FDA.reportPublic FDA data

NDC 80425-0346-01 - 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
80425-0346
Requested NDC
80425-0346-01
Package NDCs from labels
80425-0346-1, 80425-0346-2, 80425-0346-3, 80425-0346-4, 80425-0346-01
Manufacturer
Advanced Rx Pharmacy of Tennessee, LLC
Effective date
2025-10-29
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, LLC2025-10-29HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80425-0346-1Dexamethasone21 in 1 BOTTLETABLET213
80425-0346-2Dexamethasone27 in 1 BOTTLETABLET273
80425-0346-3Dexamethasone49 in 1 BOTTLETABLET493
80425-0346-4Dexamethasone60 in 1 BOTTLETABLET603

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0346DEXAMETHASONE TABLET [ADVANCED RX PHARMACY OF TENNESSEE, LLC]2Current NDC, 4 package rows20250102_01cfaa3e-5e30-18fa-e063-6394a90a084e.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0346-1EA - Each80425-0346cc30e2dc-1d7e-4d05-9c79-650d6a01ee1912023-09-05
80425-0346-2EA - Each80425-0346f4c3be7a-7231-40e4-8035-445481a639a312023-09-05
80425-0346-3EA - Each80425-0346a2a91936-6977-48be-9b70-53832fb4db6c12023-09-05
80425-0346-4EA - Each80425-0346f76dfd8e-4c38-42e6-91ce-374d4f4a733b12025-12-16

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 11 · 208 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DEXAMETHASONEDEXAMETHASONEPD-Rx Pharmaceuticals, Inc.a8d6792e-757e-4dc6-adf5-0d92110754282025-12-09Warnings, Adverse reactionsExact identifier
unii: 7S5I7G3JQL
DexamethasoneDEXAMETHASONEANI Pharmaceuticals, Inc.5d9b22ca-c619-4ee3-98eb-74544d0d5cb32025-12-04Warnings, Adverse reactionsExact identifier
unii: 7S5I7G3JQL
TOBRAMYCIN AND DEXAMETHASONETOBRAMYCIN AND DEXAMETHASONERedpharm Drug3dd00c21-ae42-0613-e063-6394a90a80122025-12-02Warnings, Adverse reactionsExact identifier
unii: 7S5I7G3JQL
DexamethasoneDEXAMETHASONEKesin Pharma Corporation43e2a24a-4465-5787-e063-6394a90a0b812025-11-18Warnings, Adverse reactionsExact identifier
unii: 7S5I7G3JQL
DEXAMETHASONEDEXAMETHASONEKanchan Healthcare Inc02f7bf9c-1aa3-4734-8a3e-1f49498055d72025-11-12Warnings, Adverse reactionsExact identifier
unii: 7S5I7G3JQL
DexamethasoneDEXAMETHASONEProficient Rx LP429d0d32-a1ff-481b-b4e9-c0b17b3610a12025-11-01Warnings, Adverse reactionsExact identifier
unii: 7S5I7G3JQL
DexamethasoneDEXAMETHASONEAdvanced Rx Pharmacy of Tennessee, LLC01cfaa3e-5e30-18fa-e063-6394a90a084e2025-10-29Warnings, Adverse reactionsExact identifier
application number: ANDA201270
ndc (package): 80425-0346-2
ndc (package): 80425-0346-3
ndc (package): 80425-0346-1
ndc (package): 80425-0346-4
ndc (product): 80425-0346
ndc11 (package): 80425034601
rxcui: 197580
spl id: 4250a0b0-e539-57c9-e063-6294a90a4b55
spl set id: 01cfaa3e-5e30-18fa-e063-6394a90a084e
unii: 7S5I7G3JQL
MaxitrolNEOMYCIN SULFATE, POLYMYXIN B SULFATE AND DEXAMETHASONEHarrow Eye, LLCecfb954f-5554-0ad2-e053-2995a90a75162025-10-24Warnings, Adverse reactionsExact identifier
unii: 7S5I7G3JQL
DEXAMETHASONEDEXAMETHASONEAdvagen Pharma Ltd.3c1729db-8ba3-4cba-9eff-ab4ae2c061c22025-10-22Warnings, Adverse reactionsExact identifier
rxcui: 197580
unii: 7S5I7G3JQL
TOBRAMYCIN AND DEXAMETHASONETOBRAMYCIN AND DEXAMETHASONEBryant Ranch Prepack3e541ebf-2f7e-4cc0-9928-780353aa76572025-10-21Warnings, Adverse reactionsExact identifier
unii: 7S5I7G3JQL
TOBRAMYCIN AND DEXAMETHASONETOBRAMYCIN AND DEXAMETHASONEBryant Ranch Prepack3e5cd7f9-1f88-4d33-be25-c362de4dc87b2025-10-21Warnings, Adverse reactionsExact identifier
unii: 7S5I7G3JQL
TOBRAMYCIN AND DEXAMETHASONETOBRAMYCIN AND DEXAMETHASONEBryant Ranch Prepack15280680-edc0-4e5d-99ee-117a6f5893072025-10-21Warnings, Adverse reactionsExact identifier
unii: 7S5I7G3JQL
Sugar CravingsCINNAMIC ACID, PHLORIDZINUM, ARGENTUM NITRICUM, ADENOSINUM TRIPHOSPHORICUM DINATRUM, BEET SUGAR, DEXTROSE, D-RIBOSE, FRUCTOSE, LYCOPODIUM CLAVATUM, MAPLE SUGAR, SACCHARUM LACTIS, SACCHARUM OFFICINALE, SARCOLACTICUM ACIDUM, MALVIN, ADRENOCORTICOTROPHIN, DYSENTERY BACILLUS, MORGAN GAERTNERDr. Donna Restivo DC401873ba-ae1b-4506-a2e8-c6c0e5ff27f52025-10-21WarningsExact identifier
unii: C151H8M554
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
application number: ANDA201270
rxcui: 197580
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
application number: ANDA201270
rxcui: 197580
unii: 7S5I7G3JQL
DexamethasoneDEXAMETHASONEApotex Corp.bfaa71cb-e517-8d94-f64b-8cdbf7b8fbf22025-09-17Warnings, Adverse reactionsExact identifier
rxcui: 197580
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

Reported adverse events (FAERS/openFDA)#

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