FDA.reportPublic FDA data

NDC 80425-0346-04 - 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
80425-0346-04
Package NDCs from labels
80425-0346-1, 80425-0346-2, 80425-0346-3, 80425-0346-4, 80425-0346-04
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 1 of 11 · 209 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DexamethasoneDEXAMETHASONEREMEDYREPACK INC.8c5375a7-7a0d-4af0-8b86-bc87698ac3d12026-09-04Warnings, Adverse reactionsExact identifier
unii: 7S5I7G3JQL
Dexamethasone IntensolDEXAMETHASONE INTENSOLSportpharm LLC77429dd3-e66d-4ab4-a3f3-5ae0b987ac172026-08-21Warnings, Adverse reactionsExact identifier
unii: 7S5I7G3JQL
Isopathic Phenolic RingsHOMEOPATHIC LIQUIDEnergetix Corporation98a7ca26-ccb7-43c7-bd65-892fcbacc8822026-08-11WarningsExact identifier
unii: C151H8M554
Lipo-ChordACETICUM AC, ACETYLSAL AC, ADRENOCORTICOTROPHIN, ALUMINA, ARSENICUM ALB, BORAGO, CEANOTHUS, CHELIDONIUM MAJ, CHIONANTHUS, CHLORAMPHENICOLUM, CHLORPROMAZINUM, CHOLESTERINUM, CORTISONE ACETICUM, DAMIANA, FOLLICULINUM, FUMARICUM AC, KALI IOD, LYCOPODIUM, NAT SULPHURICUM, NUX VOM, OLEUM MORRHUAE, PETROLEUM, PHENACETINUM, PHOSPHORICUM AC, PHOSPHORUS, PLUMB MET, SACCHARUM OFF, SILICEA, TARAXACUM, THYROIDINUM.Energetix Corporation5c83cbd5-46fb-48a0-a739-ff9c81e7129c2026-08-11WarningsExact identifier
unii: C151H8M554
TobraDexTOBRAMYCIN AND DEXAMETHASONENovartis Pharmaceuticals Corporation7f310e0e-0d3b-493d-b6c4-238493a2a9b92026-07-22Warnings, Adverse reactionsExact identifier
unii: 7S5I7G3JQL
DexamethasoneDEXAMETHASONESportpharm LLCa37486b9-4323-41fc-ac7e-869d95dc95682026-07-17Warnings, Adverse reactionsExact identifier
unii: 7S5I7G3JQL
Ciprofloxacin and DexamethasoneCIPROFLOXACIN AND DEXAMETHASONESportpharm LLC780a5554-54ef-4294-b681-8c5300b028b62026-07-13Warnings, Adverse reactionsExact identifier
unii: 7S5I7G3JQL
DexamethasoneDEXAMETHASONEREMEDYREPACK INC.f5c9b70b-b835-4f3b-9643-0aec50a0d3f22026-07-07Warnings, Adverse reactionsExact identifier
unii: 7S5I7G3JQL
Tobramycin and DexamethasoneTOBRAMYCIN AND DEXAMETHASONESportpharm LLCfa3d2fda-6857-4ef1-8dae-a2877f7569af2026-07-02Warnings, Adverse reactionsExact identifier
unii: 7S5I7G3JQL
DexamethasoneDEXAMETHASONEPangea Pharmaceuticals, LLCa41e6e26-9ebb-4b06-866e-a24af21c644c2026-06-29Warnings, Adverse reactionsExact identifier
unii: 7S5I7G3JQL
SET 4TE HOMOADEPS SUILLUS, BRYONIA (ALBA), CALCAREA PHOSPHORICA, CHOLINUM, DNA, DOPAMINE (HYDROCHLORIDE), FERRUM PHOSPHORICUM, FOLIC ACID, INSULINUM (HUMAN), LEPTIN, MAGNESIA MURIATICA, L-METHIONINE, METHYLCOBALAMIN, PROTEUS (VULGARIS), RHUS TOX, RIBOFLAVINUM, RUTA GRAVEOLENS, SACCHARUM OFFICINALE, THIOSINAMINUM, ZINCUM METALLICUMDeseret Biologicals, Inc.e7b8d75b-f2bc-4013-91e7-bf5bbec11a902026-06-25WarningsExact identifier
unii: C151H8M554
Ciprofloxacin and DexamethasoneCIPROFLOXACIN AND DEXAMETHASONERedpharm Drug546bf602-4b4c-cb08-e063-6394a90a2c552026-06-17Warnings, Adverse reactionsExact identifier
unii: 7S5I7G3JQL
DexamethasoneDEXAMETHASONEPD-Rx Pharmaceuticals, Inc.89e1d458-7caa-430f-9c54-360889899a732026-06-12Warnings, Adverse reactionsExact identifier
unii: 7S5I7G3JQL
DexamethasoneDEXAMETHASONEPD-Rx Pharmaceuticals, Inc.736861fa-1df8-4afd-ba4a-dd7d7bffd8652026-06-12Warnings, Adverse reactionsExact identifier
unii: 7S5I7G3JQL
Tobramycin and DexamethasoneTOBRAMYCIN AND DEXAMETHASONEREMEDYREPACK INC.c606945c-4ffc-4ee8-af04-a00de8ea92592026-06-11Warnings, Adverse reactionsExact identifier
unii: 7S5I7G3JQL
DexamethasoneDEXAMETHASONEPreferred Pharmaceuticals Inc79b65fd4-16a5-42e0-b041-61d7bda0a5ff2026-06-08Warnings, Adverse reactionsExact identifier
unii: 7S5I7G3JQL
TOBRAMYCIN AND DEXAMETHASONETOBRAMYCIN AND DEXAMETHASONEBryant Ranch Prepackdf4a7747-8dfa-4933-b4d2-a3d85c5f74f82026-06-08Warnings, Adverse reactionsExact identifier
unii: 7S5I7G3JQL
DexamethasoneDEXAMETHASONEREMEDYREPACK INC.8deaaaf7-3efd-4065-b29f-e5ef038030f82026-06-01Warnings, Adverse reactionsExact identifier
unii: 7S5I7G3JQL
TOBRAMYCIN AND DEXAMETHASONETOBRAMYCIN AND DEXAMETHASONEBryant Ranch Prepack1884ef6f-a60c-4a82-a7dc-fd48b7176db02026-05-28Warnings, Adverse reactionsExact identifier
unii: 7S5I7G3JQL
DexamethasoneDEXAMETHASONECardinal Health 107, LLCbf8acfdb-8dc8-4a69-90b0-33c680c421d62026-05-15Warnings, Adverse reactionsExact identifier
unii: 7S5I7G3JQL

Reported adverse events (FAERS/openFDA)#

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