FDA.reportPublic FDA data

NDC 80425-0087-01 - 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
80425-0087
Requested NDC
80425-0087-01
Package NDCs from labels
80425-0087-2, 80425-0087-1, 80425-0087-01
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
Zolpidem Tartrate - 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
80425-0087-1Zolpidem Tartrate30 in 1 BOTTLETABLET, FILM COATED305
80425-0087-2Zolpidem Tartrate60 in 1 BOTTLETABLET, FILM COATED605

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0087ZOLPIDEM TARTRATE TABLET, FILM COATED [ADVANCED RX OF TENNESSEE, LLC]5Current NDC, Legacy NDC, 2 package rows20250101_b2db3979-daa6-6e83-e053-2a95a90a3a2f.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0087-1EA - Each80425-008715df0cb0-9354-4327-a0f8-409b7af96d8d12023-04-07
80425-0087-2EA - Each80425-008797f4a130-d9aa-404f-89f1-48fd2537d7ec12023-04-07

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 3 of 6 · 116 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Zolpidem TartrateZOLPIDEM TARTRATEProficient Rx LP92c58053-7ed8-4a3d-a2f7-8e30c4e5a3672025-06-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 854876
rxcui: 854873
unii: WY6W63843K
ZOLPIDEM TARTRATEZOLPIDEM TARTRATEAphena Pharma Solutions - Tennessee, LLC349053e4-9885-ec0b-e063-6294a90ad79a2025-05-23Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 854876
unii: WY6W63843K
ZolpidemZOLPIDEM TARTRATEAphena Pharma Solutions - Tennessee, LLC1e15d6e3-8d06-0936-e063-6394a90ab8db2025-05-22Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 854873
unii: WY6W63843K
Zolpidem TartrateZOLPIDEM TARTRATEAdvanced Rx of Tennessee, LLC3310d63e-d79a-175d-e063-6394a90a42702025-04-18Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 854876
unii: WY6W63843K
AmbienZOLPIDEM TARTRATESanofi-Aventis U.S. LLCc36cadf4-65a4-4466-b409-c82020b424522025-04-15Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 854876
rxcui: 854873
unii: WY6W63843K
ZOLPIDEM TARTRATEZOLPIDEM TARTRATEAsclemed USA, Inc.30c057fb-2e1b-4b9c-8c8a-79c322151e612025-04-11Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WY6W63843K
Zolpidem TartrateZOLPIDEM TARTRATEPreferred Pharmaceuticals Inc.d579c6ca-c820-49ff-92fb-2e6aaad3b0522025-04-11Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 854876
unii: WY6W63843K
ZOLPIDEM TARTRATEZOLPIDEM TARTRATEAsclemed USA, Inc.e5e2d31b-ce26-78b0-e053-2a95a90ac4912025-02-09Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 854876
rxcui: 854873
unii: WY6W63843K
AmbienZOLPIDEM TARTRATECosette Pharmaceuticals, Inc.747949c5-2c91-4909-8a07-71b6826f8e972025-02-07Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 854876
rxcui: 854873
unii: WY6W63843K
Ambien CRZOLPIDEM TARTRATECosette Pharmaceuticals, Inc.2d934da3-bd77-4470-e063-6294a90a64f52025-02-07Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WY6W63843K
Zolpidem TartrateZOLPIDEM TARTRATEPD-Rx Pharmaceuticals, Inc.38c838a4-9943-445a-8e80-e823d56eeaa52025-01-30Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA078413
rxcui: 854876
unii: WY6W63843K
Zolpidem TartrateZOLPIDEM TARTRATEPD-Rx Pharmaceuticals, Inc.fda413e7-b1ae-312a-e053-6394a90ab2c62025-01-22Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA078413
rxcui: 854873
unii: WY6W63843K
ZOLPIDEM TARTRATEZOLPIDEM TARTRATEDIRECT RXc3f23bc3-595b-28e5-e053-2a95a90a9c2c2025-01-20Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WY6W63843K
Zolpidem TartrateZOLPIDEM TARTRATENuCare Pharmaceuticals, Inc.2b9f696a-b637-4dea-e063-6394a90aeb2e2025-01-13Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA078413
rxcui: 854873
unii: WY6W63843K
Zolpidem TartrateZOLPIDEM TARTRATEAdvanced Rx of Tennessee, LLCaf87ae17-a3c5-a3a5-e053-2a95a90aa4b02024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 854873
unii: WY6W63843K
Zolpidem TartrateZOLPIDEM TARTRATEAdvanced Rx of Tennessee, LLCaf87b722-cdb7-0b17-e053-2a95a90a315b2024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 854873
unii: WY6W63843K
Zolpidem TartrateZOLPIDEM TARTRATEAdvanced Rx of Tennessee, LLCaf87df4e-2c97-e23e-e053-2a95a90ab3542024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA078413
rxcui: 854873
unii: WY6W63843K
Zolpidem TartrateZOLPIDEM TARTRATEAdvanced Rx of Tennessee, LLCb2db3979-daa6-6e83-e053-2a95a90a3a2f2024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA078413
ndc (package): 80425-0087-2
ndc (package): 80425-0087-1
ndc (product): 80425-0087
ndc11 (package): 80425008701
rxcui: 854876
spl id: 2a98ff70-0368-7169-e063-6394a90adc74
spl set id: b2db3979-daa6-6e83-e053-2a95a90a3a2f
unii: WY6W63843K
Zolpidem TartrateZOLPIDEM TARTRATEAdvanced Rx Pharmacy of Tennessee, LLCc8adec28-9dcd-4a7e-e053-2a95a90a991e2024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 854876
unii: WY6W63843K
Zolpidem TartrateZOLPIDEM TARTRATEAdvanced Rx Pharmacy of Tennessee, LLCc859c752-8a85-2017-e053-2a95a90a771f2024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA078413
rxcui: 854873
unii: WY6W63843K

Reported adverse events (FAERS/openFDA)#

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