FDA.reportPublic FDA data

NDC 80425-0515-01 - 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
80425-0515
Requested NDC
80425-0515-01
Package NDCs from labels
80425-0515-1, 80425-0515-01
Manufacturer
Advanced Rx of Tennessee, LLC
Effective date
2025-05-07
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Dexamethasone - Advanced Rx of Tennessee, LLCAdvanced Rx of Tennessee, LLC2025-05-07HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80425-0515-1Dexamethasone12 in 1 BOTTLETABLET121

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0515DEXAMETHASONE TABLET [ADVANCED RX OF TENNESSEE, LLC]1Current NDC, 1 package rows20250508_348f5a56-978d-4272-e063-6294a90afdb6.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0515-1EA - Each80425-05157f8eb581-7677-4241-908f-fab0b2f1577012025-06-13

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 3 of 8 · 159 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Neomycin and Polymyxin B Sulfates and DexamethasoneNEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND DEXAMETHASONEPreferred Pharmaceuticals Inc.e42d4837-77c2-40c3-8705-20966a51a8222026-01-19Warnings, Adverse reactionsExact identifier
unii: 7S5I7G3JQL
Lotrimin Daily Sweat and Odor ControlTOPICAL STARCHBayer HealthCare LLC.9ec5c80d-b550-496f-e053-2a95a90a54892026-01-16WarningsExact identifier
unii: O8232NY3SJ
DEXAMETHASONEDEXAMETHASONEBryant Ranch Prepack075717e3-be2a-4bb3-bead-492761bfb2872026-01-09Warnings, Adverse reactionsExact identifier
unii: 7S5I7G3JQL
HemadyDEXAMETHASONEEdenbridge Pharmaceuticals LLC.6b9cf32c-6d60-4853-bbfd-2304ffc2c1292026-01-09Warnings, Adverse reactionsExact identifier
unii: 7S5I7G3JQL
Neomycin Polymyxin B Sulfates and DexamethasoneNEOMYCIN SULFATE, POLYMYXIN B SULFATE AND DEXAMETHASONEA-S Medication Solutionsadcc540e-9275-4a7c-918a-36fa2314acd22026-01-05Warnings, Adverse reactionsExact identifier
unii: 7S5I7G3JQL
Medicated Cornstarch Baby PowderACTIVE CORN STARCHDavion, Inc.e39032d1-c8cd-4a41-af10-126970b8ad382025-12-29WarningsExact identifier
unii: O8232NY3SJ
Ciprofloxacin and dexamethasoneCIPROFLOXACIN AND DEXAMETHASONERedpharm Drug2fd20fcb-222c-bd38-e063-6294a90ac9cd2025-12-27Warnings, Adverse reactionsExact identifier
unii: 7S5I7G3JQL
DexamethasoneDEXAMETHASONENorthwind Health Company, LLCaa30086a-8551-413e-9cf2-6393093cfcfd2025-12-26Warnings, Adverse reactionsExact identifier
rxcui: 197582
unii: 7S5I7G3JQL
DexamethasoneDEXAMETHASONEGolden State Medical Supply, Inc.a7455c92-41ce-4e87-e053-2995a90a610f2025-12-11Warnings, Adverse reactionsExact identifier
rxcui: 197582
unii: 7S5I7G3JQL
DEXAMETHASONEDEXAMETHASONEPD-Rx Pharmaceuticals, Inc.a8d6792e-757e-4dc6-adf5-0d92110754282025-12-09Warnings, Adverse reactionsExact identifier
rxcui: 197582
unii: 7S5I7G3JQL
DexamethasoneDEXAMETHASONEANI Pharmaceuticals, Inc.5d9b22ca-c619-4ee3-98eb-74544d0d5cb32025-12-04Warnings, Adverse reactionsExact identifier
unii: 7S5I7G3JQL
TOBRAMYCIN AND DEXAMETHASONETOBRAMYCIN AND DEXAMETHASONERedpharm Drug3dd00c21-ae42-0613-e063-6394a90a80122025-12-02Warnings, Adverse reactionsExact identifier
unii: 7S5I7G3JQL
DexamethasoneDEXAMETHASONEKesin Pharma Corporation43e2a24a-4465-5787-e063-6394a90a0b812025-11-18Warnings, Adverse reactionsExact identifier
unii: 7S5I7G3JQL
DEXAMETHASONEDEXAMETHASONEKanchan Healthcare Inc02f7bf9c-1aa3-4734-8a3e-1f49498055d72025-11-12Warnings, Adverse reactionsExact identifier
unii: 7S5I7G3JQL
DexamethasoneDEXAMETHASONEProficient Rx LP429d0d32-a1ff-481b-b4e9-c0b17b3610a12025-11-01Warnings, Adverse reactionsExact identifier
application number: ANDA217001
rxcui: 197582
unii: 7S5I7G3JQL
DexamethasoneDEXAMETHASONEAdvanced Rx Pharmacy of Tennessee, LLC01cfaa3e-5e30-18fa-e063-6394a90a084e2025-10-29Warnings, Adverse reactionsExact identifier
unii: 7S5I7G3JQL
MaxitrolNEOMYCIN SULFATE, POLYMYXIN B SULFATE AND DEXAMETHASONEHarrow Eye, LLCecfb954f-5554-0ad2-e053-2995a90a75162025-10-24Warnings, Adverse reactionsExact identifier
unii: 7S5I7G3JQL
DEXAMETHASONEDEXAMETHASONEAdvagen Pharma Ltd.3c1729db-8ba3-4cba-9eff-ab4ae2c061c22025-10-22Warnings, Adverse reactionsExact identifier
rxcui: 197582
rxcui: 197583
unii: 7S5I7G3JQL
TOBRAMYCIN AND DEXAMETHASONETOBRAMYCIN AND DEXAMETHASONEBryant Ranch Prepack3e541ebf-2f7e-4cc0-9928-780353aa76572025-10-21Warnings, Adverse reactionsExact identifier
unii: 7S5I7G3JQL
TOBRAMYCIN AND DEXAMETHASONETOBRAMYCIN AND DEXAMETHASONEBryant Ranch Prepack3e5cd7f9-1f88-4d33-be25-c362de4dc87b2025-10-21Warnings, Adverse reactionsExact identifier
unii: 7S5I7G3JQL

Reported adverse events (FAERS/openFDA)#

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