FDA.reportPublic FDA data

NDC 80425-0165-01 - 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
80425-0165
Requested NDC
80425-0165-01
Package NDCs from labels
80425-0165-2, 80425-0165-1, 80425-0165-01
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
80425-0165-1Zolpidem Tartrate30 in 1 BOTTLETABLET306
80425-0165-2Zolpidem Tartrate60 in 1 BOTTLETABLET606

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0165ZOLPIDEM TARTRATE TABLET [ADVANCED RX PHARMACY OF TENNESSEE, LLC]6Current NDC, Legacy NDC, 2 package rows20250101_c8adec28-9dcd-4a7e-e053-2a95a90a991e.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0165-1EA - Each80425-0165215b9b33-d708-447a-ab6d-31cbb6a576ae12023-04-07
80425-0165-2EA - Each80425-01650997c634-f082-437d-9429-ffccdb0fc98612023-04-07

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 5 of 6 · 116 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ZOLPIDEM TARTRATEZOLPIDEM TARTRATEDirectRX25f1176d-5195-1a99-e054-00144ff8d46c2024-06-26Warnings, Adverse reactionsExact identifier
application number: ANDA077903
rxcui: 854873
unii: WY6W63843K
ZOLPIDEM TARTRATEZOLPIDEM TARTRATENuCare Pharmaceuticals,Inc.98e5208b-5109-58c6-e053-2995a90a994a2024-06-20Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA077903
rxcui: 854873
unii: WY6W63843K
ZOLPIDEM TARTRATEZOLPIDEM TARTRATENuCare Pharmaceuticals,Inc.92c6cc45-c28b-729b-e053-2a95a90a7ccb2024-06-19Warnings, Adverse reactionsExact identifier
application number: ANDA077903
rxcui: 854873
unii: WY6W63843K
ZOLPIDEM TARTRATEZOLPIDEM TARTRATENuCare Pharmaceuticals,Inc.78481108-4a1c-fce9-e053-2a91aa0a09ad2024-06-12Warnings, Adverse reactionsExact identifier
application number: ANDA077903
rxcui: 854876
unii: WY6W63843K
ZOLPIDEM TARTRATEZOLPIDEM TARTRATEAphena Pharma Solutions - Tennessee, LLC1a8a8072-39bf-44c5-e063-6294a90a77c32024-06-10Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WY6W63843K
Zolpidem tartrateZOLPIDEM TARTRATESandoz Incb1b0085f-d9fe-430a-9bd5-607f607bf7e12024-06-03Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WY6W63843K
ZOLPIDEM TARTRATEZOLPIDEM TARTRATEAphena Pharma Solutions - Tennessee, LLC08411424-e8a8-4964-bd04-5b0b5aa5baaf2024-04-12Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WY6W63843K
ZolpidemZOLPIDEM TARTRATEBryant Ranch Prepack70d7cfc3-7e54-4cd8-8911-7cf115d5c8202024-04-05Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 854876
unii: WY6W63843K
ZolpidemZOLPIDEM TARTRATEBryant Ranch Prepack23bce69d-7918-42c2-8020-e22f292ff31f2024-04-05Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 854873
unii: WY6W63843K
ZolpidemZOLPIDEM TARTRATEBryant Ranch Prepack3aa7e88b-7929-45ac-9e81-03f4abf28e942024-04-04Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 854873
unii: WY6W63843K
ZolpidemZOLPIDEM TARTRATEBryant Ranch Prepack1e5b61b6-a5bd-4f09-9d34-905ce32f18992024-04-03Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 854873
unii: WY6W63843K
Zolpidem TartrateZOLPIDEM TARTRATEAurobindo Pharma Limitedea2067bd-1622-4d98-8012-2c09405aa88d2024-01-30Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 854876
rxcui: 854873
unii: WY6W63843K
Zolpidem TartrateZOLPIDEM TARTRATENorthStar Rx LLC51c9a29c-a285-40d0-bf3a-7e8c944ee39c2024-01-30Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 854876
rxcui: 854873
unii: WY6W63843K
Zolpidem TartrateZOLPIDEM TARTRATEAphena Pharma Solutions - Tennessee, LLC39d91478-ea0e-407e-b5cb-0eeb592e0aa42024-01-23Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WY6W63843K
ZolpidemZOLPIDEM TARTRATEBryant Ranch Prepackdf130798-1458-455b-a4e1-c33c4ecee43b2023-12-27Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 854876
unii: WY6W63843K
ZolpidemZOLPIDEM TARTRATEBryant Ranch Prepack33094305-4bbd-4b52-9079-8853d5f836822023-12-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 854873
unii: WY6W63843K
ZolpidemZOLPIDEM TARTRATEACI Healthcare USA, Inc021153ce-fe27-4ed1-8d88-b4157b0ed7342023-11-16Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 854876
rxcui: 854873
unii: WY6W63843K
Zolpidem TartrateZOLPIDEM TARTRATESun Pharmaceutical Industries, Inc.0c64bc71-2e7f-4b15-a8e1-acb8de04395f2023-10-18Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WY6W63843K
ZOLPIDEM TARTRATEZOLPIDEM TARTRATEA-S Medication Solutionse68a1b3b-b3d1-495e-be46-466113e7dbd62023-09-14Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA077903
rxcui: 854873
unii: WY6W63843K
Zolpidem TartrateZOLPIDEM TARTRATEA-S Medication Solutions67cc924a-26e0-431f-9160-32c9d92a46cd2023-02-04Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 854873
unii: WY6W63843K

Reported adverse events (FAERS/openFDA)#

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