FDA.reportPublic FDA data

NDC 80425-0284-01 - Alprazolam

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
80425-0284
Requested NDC
80425-0284-01
Package NDCs from labels
80425-0284-1, 80425-0284-2, 80425-0284-01
Manufacturer
Advanced Rx 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
Alprazolam - Advanced Rx of Tennessee, LLCAdvanced Rx of Tennessee, LLC2024-12-31HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80425-0284-1Alprazolam30 in 1 BOTTLETABLET302
80425-0284-2Alprazolam60 in 1 BOTTLETABLET602

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0284ALPRAZOLAM TABLET [ADVANCED RX OF TENNESSEE, LLC]2Current NDC, 2 package rows20250102_f667458d-ddda-4e9e-e053-2995a90adb5a.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0284-1EA - Each80425-02845684006d-beb4-4df8-a64d-542f946f079112023-06-06
80425-0284-2EA - Each80425-02849ed1816c-f11d-4bf1-9328-ef6379d10d9f12023-06-06

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 2 of 4 · 77 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AlprazolamALPRAZOLAMA-S Medication Solutions8ef75d22-4a7c-48d5-a532-5a43b8593e7c2026-01-23Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 308048
unii: YU55MQ3IZY
AlprazolamALPRAZOLAMNatco Pharma USA LLCb3c55877-2538-4892-bdb1-d618c643d29c2026-01-13Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197321
rxcui: 308047
rxcui: 197322
rxcui: 308048
unii: YU55MQ3IZY
AlprazolamALPRAZOLAMNorthwind Health Company, LLC25174ee5-a86e-ab97-e063-6394a90acd872025-12-26Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 308047
unii: YU55MQ3IZY
AlprazolamALPRAZOLAMAurobindo Pharma Limitedd2fd0b3e-9b78-44d0-82a6-96d6c62387502025-12-11Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197321
rxcui: 308047
rxcui: 197322
rxcui: 308048
unii: YU55MQ3IZY
AlprazolamALPRAZOLAMAurobindo Pharma Limited326fa31a-5420-429b-9f7f-170cb38f64bd2025-12-11Boxed warning, Warnings, Adverse reactionsExact identifier
unii: YU55MQ3IZY
AlprazolamALPRAZOLAMPD-Rx Pharmaceuticals, Inc.5040e1ed-32d6-4757-a0ee-b8240f3e7cf52025-10-09Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 308048
unii: YU55MQ3IZY
AlprazolamALPRAZOLAMPD-Rx Pharmaceuticals, Inc.2f16ff78-1262-4bb8-9a25-822c13c4746f2025-10-09Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197321
unii: YU55MQ3IZY
AlprazolamALPRAZOLAMAvPAK3fa14fa4-45a7-6ef4-e063-6394a90a1dcd2025-09-25Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197321
rxcui: 308047
rxcui: 308048
unii: YU55MQ3IZY
AlprazolamALPRAZOLAMA-S Medication Solutions3c0cb60f-1c3a-48a6-ad16-f143515484122025-07-10Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA074112
rxcui: 197321
rxcui: 308047
rxcui: 197322
unii: YU55MQ3IZY
Alprazolam C-IVALPRAZOLAM C-IVDirect_Rxf6dd0e94-4a79-769f-e053-6394a90a5ae62025-06-02Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 308048
unii: YU55MQ3IZY
AlprazolamALPRAZOLAMNuCare Pharmaceuticals, Inc.315b5782-969a-4324-e063-6394a90acf372025-03-27Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 308047
unii: YU55MQ3IZY
AlprazolamALPRAZOLAMNuCare Pharmaceuticals, Inc.315b8cf2-01a0-3f7d-e063-6394a90a39b52025-03-27Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 308048
unii: YU55MQ3IZY
AlprazolamALPRAZOLAMPD-Rx Pharmaceuticals, Inc.0ffcdbab-17e4-4395-8155-5b6ad00be6c22025-02-28Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA074112
rxcui: 197321
unii: YU55MQ3IZY
Alprazolam XRALPRAZOLAMMylan Pharmaceuticals Inc.1338d1c9-7c75-42ed-95f3-9eb1b6fc51d32025-02-11Boxed warning, Warnings, Adverse reactionsExact identifier
unii: YU55MQ3IZY
AlprazolamALPRAZOLAMDirect_Rxf77cfdd0-847d-4edd-e053-6394a90a91b72025-01-22Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197322
unii: YU55MQ3IZY
AlprazolamALPRAZOLAMMylan Pharmaceuticals Inc.13930c94-d83a-414f-be35-b1fef35f738d2025-01-15Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197321
rxcui: 308047
rxcui: 197322
rxcui: 308048
unii: YU55MQ3IZY
AlprazolamALPRAZOLAMNuCare Pharmaceuticals,Inc.02840ea6-e4a0-96a0-e063-6394a90a19ae2025-01-03Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 308047
unii: YU55MQ3IZY
AlprazolamALPRAZOLAMPD-Rx Pharmaceuticals, Inc.7538d0d0-346e-4c3e-8f7a-c1cac8ec8ed32025-01-02Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197322
unii: YU55MQ3IZY
AlprazolamALPRAZOLAMAdvanced Rx of Tennessee, LLCb39e2bc8-b68f-0f4e-e053-2995a90a00fd2024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 308048
unii: YU55MQ3IZY
AlprazolamALPRAZOLAMAdvanced Rx of Tennessee, LLCb4cd647f-1ba3-334e-e053-2995a90af3522024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197321
unii: YU55MQ3IZY

Reported adverse events (FAERS/openFDA)#

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