FDA.reportPublic FDA data

NDC 80425-0261-01 - Dexamethasone Sodium Phosphate

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
80425-0261
Requested NDC
80425-0261-01
Package NDCs from labels
80425-0261-1, 80425-0261-01
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 Sodium Phosphate - 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
80425-0261-1Dexamethasone Sodium Phosphate25 in 1 CARTONINJECTION252
80425-0261-1Dexamethasone Sodium Phosphate1 mL in 1 VIALINJECTION12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0261DEXAMETHASONE SODIUM PHOSPHATE INJECTION [ADVANCED RX PHARMACY OF TENNESSEE, LLC]2Current NDC, 2 package rows20250102_f4d6c7c8-7a77-6a46-e053-2995a90a4411.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0261-1ML - Milliliter80425-0261bdda6294-e6f3-4c0e-af06-ef6424be952412023-04-07

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 3 of 4 · 77 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dexamethasone Sodium PhosphateDEXAMETHASONE SODIUM PHOSPHATESomerset Therapeutics, LLC2dcbf312-6f4b-439a-8e2f-dda61eeb2cab2025-01-09Warnings, Adverse reactionsExact identifier
unii: AI9376Y64P
DEXAMETHASONE SODIUM PHOSPHATEDEXAMETHASONE SODIUM PHOSPHATEHF Acquisition Co LLC, DBA HealthFirst9a426a16-19f8-567e-e053-2a95a90a0a5b2025-01-08Warnings, Adverse reactionsExact identifier
unii: AI9376Y64P
DoubleDex KitDEXAMETHASONE SODIUM PHOSPHATE, POVIDINE IODINEAdvanced Rx Pharmacy of Tennessee, LLCfb85dd2c-6c90-6249-e053-6294a90a09fa2024-12-31Warnings, Adverse reactionsExact identifier
rxcui: 1812079
Dexamethasone Sodium PhosphateDEXAMETHASONE SODIUM PHOSPHATEAdvanced Rx Pharmacy of Tennessee, LLCf4d6c7c8-7a77-6a46-e053-2995a90a44112024-12-31Warnings, Adverse reactionsExact identifier
application number: ANDA207442
ndc (package): 80425-0261-1
ndc (product): 80425-0261
ndc11 (package): 80425026101
rxcui: 1812079
spl id: 2a9bad62-b2fd-697c-e063-6294a90aa395
spl set id: f4d6c7c8-7a77-6a46-e053-2995a90a4411
unii: AI9376Y64P
Dexamethasone Sodium PhosphateDEXAMETHASONE SODIUM PHOSPHATECivica, Inc.d54a27f2-2af8-4f86-a7fd-453f6b1a99972024-12-26Warnings, Adverse reactionsExact identifier
unii: AI9376Y64P
Dexamethasone Sodium PhosphateDEXAMETHASONE SODIUM PHOSPHATESomerset Therapeutics, LLC799028e2-c0e4-494f-89ff-1b786babc34a2024-12-19Warnings, Adverse reactionsExact identifier
application number: ANDA207442
ndc (product): 70069-021
rxcui: 1812079
spl id: 73618326-ff56-4a30-9d6d-6b019b61c2cd
spl set id: 799028e2-c0e4-494f-89ff-1b786babc34a
unii: AI9376Y64P
Dexamethasone Sodium PhosphateDEXAMETHASONE SODIUM PHOSPHATEFresenius Kabi USA, LLC4fedef4f-ec96-4f36-b2f0-01e243e3b89e2024-10-14Warnings, Adverse reactionsExact identifier
unii: AI9376Y64P
DEXAMETHASONE SODIUM PHOSPHATEDEXAMETHASONE SODIUM PHOSPHATEHF Acquisition Co LLC, DBA HealthFirstdf77fab1-f58c-46db-e053-2a95a90a54162024-10-08Warnings, Adverse reactionsExact identifier
unii: AI9376Y64P
RopidexDEXAMETHASONE SODIUM PHOSPHATE, ROPIVACAINE HYDROCHLORIDE, POVIDINE IODINEAsclemed USA, Inc.2577c1ba-8aff-4098-ba11-a375e9ce3caa2024-10-04Warnings, Adverse reactionsExact identifier
rxcui: 1812079
Dexamethasone Sodium PhosphateDEXAMETHASONE SODIUM PHOSPHATEAmneal Pharmaceuticals LLCddc82c42-2e6e-42a6-a30a-e41978e2f4da2024-08-14Warnings, Adverse reactionsExact identifier
unii: AI9376Y64P
Dexamethasone Sodium PhosphateDEXAMETHASONE SODIUM PHOSPHATEAmneal Pharmaceuticals LLCba18ba23-9ea3-4ce1-84ae-74e9151bb6a42024-07-29Warnings, Adverse reactionsExact identifier
rxcui: 1812079
unii: AI9376Y64P
Dexamethasone Sodium PhosphateDEXAMETHASONE SODIUM PHOSPHATEGland Pharma Limitedc9d9ab76-6bc6-433d-aad7-8d49064ed7452024-06-26Warnings, Adverse reactionsExact identifier
rxcui: 1812079
unii: AI9376Y64P
Dexamethasone Sodium PhosphateDEXAMETHASONE SODIUM PHOSPHATEPhlow Corporation02d25ab8-8f51-452b-b944-f569fbae36fe2024-06-25Warnings, Adverse reactionsExact identifier
unii: AI9376Y64P
DEXAMETHASONE SODIUM PHOSPHATEDEXAMETHASONE SODIUM PHOSPHATEHF Acquisition Co LLC, DBA HealthFirst18a70010-6cc5-19e2-e063-6394a90a0ea62024-05-28Warnings, Adverse reactionsExact identifier
unii: AI9376Y64P
Dexamethasone Sodium PhosphateDEXAMETHASONE SODIUM PHOSPHATEA-S Medication Solutionsd21f3055-8a8a-4797-93e2-c8f582cbdae12024-04-11Warnings, Adverse reactionsExact identifier
unii: AI9376Y64P
Dexamethasone Sodium PhosphateDEXAMETHASONE SODIUM PHOSPHATEMylan Institutional LLCdff598e8-e662-411f-978d-4ba3fb8ef7db2024-03-05Warnings, Adverse reactionsExact identifier
unii: AI9376Y64P
DEXAMETHASONE SODIUM PHOSPHATEDEXAMETHASONE SODIUM PHOSPHATEHF Acquisition Co LLC, DBA HealthFirst8e36534f-d64c-7e7b-e053-2995a90ad48e2024-01-30Warnings, Adverse reactionsExact identifier
unii: AI9376Y64P
DEXAMETHASONE SODIUM PHOSPHATEDEXAMETHASONE SODIUM PHOSPHATEHF Acquisition Co LLC, DBA HealthFirst7da9da65-0c03-23e2-e053-2a91aa0a042f2024-01-04Warnings, Adverse reactionsExact identifier
unii: AI9376Y64P
Dexamethasone Sodium PhosphateDEXAMETHASONE SODIUM PHOSPHATEMedical Purchasing Solutions, LLC69339a97-99dd-7297-e053-2991aa0a7fb82023-06-22Warnings, Adverse reactionsExact identifier
unii: AI9376Y64P
DEXAMETHASONE SODIUM PHOSPHATEDEXAMETHASONE SODIUM PHOSPHATEMedical Purchasing Solutions, LLC69346605-dff6-1958-e053-2a91aa0a0e1a2023-05-23Warnings, Adverse reactionsExact identifier
unii: AI9376Y64P

Reported adverse events (FAERS/openFDA)#

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