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 5 of 8 · 158 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DexamethasoneDEXAMETHASONEProficient Rx LP3f2fe98a-ab42-4bec-bf97-c090567f9ad62025-04-01Warnings, Adverse reactionsExact identifier
rxcui: 197582
unii: 7S5I7G3JQL
DexamethasoneDEXAMETHASONEBionpharma Inc.,401ec088-984a-49ab-b317-747c2b9b9e222025-03-05Warnings, Adverse reactionsExact identifier
unii: 7S5I7G3JQL
DexamethasoneDEXAMETHASONEBionpharma Inc.,3166db4f-66a5-496a-a194-3cc01b7347d32025-03-05Warnings, Adverse reactionsExact identifier
application number: ANDA217001
ndc (product): 69452-277
rxcui: 197582
rxcui: 197583
spl id: 2f9dcbaf-165e-5594-e063-6394a90a9dc5
spl set id: 3166db4f-66a5-496a-a194-3cc01b7347d3
unii: 7S5I7G3JQL
Ciprofloxacin and DexamethasoneCIPROFLOXACIN AND DEXAMETHASONENuCare Pharmaceuticals, Inc.2f780550-ecbf-98fc-e063-6294a90a11c02025-03-03Warnings, Adverse reactionsExact identifier
unii: 7S5I7G3JQL
Neomycin and Polymyxin B Sulfates and DexamethasoneNEOMYCIN SULFATE, POLYMYXIN B SULFATE AND DEXAMETHASONESandoz Inc.cf1a6da8-ba79-4bff-a13b-6effb67f6c1c2025-02-20Warnings, Adverse reactionsExact identifier
unii: 7S5I7G3JQL
DexamethasoneDEXAMETHASONEPreferred Pharmaceuticals Inc.b883860c-27ba-4bac-8ae3-4cf4d82d50712025-02-10Warnings, Adverse reactionsExact identifier
application number: ANDA217001
rxcui: 197582
unii: 7S5I7G3JQL
Tobramycin and DexamethasoneTOBRAMYCIN AND DEXAMETHASONENuCare Pharmaceuticals,Inc.b7b39ad5-e158-b8fe-e053-2995a90a52792025-02-07Warnings, Adverse reactionsExact identifier
unii: 7S5I7G3JQL
DexamethasoneDEXAMETHASONEPrasco Laboratoriesbfce6b49-f7ff-4ec7-9580-b730f0a207d72025-02-01Warnings, Adverse reactionsExact identifier
rxcui: 197582
unii: 7S5I7G3JQL
Ciprofloxacin and DexamethasoneCIPROFLOXACIN AND DEXAMETHASONESandoz Inc89fef4d2-7078-47f1-96bf-aca50b135a972025-01-31Warnings, Adverse reactionsExact identifier
unii: 7S5I7G3JQL
DexamethasoneDEXAMETHASONERedpharm Drug, Inc.115e1bfb-1697-d567-e063-6394a90a78e52025-01-23Warnings, Adverse reactionsExact identifier
rxcui: 197582
unii: 7S5I7G3JQL
DexamethasoneDEXAMETHASONEDirect_Rxe90cb7f5-5e99-fbf3-e053-2995a90a70aa2025-01-22Warnings, Adverse reactionsExact identifier
unii: 7S5I7G3JQL
DexamethasoneDEXAMETHASONEDirect_Rxfade983c-81fb-df94-e053-6394a90a75602025-01-22Warnings, Adverse reactionsExact identifier
unii: 7S5I7G3JQL
DexamethasoneDEXAMETHASONEDirect_Rx044d7898-4ab6-a0b3-e063-6294a90acdba2025-01-22Warnings, Adverse reactionsExact identifier
rxcui: 197582
unii: 7S5I7G3JQL
DEXAMETHASONEDEXAMETHASONEDirect Rxcc7140de-a205-f675-e053-2995a90ac22b2025-01-20Warnings, Adverse reactionsExact identifier
rxcui: 197582
unii: 7S5I7G3JQL
Tobradex STTOBRAMYCIN / DEXAMETHASONEEyevance Pharmaceuticals, LLCc2d7325e-4f58-5590-e053-2a95a90ace1b2025-01-16Warnings, Adverse reactionsExact identifier
unii: 7S5I7G3JQL
DexamethasoneDEXAMETHASONEPreferred Pharmaceuticals Inc.955db121-79f4-47eb-8c10-01b2d8b411e42025-01-13Warnings, Adverse reactionsExact identifier
unii: 7S5I7G3JQL
Tobramycin and DexamethasoneTOBRAMYCIN AND DEXAMETHASONEAdvanced Rx of Tennessee, LLC09315f0b-f15a-30d5-e063-6394a90ac8dd2024-12-31Warnings, Adverse reactionsExact identifier
unii: 7S5I7G3JQL
NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONENEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONEAdvanced Rx Pharmacy of Tennessee, LLCf1a05d5f-74f2-17a1-e053-2995a90ab0e72024-12-31Warnings, Adverse reactionsExact identifier
unii: 7S5I7G3JQL
Tobramycin and dexamethasoneTOBRAMYCIN AND DEXAMETHASONEAdvanced Rx Pharmacy of Tennessee, LLCf4c00d9c-3a17-06a0-e053-2a95a90a84132024-12-31Warnings, Adverse reactionsExact identifier
unii: 7S5I7G3JQL
DexamethasoneDEXAMETHASONEAdvanced Rx Pharmacy of Tennessee, LLCfa16db27-3c8c-eb22-e053-6394a90add592024-12-31Warnings, Adverse reactionsExact identifier
rxcui: 197582
unii: 7S5I7G3JQL

Reported adverse events (FAERS/openFDA)#

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