FDA.reportPublic FDA data

NDC 80425-0328-01 - 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
80425-0328
Requested NDC
80425-0328-01
Package NDCs from labels
80425-0328-1, 80425-0328-01
Manufacturer
Advanced Rx Pharmacy of Tennessee, LLC
Effective date
2024-12-31
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, LLC2024-12-31HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80425-0328-1Dexamethasone12 in 1 BOTTLETABLET122

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0328DEXAMETHASONE TABLET [ADVANCED RX PHARMACY OF TENNESSEE, LLC]2Current NDC, 1 package rows20250102_fa16db27-3c8c-eb22-e053-6394a90add59.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0328-1EA - Each80425-03280ddf09bc-ab84-4379-be8c-e334212684bd12023-06-06

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 7 of 8 · 154 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DexamethasoneDEXAMETHASONEZydus Lifesciences Limited522a1a49-5540-4245-a15f-e3cdc0a97a5e2024-03-30Exact identifier
rxcui: 197582
rxcui: 197583
unii: 7S5I7G3JQL
DexamethasoneDEXAMETHASONEViona Pharmaceuticals Inc86afd383-7d6b-48f0-a803-9446fa1ded102024-03-29Warnings, Adverse reactionsExact identifier
unii: 7S5I7G3JQL
DexamethasoneDEXAMETHASONEChartwell RX, LLC3746066a-3c87-4238-945a-6dfb4d01a0722024-03-14Warnings, Adverse reactionsExact identifier
unii: 7S5I7G3JQL
DexamethasoneDEXAMETHASONENorthStar Rx LLC05c77a4c-c508-babd-e063-6294a90a450a2024-03-08Warnings, Adverse reactionsExact identifier
rxcui: 197582
rxcui: 197583
unii: 7S5I7G3JQL
DexamethasoneDEXAMETHASONEANI Pharmaceuticals, Inc.fe8cf911-84ef-47be-acb8-0501b546299b2024-03-04Warnings, Adverse reactionsExact identifier
rxcui: 197582
rxcui: 197583
unii: 7S5I7G3JQL
dexamethasoneDEXAMETHASONEAmneal Pharmaceuticals NY LLCac71f888-c83a-46a5-921c-1ebdf6cfadc12024-02-21Warnings, Adverse reactionsExact identifier
rxcui: 197582
rxcui: 197583
unii: 7S5I7G3JQL
dexamethasoneDEXAMETHASONEAmneal Pharmaceuticals NY LLCb9eb9a30-c1da-4d38-8ea8-616a254e2afc2024-02-21Warnings, Adverse reactionsExact identifier
unii: 7S5I7G3JQL
DexamethasoneDEXAMETHASONEAlvogen Inc.9ab26af9-8196-e3d3-76a3-75227fd4e1c32024-02-21Warnings, Adverse reactionsExact identifier
application number: ANDA088481
ndc (product): 47781-914
rxcui: 197582
rxcui: 197583
spl id: f5d1d20f-dcb0-9ddf-b436-165cf014f5fa
spl set id: 9ab26af9-8196-e3d3-76a3-75227fd4e1c3
unii: 7S5I7G3JQL
Neo/Poly-B/Dex Ophth OintNEO/POLY-B/DEX OPHTH OINTDirect_Rx0ec1dfdf-b63f-fb0c-e063-6294a90a843d2024-01-12Warnings, Adverse reactionsExact identifier
unii: 7S5I7G3JQL
TOBRAMYCIN AND DEXAMETHASONETOBRAMYCIN AND DEXAMETHASONEBryant Ranch Prepacka5f0b05b-3dec-4fe8-8106-e41e668a512d2024-01-12Warnings, Adverse reactionsExact identifier
unii: 7S5I7G3JQL
TOBRAMYCIN AND DEXAMETHASONETOBRAMYCIN AND DEXAMETHASONEBryant Ranch Prepack3c63c481-ce57-41ca-993f-5a5b665fa1e42024-01-12Warnings, Adverse reactionsExact identifier
unii: 7S5I7G3JQL
DEXAMETHASONEDEXAMETHASONEDirect Rx3ff06262-4c6f-4423-99fa-b4d8191ea1332024-01-09Warnings, Adverse reactionsExact identifier
unii: 7S5I7G3JQL
Dexamethasone 1.5 mgDEXAMETHASONE 1.5 MGProficient Rx LP42db0356-3948-444c-bda3-1226b4ca89852024-01-01Warnings, Adverse reactionsExact identifier
unii: 7S5I7G3JQL
MAXITROLNEOMYCIN SULFATE, POLYMYXIN B SULFATE AND DEXAMETHASONESandoz Inc5776c435-ac60-49b6-8db1-23a3012b91552023-12-29Warnings, Adverse reactionsExact identifier
unii: 7S5I7G3JQL
Ciprofloxacin and dexamethasoneCIPROFLOXACIN AND DEXAMETHASONEARMAS PHARMACEUTICALS INC.eed6b293-6bbe-4bd3-ad9d-3849e0eb6c052023-11-17Warnings, Adverse reactionsExact identifier
unii: 7S5I7G3JQL
Neomycin and Polymyxin B Sulfates and DexamethasoneNEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND DEXAMETHASONEA-S Medication Solutions0d273133-0ce9-4fe6-b873-7f85aac254862023-11-01Warnings, Adverse reactionsExact identifier
unii: 7S5I7G3JQL
Tobramycin and DexamethasoneTOBRAMYCIN AND DEXAMETHASONEBausch & Lomb Incorporated33de419e-a89b-47e5-952b-87e837f5d5312023-08-31Warnings, Adverse reactionsExact identifier
unii: 7S5I7G3JQL
Tobramycin and DexamethasoneTOBRAMYCIN AND DEXAMETHASONEA-S Medication Solutionse4ddce2f-1b91-46e1-a8f0-a38394d4e6722023-07-11Warnings, Adverse reactionsExact identifier
unii: 7S5I7G3JQL
MAXITROLNEOMYCIN SULFATE, POLYMYXIN B SULFATE AND DEXAMETHASONENovartis Pharmaceuticals Corporation22c6d2db-85af-4a3b-a014-80d901a867172023-06-27Warnings, Adverse reactionsExact identifier
unii: 7S5I7G3JQL
Neomycin and Polymyxin B Sulfates and DexamethasoneNEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND DEXAMETHASONEBausch & Lomb Incorporated4456d10b-9995-4430-b692-a8859ea36deb2023-06-01Warnings, Adverse reactionsExact identifier
unii: 7S5I7G3JQL

Reported adverse events (FAERS/openFDA)#

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