NDC 80425-0100-01 - 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
80425-0100
Requested NDC
80425-0100-01
Package NDCs from labels
80425-0100-2, 80425-0100-1, 80425-0100-01
Manufacturer
Advanced Rx Pharmacy of Tennessee, LLC
Effective date
2024-07-11
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Alprazolam - Advanced Rx Pharmacy of Tennessee, LLCAdvanced Rx Pharmacy of Tennessee, LLC2024-07-11HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80425-0100-1Alprazolam30 in 1 BOTTLETABLET307
80425-0100-2Alprazolam60 in 1 BOTTLETABLET607

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0100ALPRAZOLAM TABLET [ADVANCED RX PHARMACY OF TENNESSEE, LLC]7Current NDC, Legacy NDC, 2 package rows20240712_b39e2bc8-b691-0f4e-e053-2995a90a00fd.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0100-1EA - Each80425-01001bc798ae-2e69-4efa-b20e-0b9b2681b48b12024-08-12
80425-0100-2EA - Each80425-01007e0d1fd1-cf9b-4191-9d35-098800a7e2f612023-03-13

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
rxcui: 308048
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
ndc (package): 80425-0100-1
ndc (package): 80425-0100-2
ndc (product): 80425-0100
ndc11 (package): 80425010001
rxcui: 197321
spl id: 1cfab3cb-1866-f860-e063-6294a90a464d
spl set id: b39e2bc8-b691-0f4e-e053-2995a90a00fd
unii: YU55MQ3IZY
AlprazolamALPRAZOLAMSandoz Incd9b0e228-17cf-40d7-b62e-5050311c571c2024-05-31Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA074112
ndc (product): 0781-1079
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.