLEBORUS NIGER, HYDROGEN, LAC CANINUM, LAC MATERNA HUMANUM, LITHIUM CARBONICUM, LITHIUM CARBONICUM, MAGNESIA OXYDATA, NATRUM CARBONICUM, NEON, OXYTOCIN, PLACENTA TOTALIS SUIS, RHUS GLABRA, SACCHARUM OFFICINALE, STRAMONIUM, THUJA OCCIDENTALISDeseret Biologicals, Inc.4a8be3aa-9bd9-4bb1-af98-a940c13b2bd02026-04-10WarningsExact identifier
unii: C151H8M554
ConnectionANACARDIUM ORIENTALE, AURUM MURIATICUM NATRONATUM, CAMPHORA, DNA, GERMANIUM METALLICUM, HELLEBORUS NIGER, HYDROGEN, LAC CANINUM, LAC MATERNA HUMANUM, LITHIUM CARBONICUM, LITHIUM CARBONICUM, MAGNESIA OXYDATA, NATRUM CARBONICUM, NEON, OXYTOCIN, PLACENTA TOTALIS SUIS, RHUS GLABRA, SACCHARUM OFFICINALE, STRAMONIUM, THUJA OCCIDENTALISDeseret Biologicals, Inc.214eb19a-e7a2-421c-9f34-724ce430185c2026-04-10WarningsExact identifier
unii: C151H8M554
Ciprofloxacin and dexamethasoneCIPROFLOXACIN AND DEXAMETHASONESun Pharmaceutical Industries, Inc.641bad60-9b9e-43ea-936e-5c38f27835b22026-04-02Warnings, Adverse reactionsExact identifier
unii: 7S5I7G3JQL
dexamethasoneDEXAMETHASONEPreferred Pharmaceuticals Inc.4c619d48-8cf9-4085-8405-c8f066bce19c2026-04-01Warnings, Adverse reactionsExact identifier
unii: 7S5I7G3JQL
DexamethasoneDEXAMETHASONEPreferred Pharmaceuticals, Inc.c4d1e578-a1d2-4d5e-8426-6b2c39f0d9bd2026-04-01Warnings, Adverse reactionsExact identifier
unii: 7S5I7G3JQL
Tobramycin and DexamethasoneTOBRAMYCIN AND DEXAMETHASONENuCare Pharmaceuticals,Inc.c33e84ba-4c0c-f738-e053-2995a90aa20a2026-03-27Warnings, Adverse reactionsExact identifier
unii: 7S5I7G3JQL
dexamethasoneDEXAMETHASONEMajor Pharmaceuticals64b46398-9b97-45e8-b1ba-1a202d5744482026-03-26Warnings, Adverse reactionsExact identifier
unii: 7S5I7G3JQL
Tobramycin and DexamethasoneTOBRAMYCIN AND DEXAMETHASONESportpharm LLC7ed85675-bc46-4dd6-bb8f-7e98c3eb84e22026-03-20Warnings, Adverse reactionsExact identifier
unii: 7S5I7G3JQL
Ciprofloxacin and dexamethasoneCIPROFLOXACIN AND DEXAMETHASONENuCare Pharmaceutical, Inc.4d650d9d-a98a-2dbe-e063-6294a90a00772026-03-19Warnings, Adverse reactionsExact identifier
unii: 7S5I7G3JQL
Drop20FUCUS VESICULOSUS, CHELIDONIUM MAJUS, KALI PHOSPHORICUM, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, QUERCUS GLANDIUM SPIRITUS, QUERCUS ROBUR, NUX VOMICA, PHYTOLACCA DECANDRA, ORNITHOGALUM UMBELLATUM, AGNUS CASTUS, BERBERIS AQUIFOLIUM, BERBERIS VULGARIS, SACCHARUM OFFICINALE, SOLIDAGO VIRGAUREA, CALCAREA CARBONICA, CARBO VEGETABILIS, MAGNESIA PHOSPHORICA, NATRUM PHOSPHORICUM, SINAPIS ARVENSIS, FLOS, UBIDECARENONUM, GRAPHITES, HYPOPHYSIS SUIS, PLACENTA TOTALIS SUIS, HYPOTHALAMUS (BOVINE)Pick Enterprises Corpbaa96813-dc95-472e-a834-880a0cd484a72026-03-13WarningsExact identifier
unii: C151H8M554
Appetrol 20FUCUS VESICULOSUS, CHELIDONIUM MAJUS, KALI PHOSPHORICUM, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, QUERCUS GLANDIUM SPIRITUS, QUERCUS ROBUR, NUX VOMICA, PHYTOLACCA DECANDRA, ORNITHOGALUM UMBELLATUM, AGNUS CASTUS, BERBERIS AQUIFOLIUM, BERBERIS VULGARIS, SACCHARUM OFFICINALE, SOLIDAGO VIRGAUREA, CALCAREA CARBONICA, CARBO VEGETABILIS, MAGNESIA PHOSPHORICA, NATRUM PHOSPHORICUM, SINAPIS ARVENSIS, FLOS, UBIDECARENONUM, GRAPHITES, HYPOPHYSIS SUIS, PLACENTA TOTALIS SUIS, HYPOTHALAMUS (BOVINE)Carbalor LLCd66234a3-2477-42be-8f7b-283e3a5f87ed2026-03-12WarningsExact identifier
unii: C151H8M554
OZURDEXDEXAMETHASONEAllergan, Inc.4b204f44-6e8a-4d17-803c-268f0b04679f2026-03-11Warnings, Adverse reactionsExact identifier
unii: 7S5I7G3JQL
Tobramycin and DexamethasoneTOBRAMYCIN AND DEXAMETHASONEPreferred Pharmaceuticals Inc.8a143864-e36b-49bf-91b4-c6cc1a9280312026-02-26Warnings, Adverse reactionsExact identifier
unii: 7S5I7G3JQL
Ciprofloxacin and DexamethasoneCIPROFLOXACIN HYDROCHLORIDE AND DEXAMETHASONEUpsher-Smith Laboratories, LLC9c5994d1-01d1-493c-a6ae-94754cd593892026-02-13Warnings, Adverse reactionsExact identifier
unii: 7S5I7G3JQL

Reported adverse events (FAERS/openFDA)#

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