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 6 of 8 · 153 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TOBRAMYCIN AND DEXAMETHASONETOBRAMYCIN AND DEXAMETHASONEA-S Medication Solutions8d6a8a22-fd97-43e7-a89c-b1f32710a7732024-10-14Warnings, Adverse reactionsExact identifier
unii: 7S5I7G3JQL
DexamethasoneDEXAMETHASONEBryant Ranch Prepacke652b041-2a0b-4bcd-a420-5d026302edbb2024-09-23Warnings, Adverse reactionsExact identifier
rxcui: 197582
unii: 7S5I7G3JQL
Neomycin Polymyxin B Sulfates and DexamethasoneNEOMYCIN SULFATE, POLYMYXIN B SULFATE AND DEXAMETHASONEBausch & Lomb Incorporatedd6d78668-a978-4cd3-bbcd-1293b5044ec92024-09-15Warnings, Adverse reactionsExact identifier
unii: 7S5I7G3JQL
DexamethasoneDEXAMETHASONEDirect_rx214dea63-d77a-922a-e063-6294a90a967e2024-09-04Warnings, Adverse reactionsExact identifier
unii: 7S5I7G3JQL
Tobramycin and DexamethasoneTOBRAMYCIN AND DEXAMETHASONEA-S Medication Solutions11c2ba9a-7aa3-4f78-aa2f-2a35d26716812024-08-12Warnings, Adverse reactionsExact identifier
unii: 7S5I7G3JQL
Neomycin and Polymyxin B Sulfates and DexamethasoneNEOMYCIN SULFATE, POLYMYXIN B SULFATE AND DEXAMETHASONENuCare Pharmaceuticals,Inc.54da7bef-c3b0-4353-e054-00144ff8d46c2024-07-10Warnings, Adverse reactionsExact identifier
unii: 7S5I7G3JQL
DexamethasoneDEXAMETHASONEProficient Rx LP45fd8030-dbe3-4da4-9d0a-6549cf4f73592024-07-01Warnings, Adverse reactionsExact identifier
unii: 7S5I7G3JQL
DexamethasoneDEXAMETHASONEBryant Ranch Prepack710ce0fc-78b3-402d-a2ca-e5eda09f32112024-06-11Warnings, Adverse reactionsExact identifier
unii: 7S5I7G3JQL
Neomycin and Polymyxin B Sulfates and DexamethasoneNEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONEA-S Medication Solutions6791e6c3-514d-4b98-8887-ca2b894576b52024-06-10Warnings, Adverse reactionsExact identifier
unii: 7S5I7G3JQL
Neomycin Polymyxin B Sulfates and DexamethasoneNEOMYCIN SULFATE, POLYMYXIN B SULFATE AND DEXAMETHASONENuCare Pharmaceuticals,Inc.691bc5ca-5d61-60c2-e053-2991aa0abb932024-06-07Warnings, Adverse reactionsExact identifier
unii: 7S5I7G3JQL
Tobramycin and DexamethasoneTOBRAMYCIN AND DEXAMETHASONENuCare Pharmaceuticals,Inc.61693e79-81d1-3162-e053-2a91aa0ae9252024-06-06Warnings, Adverse reactionsExact identifier
unii: 7S5I7G3JQL
Ciprofloxacin and DexamethasoneCIPROFLOXACIN AND DEXAMETHASONEDr. Reddy's Laboratories, Inc.f07cf7d6-c233-884e-342d-c6c8cd2c84382024-05-30Warnings, Adverse reactionsExact identifier
unii: 7S5I7G3JQL
DexamethasoneDEXAMETHASONEBryant Ranch Prepackc75360d3-2e4f-4620-a8f0-db28b1aa704b2024-05-28Warnings, Adverse reactionsExact identifier
rxcui: 197582
unii: 7S5I7G3JQL
DexamethasoneDEXAMETHASONEZydus Lifesciences Limitede9012a11-6219-4272-aea2-b7328bbcf5232024-05-13Exact identifier
unii: 7S5I7G3JQL
DexamethasoneDEXAMETHASONEViona Pharmaceuticals Inc360d3af0-8f69-4e82-ab5f-1f70cc2025d42024-05-13Warnings, Adverse reactionsExact identifier
unii: 7S5I7G3JQL
DexamethasoneDEXAMETHASONENuCare Pharmaceuticals,Inc.17f56402-331e-2e3d-e063-6394a90acc0e2024-05-08Warnings, Adverse reactionsExact identifier
rxcui: 197582
unii: 7S5I7G3JQL
DexamethasoneDEXAMETHASONEBryant Ranch Prepack36f104ba-80b4-4713-aa74-f80483b7bded2024-04-03Warnings, Adverse reactionsExact identifier
application number: ANDA088481
rxcui: 197582
unii: 7S5I7G3JQL
DexamethasoneDEXAMETHASONEViona Pharmaceuticals Inc93bb34a7-c8ca-4dab-b2a0-cbe011e1090c2024-03-30Warnings, Adverse reactionsExact identifier
rxcui: 197582
rxcui: 197583
unii: 7S5I7G3JQL
DexamethasoneDEXAMETHASONEZydus Lifesciences Limited1e84a609-22a0-41b9-83a0-c45019c8cf9a2024-03-30Exact identifier
unii: 7S5I7G3JQL
DexamethasoneDEXAMETHASONEZydus Lifesciences Limited522a1a49-5540-4245-a15f-e3cdc0a97a5e2024-03-30Exact identifier
rxcui: 197582
rxcui: 197583
unii: 7S5I7G3JQL

Reported adverse events (FAERS/openFDA)#

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