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 4 of 4 · 77 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AlprazolamALPRAZOLAMProficient Rx LP10de2b3b-3b3f-4a5a-a9e7-a8401f53b8cc2023-08-04Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197321
unii: YU55MQ3IZY
AlprazolamALPRAZOLAMANI Pharmaceuticals, Inc.38428a1b-718c-49cc-94ae-2e3644ba62562023-06-28Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197321
rxcui: 308047
rxcui: 197322
rxcui: 308048
unii: YU55MQ3IZY
Alprazolam Extended ReleaseALPRAZOLAMBryant Ranch Prepack4f6e4656-689f-46a6-a8ed-54ee555833572023-05-08Boxed warning, Warnings, Adverse reactionsExact identifier
unii: YU55MQ3IZY
AlprazolamALPRAZOLAMAphena Pharma Solutions - Tennessee, LLC54c790c5-2e6c-439d-8e3b-7502c962a5962023-03-20Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA074112
rxcui: 308047
unii: YU55MQ3IZY
AlprazolamALPRAZOLAMHikma Pharmaceuticals USA Inc.b945ac6f-796e-41ef-85e9-61007e4a4e9a2023-01-18Boxed warning, Warnings, Adverse reactionsExact identifier
unii: YU55MQ3IZY
XanaxALPRAZOLAMPHARMACIA & UPJOHN COMPANY LLC388e249d-b9b6-44c3-9f8f-880eced0239f2023-01-18Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197321
rxcui: 308047
rxcui: 197322
rxcui: 308048
unii: YU55MQ3IZY
AlprazolamALPRAZOLAMActavis Pharma, Inc.a23063c0-099a-4256-b95f-3a857bbf704b2023-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197321
rxcui: 308047
rxcui: 197322
rxcui: 308048
unii: YU55MQ3IZY
AlprazolamALPRAZOLAMActavis Pharma, Inc.5ceed721-2e65-4c81-bd84-f110b1ac9d2e2022-12-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: YU55MQ3IZY
AlprazolamALPRAZOLAMProficient Rx LP4579facb-b225-4108-a5ef-dada926ef7cf2022-04-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 308048
unii: YU55MQ3IZY
AlprazolamALPRAZOLAMProficient Rx LP34631dbf-f817-484d-8bcf-f8efa07178d72021-01-01Warnings, Adverse reactionsExact identifier
unii: YU55MQ3IZY
AlprazolamALPRAZOLAMProficient Rx LP969acb29-3b5c-47ed-8f7d-a960a24e72e32021-01-01Warnings, Adverse reactionsExact identifier
unii: YU55MQ3IZY
AlprazolamALPRAZOLAMProficient Rx LP717ce509-f92e-4ec1-a3c6-aeae54d56f4d2020-08-01Warnings, Adverse reactionsExact identifier
application number: ANDA074112
rxcui: 197321
rxcui: 197322
rxcui: 308048
unii: YU55MQ3IZY
AlprazolamALPRAZOLAMProficient Rx LP447efe78-3696-481c-bbae-23199a39ec942019-11-01Warnings, Adverse reactionsExact identifier
application number: ANDA074112
rxcui: 308047
unii: YU55MQ3IZY
AlprazolamALPRAZOLAMProficient Rx LPf6990b57-7011-4cdf-8abc-1794e2e0c7f12019-11-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197322
unii: YU55MQ3IZY
AlprazolamALPRAZOLAMAphena Pharma Solutions - Tennessee, LLC29ddd9f2-c116-467b-8db3-38166482aea02018-08-23Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197321
unii: YU55MQ3IZY
AlprazolamALPRAZOLAMAphena Pharma Solutions - Tennessee, LLC2717699a-c8b6-4590-937a-cb86eadc52962018-08-23Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 308047
unii: YU55MQ3IZY
AlprazolamALPRAZOLAMAphena Pharma Solutions - Tennessee, LLC964d7f43-34a6-45af-a95f-3b9ade17c6a52018-02-05Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197321
rxcui: 308047
rxcui: 308048
unii: YU55MQ3IZY

Reported adverse events (FAERS/openFDA)#

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