FDA.reportPublic FDA data

NDC 80425-0322-01 - Zolpidem Tartrate

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
80425-0322
Requested NDC
80425-0322-01
Package NDCs from labels
80425-0322-1, 80425-0322-2, 80425-0322-3, 80425-0322-01
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
Zolpidem Tartrate - 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
80425-0322-1Zolpidem Tartrate30 in 1 BOTTLETABLET302
80425-0322-2Zolpidem Tartrate60 in 1 BOTTLETABLET602
80425-0322-3Zolpidem Tartrate90 in 1 BOTTLETABLET902

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0322ZOLPIDEM TARTRATE TABLET [ADVANCED RX PHARMACY OF TENNESSEE, LLC]2Current NDC, 3 package rows20250102_f939549f-14a6-d37c-e053-6294a90a034a.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0322-1EA - Each80425-032267bf9b0c-76fe-4222-87be-ba092638fd6212023-06-06
80425-0322-2EA - Each80425-032211454b93-1801-400d-b75b-4a6ecb88add312023-06-06
80425-0322-3EA - Each80425-0322baa187af-aa39-4d13-8615-c0df83268b8d12023-06-06

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 4 of 6 · 116 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Zolpidem TartrateZOLPIDEM TARTRATEAdvanced Rx Pharmacy of Tennessee, LLCfc76ab4c-3607-39c3-e053-6394a90a68772024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA077903
rxcui: 854873
unii: WY6W63843K
Zolpidem TartrateZOLPIDEM TARTRATEAdvanced Rx Pharmacy of Tennessee, LLCf939549f-14a6-d37c-e053-6294a90a034a2024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA077903
ndc (package): 80425-0322-3
ndc (package): 80425-0322-1
ndc (package): 80425-0322-2
ndc (product): 80425-0322
ndc11 (package): 80425032201
rxcui: 854876
spl id: 2a9bfe6a-6d6f-b262-e063-6294a90a1cf3
spl set id: f939549f-14a6-d37c-e053-6294a90a034a
unii: WY6W63843K
ZOLPIDEM TARTRATEZOLPIDEM TARTRATELake Erie Medical DBA Quality Care Products LLCdb735db9-1c82-4d32-bf91-97b05a75e8762024-12-17Warnings, Adverse reactionsExact identifier
application number: ANDA077903
rxcui: 854873
unii: WY6W63843K
Zolpidem TartrateZOLPIDEM TARTRATEA-S Medication Solutions3ba3c29f-3835-4f4f-a39f-56fb42686f5b2024-11-13Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 854876
unii: WY6W63843K
Zolpidem tartrateZOLPIDEM TARTRATEBryant Ranch Prepack82bca7a0-021f-4e35-8b3f-6390eeb863a62024-10-29Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WY6W63843K
ZOLPIDEM TARTRATEZOLPIDEM TARTRATENuCare Pharmaceuticals,Inc.95b0ba48-4e71-25f7-e053-2a95a90aea822024-10-22Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA077903
rxcui: 854873
unii: WY6W63843K
ZolpidemZOLPIDEM TARTRATEAphena Pharma Solutions - Tennessee, LLC1e13ad50-f846-813a-e063-6294a90a58782024-09-29Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 854876
unii: WY6W63843K
Zolpidem TartrateZOLPIDEM TARTRATESandoz Inc0553e26c-f2aa-43aa-adf9-6eb951a501d32024-09-10Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 854876
rxcui: 854873
unii: WY6W63843K
Zolpidem tartrateZOLPIDEM TARTRATEBryant Ranch Prepackce301d8b-0a8c-4404-8697-57222ae17a442024-09-05Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WY6W63843K
ZolpidemZOLPIDEM TARTRATEBryant Ranch Prepack8cef5718-c562-43c3-8abe-a2fc5235ad2a2024-09-03Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 854876
unii: WY6W63843K
ZolpidemZOLPIDEM TARTRATEBryant Ranch Prepackfff2e7fc-2f7e-43c9-bfb3-d929ecc9eb722024-09-03Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 854876
unii: WY6W63843K
Zolpidem TartrateZOLPIDEM TARTRATEAmerican Health Packagingeb850154-4b4b-4d9a-8476-aea1a93fe8d72024-09-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 854876
unii: WY6W63843K
Zolpidem TartrateZOLPIDEM TARTRATEChartwell RX, LLC0dd113e1-f789-48d2-8cb2-d39b712736582024-08-28Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 854876
rxcui: 854873
unii: WY6W63843K
ZOLPIDEM TARTRATEZOLPIDEM TARTRATEBryant Ranch Prepack3bbc3c35-2811-4a67-9dcc-5eed38ef8b522024-08-28Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA077903
rxcui: 854873
unii: WY6W63843K
Zolpidem TartrateZOLPIDEM TARTRATEBryant Ranch Prepackf9c108d1-5e2f-41c7-a845-2aed48c309052024-08-28Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 854876
unii: WY6W63843K
ZOLPIDEM TARTRATEZOLPIDEM TARTRATEBryant Ranch Prepack604e77ef-2cda-4efc-abfb-9af549d40fd42024-08-28Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WY6W63843K
ZolpidemZOLPIDEM TARTRATEBryant Ranch Prepack74c4e793-3444-4d3d-8211-26374349ab1e2024-08-28Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 854873
unii: WY6W63843K
ZolpidemZOLPIDEM TARTRATEAdvanced Rx of Tennessee, LLC1fa86b79-8809-35f4-e063-6394a90a43772024-08-13Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 854876
unii: WY6W63843K
ZOLPIDEM TARTRATEZOLPIDEM TARTRATENuCare Pharmaceuticals,Inc.ac8c412a-0f94-7c3a-e053-2995a90afdc72024-07-17Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA077903
rxcui: 854876
unii: WY6W63843K
ZOLPIDEM TARTRATEZOLPIDEM TARTRATENuCare Pharmaceuticals, Inc4be6ce23-e7b1-510e-e054-00144ff8d46c2024-07-16Warnings, Adverse reactionsExact identifier
application number: ANDA077903
rxcui: 854873
unii: WY6W63843K

Reported adverse events (FAERS/openFDA)#

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