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 1 of 8 · 160 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DexamethasoneDEXAMETHASONEREMEDYREPACK INC.8c5375a7-7a0d-4af0-8b86-bc87698ac3d12026-09-04Warnings, Adverse reactionsExact identifier
rxcui: 197582
unii: 7S5I7G3JQL
Dexamethasone IntensolDEXAMETHASONE INTENSOLSportpharm LLC77429dd3-e66d-4ab4-a3f3-5ae0b987ac172026-08-21Warnings, Adverse reactionsExact identifier
unii: 7S5I7G3JQL
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
application number: ANDA217001
rxcui: 197582
rxcui: 197583
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
rxcui: 197582
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
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
rxcui: 197582
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
rxcui: 197582
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
rxcui: 197582
unii: 7S5I7G3JQL
dexamethasoneDEXAMETHASONECardinal Health 107, LLC5622f8d2-1893-441b-8011-fa90c8a63b0b2026-05-05Warnings, Adverse reactionsExact identifier
rxcui: 197582
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

Reported adverse events (FAERS/openFDA)#

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