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 4 of 8 · 159 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TOBRAMYCIN AND DEXAMETHASONETOBRAMYCIN AND DEXAMETHASONEBryant Ranch Prepack15280680-edc0-4e5d-99ee-117a6f5893072025-10-21Warnings, Adverse reactionsExact identifier
unii: 7S5I7G3JQL
Seacall Dexamethasone Ointment.DEXAMETHASONE OINTMENTGuangdong Quadrant Ecological Technology Co., Ltd.201adf67-773c-34a2-e063-6394a90ac5252025-10-15WarningsExact identifier
unii: 7S5I7G3JQL
Dexamethasone 1.5 mgDEXAMETHASONE 1.5 MGLarken Laboratories, Inc.7b997c26-e6a3-403c-93fb-b1290cf5dbad2025-10-15Warnings, Adverse reactionsExact identifier
unii: 7S5I7G3JQL
DexamethasoneDEXAMETHASONEPD-Rx Pharmaceuticals, Inc.2ceb3a01-f5bb-4538-b5c1-cea400901d022025-10-15Warnings, Adverse reactionsExact identifier
unii: 7S5I7G3JQL
Dexamethasone 1.5 mgDEXAMETHASONE 1.5 MGLarken Laboratories, Inc.fcc75691-974e-4a67-b9d7-64dde72b55952025-10-15Warnings, Adverse reactionsExact identifier
unii: 7S5I7G3JQL
DexamethasoneDEXAMETHASONEApotex Corp.bfaa71cb-e517-8d94-f64b-8cdbf7b8fbf22025-09-17Warnings, Adverse reactionsExact identifier
rxcui: 197582
rxcui: 197583
unii: 7S5I7G3JQL
dexamethasoneDEXAMETHASONEMajor Pharmaceuticals5ec5b0e6-7fa8-4afc-97a4-d185484ada8b2025-09-08Warnings, Adverse reactionsExact identifier
unii: 7S5I7G3JQL
DexamethasoneDEXAMETHASONERising Pharma Holdings, Inc.7cf5c17c-a80b-4547-83b2-0d53e2b933f72025-09-05Warnings, Adverse reactionsExact identifier
unii: 7S5I7G3JQL
Neomycin Polymyxin B Sulfates and DexamethasoneNEOMYCIN SULFATE, POLYMYXIN B SULFATE AND DEXAMETHASONEPreferred Pharmaceuticals, Inc.449a6fd8-c2ac-40d0-b74a-e5c7fc6670f32025-08-18Warnings, Adverse reactionsExact identifier
unii: 7S5I7G3JQL
DexamethasoneDEXAMETHASONEA-S Medication Solutions16c59e9a-8e4f-4300-bbbb-bcc982c18fc82025-08-15Warnings, Adverse reactionsExact identifier
rxcui: 197582
unii: 7S5I7G3JQL
DexamethasoneDEXAMETHASONEA-S Medication Solutions89af5591-eebf-44e7-827f-ce3b123123e42025-08-15Warnings, Adverse reactionsExact identifier
rxcui: 197582
unii: 7S5I7G3JQL
DexamethasoneDEXAMETHASONENuCare Pharmaceuticals,Inc.141e16a7-1f3d-3943-e063-6294a90ac5a92025-07-30Warnings, Adverse reactionsExact identifier
rxcui: 197582
unii: 7S5I7G3JQL
Dexamethasone IntensolDEXAMETHASONE INTENSOLHikma Pharmaceuticals USA, Inc.b15200fb-1826-472b-a907-e677a272513b2025-06-06Warnings, Adverse reactionsExact identifier
rxcui: 197582
rxcui: 197583
unii: 7S5I7G3JQL
DexamethasoneDEXAMETHASONEAdvanced Rx of Tennessee, LLC348f5a56-978d-4272-e063-6294a90afdb62025-05-07Warnings, Adverse reactionsExact identifier
application number: ANDA217001
ndc (package): 80425-0515-1
ndc (product): 80425-0515
ndc11 (package): 80425051501
rxcui: 197582
spl id: 348f5a61-1623-3f2f-e063-6394a90addbe
spl set id: 348f5a56-978d-4272-e063-6294a90afdb6
unii: 7S5I7G3JQL
MAXIDEXDEXAMETHASONEHarrow Eye, LLC35e47fcd-e020-43e5-8322-41f8060d220d2025-05-05Warnings, Adverse reactionsExact identifier
unii: 7S5I7G3JQL
DexamethasoneDEXAMETHASONEPD-Rx Pharmaceuticals, Inc.a5609df4-4933-4f85-a7b8-bc54a70a2bac2025-04-30Warnings, Adverse reactionsExact identifier
unii: 7S5I7G3JQL
DexamethasoneDEXAMETHASONEMarlex Pharmaceuticals, Inc7b51ffce-ec64-4b49-8870-b9666537c5412025-04-22Warnings, Adverse reactionsExact identifier
unii: 7S5I7G3JQL
DEXTENZADEXAMETHASONEOcular Therapeutix, Inc.7514e6b8-c33f-4fbf-8810-ef520e1eb4bd2025-04-18Warnings, Adverse reactionsExact identifier
unii: 7S5I7G3JQL
NEOMYCIN POLYMYXIN B SULFATES AND DEXAMETHASONENEOMYCIN SULFATE, POLYMYXIN B SULFATE AND DEXAMETHASONE SUSPENSION/ DROPSDirectRxd5e00bad-abb4-63ad-e053-2a95a90a5abb2025-04-15Warnings, Adverse reactionsExact identifier
unii: 7S5I7G3JQL
Tobramycin and DexamethasoneTOBRAMYCIN AND DEXAMETHASONESandoz Inc05fd0c36-39b4-4a43-8490-eb8dfc0920ae2025-04-07Warnings, Adverse reactionsExact identifier
unii: 7S5I7G3JQL

Reported adverse events (FAERS/openFDA)#

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