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 3 of 4 · 77 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AlprazolamALPRAZOLAMAdvanced Rx of Tennessee, LLCf667458d-ddda-4e9e-e053-2995a90adb5a2024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA074112
ndc (package): 80425-0284-1
ndc (package): 80425-0284-2
ndc (product): 80425-0284
ndc11 (package): 80425028401
rxcui: 308048
spl id: 2a9b9724-0255-e829-e063-6394a90a1c07
spl set id: f667458d-ddda-4e9e-e053-2995a90adb5a
unii: YU55MQ3IZY
AlprazolamALPRAZOLAMAmerican Health Packagingea95d182-453b-4c43-8402-d65c488d55f22024-12-30Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 308047
rxcui: 308048
unii: YU55MQ3IZY
AlprazolamALPRAZOLAMAdvanced Rx of Tennessee, LLC26f8b63c-6dad-8fac-e063-6394a90a54352024-11-06Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197321
unii: YU55MQ3IZY
AlprazolamALPRAZOLAMNuCare Pharmaceuticals,Inc.f7e63d96-2310-4ab1-e053-6294a90a86fc2024-09-03Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197321
unii: YU55MQ3IZY
AlprazolamALPRAZOLAMNuCare Pharmaceuticals,Inc.aaf7979c-168a-0da2-e053-2995a90a4d122024-07-17Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 308048
unii: YU55MQ3IZY
AlprazolamALPRAZOLAMNuCare Pharmaceuticals,Inc.b43df4ca-8d28-7b3a-e053-2a95a90aa4d72024-07-17Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 308047
unii: YU55MQ3IZY
AlprazolamALPRAZOLAMAdvanced Rx Pharmacy of Tennessee, LLCb39e2bc8-b691-0f4e-e053-2995a90a00fd2024-07-11Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA074112
rxcui: 197321
unii: YU55MQ3IZY
AlprazolamALPRAZOLAMSandoz Incd9b0e228-17cf-40d7-b62e-5050311c571c2024-05-31Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA074112
ndc (product): 0781-1077
rxcui: 197321
rxcui: 308047
rxcui: 197322
rxcui: 308048
spl id: 4c8c7366-aa3b-4124-9d64-67fb0ead6e15
spl set id: d9b0e228-17cf-40d7-b62e-5050311c571c
unii: YU55MQ3IZY
AlprazolamALPRAZOLAMBryant Ranch Prepack8ca8e0fc-6c3d-48d4-ad04-708182b453502024-05-24Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 308047
unii: YU55MQ3IZY
Alprazolam Extended ReleaseALPRAZOLAMBryant Ranch Prepack29477df1-68aa-44b3-bf9e-80ecff6ce8792024-05-17Boxed warning, Warnings, Adverse reactionsExact identifier
unii: YU55MQ3IZY
AlprazolamALPRAZOLAMBryant Ranch Prepack25781f50-d309-4c4f-9e21-c019e068d1012024-04-04Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 308048
unii: YU55MQ3IZY
AlprazolamALPRAZOLAMBryant Ranch Prepackb0000772-2514-45a2-a75d-1bbb13c299892024-04-04Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197322
unii: YU55MQ3IZY
AlprazolamALPRAZOLAMMedsource Pharmaceuticals14960c0c-555f-acc1-e063-6394a90a232a2024-03-26Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 308048
unii: YU55MQ3IZY
AlprazolamALPRAZOLAMAmneal Pharmaceuticals LLC259387c1-e374-4bc2-9510-5f7f2c60d1a52024-03-20Boxed warning, Warnings, Adverse reactionsExact identifier
unii: YU55MQ3IZY
AlprazolamALPRAZOLAMNuCare Pharmaceuticals,Inc.f9903822-642d-e364-e053-6394a90a22d82024-03-12Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197322
unii: YU55MQ3IZY
AlprazolamALPRAZOLAMAsclemed USA, Inc.e3245259-024f-4bd9-9ec6-94aa11febfd72024-01-11Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197321
rxcui: 308047
rxcui: 197322
rxcui: 308048
unii: YU55MQ3IZY
AlprazolamALPRAZOLAMAsclemed USA, Inc.5d839a8b-0f45-42bf-acc1-2bd28f948e532024-01-06Boxed warning, Warnings, Adverse reactionsExact identifier
unii: YU55MQ3IZY
AlprazolamALPRAZOLAMProficient Rx LP60c90b4b-174f-4fd2-b65f-fc166c16bdc12023-10-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 308047
unii: YU55MQ3IZY
AlprazolamALPRAZOLAMProficient Rx LP68e6ef8c-4104-4636-9719-6aa386c892d92023-10-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 308048
unii: YU55MQ3IZY
AlprazolamALPRAZOLAMAphena Pharma Solutions - Tennessee, LLCf95f4030-e8e0-416f-951d-c4dac09f386a2023-09-15Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA074112
rxcui: 308048
unii: YU55MQ3IZY

Reported adverse events (FAERS/openFDA)#

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