FDA.reportPublic FDA data

NDC 80425-0061-01 - 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
80425-0061
Requested NDC
80425-0061-01
Package NDCs from labels
80425-0061-3, 80425-0061-2, 80425-0061-1, 80425-0061-01
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
80425-0061-1Zolpidem Tartrate30 in 1 BOTTLETABLET, FILM COATED307
80425-0061-2Zolpidem Tartrate60 in 1 BOTTLETABLET, FILM COATED607
80425-0061-3Zolpidem Tartrate90 in 1 BOTTLETABLET, FILM COATED907

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0061ZOLPIDEM TARTRATE TABLET, FILM COATED [ADVANCED RX OF TENNESSEE, LLC]7Current NDC, Legacy NDC, 3 package rows20250101_af87df4e-2c97-e23e-e053-2a95a90ab354.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0061-1EA - Each80425-00619a8e1311-7248-4dde-bd8e-2a42e3c7275612023-04-07
80425-0061-2EA - Each80425-006129fc5b47-c5e9-45b8-a096-128c54dbd7e212023-04-07
80425-0061-3EA - Each80425-00616123530f-5e41-4687-a0dc-305263602ead12023-04-07

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 1 of 6 · 117 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ZOLPIDEM TARTRATEZOLPIDEM TARTRATETorrent Pharmaceuticals Limited1584bad1-7bf4-4805-bdd9-7eb0fac927212026-09-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 854876
rxcui: 854873
unii: WY6W63843K
Zolpidem TartrateZOLPIDEM TARTRATEBreckenridge Pharmaceutical, Inc.cbda91f7-4411-4016-80d6-0a349931956d2026-08-26Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WY6W63843K
ZOLPIDEM TARTRATEZOLPIDEM TARTRATEA-S Medication Solutions59cc61da-838e-4add-b2d6-42b2b283a0002026-08-20Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 854876
rxcui: 854873
unii: WY6W63843K
ZOLPIDEM TARTRATEZOLPIDEM TARTRATEBryant Ranch Prepack413b6f65-101e-e2cf-0802-711d080b851b2026-08-06Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 854876
unii: WY6W63843K
ZOLPIDEM TARTRATEZOLPIDEM TARTRATEREMEDYREPACK INC.2abdcf77-d3ed-42bc-acd9-545aab75d5672026-07-30Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 854876
unii: WY6W63843K
ZOLPIDEM TARTRATEZOLPIDEM TARTRATESt. Mary's Medical Park Pharmacy507225e2-80ba-18c4-e054-00144ff88e882026-07-17Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 854873
unii: WY6W63843K
Zolpidem TartrateZOLPIDEM TARTRATETORRENT PHARMACEUTICALS LIMITED9025a6f7-5501-4aba-875e-222ef39848c02026-07-15Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WY6W63843K
Zolpidem TartrateZOLPIDEM TARTRATEBryant Ranch Prepack90201886-86a5-4c59-a4f1-98270d6207312026-07-07Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WY6W63843K
ZOLPIDEM TARTRATEZOLPIDEM TARTRATEBryant Ranch Prepackbf99cd5c-9671-45a6-bda9-3dfc8252efdd2026-07-07Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WY6W63843K
ZOLPIDEM TARTRATEZOLPIDEM TARTRATESt. Mary's Medical Park Pharmacy89cfb1d5-437c-4c13-8f9b-b6851ffba87b2026-06-30Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 854876
unii: WY6W63843K
Zolpidem TartrateZOLPIDEM TARTRATEREMEDYREPACK INC.cf3dcbde-b92a-4802-98e4-14f00abdf99e2026-06-09Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA078413
rxcui: 854873
unii: WY6W63843K
ZOLPIDEM TARTRATEZOLPIDEM TARTRATESt. Mary's Medical Park Pharmacy21767f56-ce92-2b8c-e063-6394a90a8b762026-06-04Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WY6W63843K
Zolpidem TartrateZOLPIDEM TARTRATEUmedica Laboratories USA Inc.b49f6c18-e155-4728-a79a-9354e8c3c8f42026-05-26Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WY6W63843K
ZOLPIDEM TARTRATEZOLPIDEM TARTRATEGolden State Medical Supply, Inc.2b5cf535-ccdc-ecd7-e063-6394a90a726e2026-04-29Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 854876
rxcui: 854873
unii: WY6W63843K
Zolpidem TartrateZOLPIDEM TARTRATEREMEDYREPACK INC.0f8488f3-851d-4111-af23-60f420aad0d62026-04-15Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 854873
unii: WY6W63843K
Zolpidem tartrate sublingualZOLPIDEM TARTRATE SUBLINGUALPar Health USA, LLC44b34e58-114b-4774-9fab-4b188dfe02282026-04-15Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WY6W63843K
ZOLPIDEM TARTRATEZOLPIDEM TARTRATEThe ACME Laboratories Ltd.5679ed64-8424-4e63-a3c9-91d80fff2ca62026-03-04Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 854876
rxcui: 854873
unii: WY6W63843K
ZOLPIDEM TARTRATEZOLPIDEM TARTRATENuCare Pharmaceuticals,Inc.bca751bb-5161-5a95-e053-2a95a90aa2dd2026-02-19Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WY6W63843K
Zolpidem TartrateZOLPIDEM TARTRATEA-S Medication Solutions2556c804-7a5e-4dbd-aeef-a3ba3a247c392026-01-23Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA078413
rxcui: 854873
unii: WY6W63843K
Zolpidem TartrateZOLPIDEM TARTRATEA-S Medication Solutionsf67ef513-1b2c-42fe-bf33-4c7e9db191a32026-01-22Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA078413
rxcui: 854876
unii: WY6W63843K

Reported adverse events (FAERS/openFDA)#

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