FDA.reportPublic FDA data

NDC 43386-762-01 - 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
43386-762
Requested NDC
43386-762-01
Package NDCs from labels
43386-762-01, 43386-762-30
Manufacturer
Lupin Pharmaceuticals,Inc. | Novel Laboratories, Inc.
Effective date
2020-11-18
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
ZOLPIDEM TARTRATE - Lupin Pharmaceuticals,Inc. | Novel Laboratories, Inc.Lupin Pharmaceuticals,Inc. | Novel Laboratories, Inc.2020-11-18HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43386-762-01ZOLPIDEM TARTRATE1 in 1 BLISTER PACKTABLET16
43386-762-01ZOLPIDEM TARTRATE1 in 1 POUCHTABLET16
43386-762-30ZOLPIDEM TARTRATE30 in 1 CARTONTABLET306

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43386-762ZOLPIDEM TARTRATE TABLET [LUPIN PHARMACEUTICALS,INC.]6Current NDC, Legacy NDC, 3 package rows20201119_6db679f6-b1f8-4fbf-9e87-9cef4650c45a.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43386-762-01EA - Each43386-7624be89bd4-4a1c-45bb-8486-7834ddbbe15f12019-02-13
43386-762-30EA - Each43386-762ccf4d3fa-09a8-4f9c-8fbe-7c77ebbcaf5b12016-04-04

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 33 of 54 · 1,079 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Zolpidem TartrateZOLPIDEM TARTRATEAdvanced Rx of Tennessee, LLCaf87ae17-a3c5-a3a5-e053-2a95a90aa4b02024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WY6W63843K
Zolpidem TartrateZOLPIDEM TARTRATEAdvanced Rx of Tennessee, LLCaf87b722-cdb7-0b17-e053-2a95a90a315b2024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WY6W63843K
Zolpidem TartrateZOLPIDEM TARTRATEAdvanced Rx of Tennessee, LLCaf87df4e-2c97-e23e-e053-2a95a90ab3542024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WY6W63843K
Zolpidem TartrateZOLPIDEM TARTRATEAdvanced Rx of Tennessee, LLCb2db3979-daa6-6e83-e053-2a95a90a3a2f2024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WY6W63843K
Zolpidem TartrateZOLPIDEM TARTRATEAdvanced Rx Pharmacy of Tennessee, LLCc8adec28-9dcd-4a7e-e053-2a95a90a991e2024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WY6W63843K
Zolpidem TartrateZOLPIDEM TARTRATEAdvanced Rx Pharmacy of Tennessee, LLCc859c752-8a85-2017-e053-2a95a90a771f2024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WY6W63843K
Zolpidem TartrateZOLPIDEM TARTRATEAdvanced Rx Pharmacy of Tennessee, LLCfc76ab4c-3607-39c3-e053-6394a90a68772024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WY6W63843K
Zolpidem TartrateZOLPIDEM TARTRATEAdvanced Rx Pharmacy of Tennessee, LLCf939549f-14a6-d37c-e053-6294a90a034a2024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WY6W63843K
EsteemAGNUS CASTUS, AMBRA GRISEA, ANACARDIUM ORIENTALE, AURUM METALLICUM, BARYTA IODATA, CANDIDA ALBICANS, CARCINOSIN, CUBEBA OFFICINALIS, HYPOTHALAMUS SUIS, LAC CANINUM, LILIUM TIGRINUM, LYCOPODIUM CLAVATUM, MAGNESIUM IODIDE, NAJA TRIPUDIANS, NATRUM CARBONICUM, RHUS GLABRA, ROSA DAMASCENA, SABADILLA, THUJA OCCIDENTALIS, VISCUM ALBUMDeseret Biologicals, Inc.f10cebe6-6ed1-45f7-80d4-f6c19fd8d0942024-12-30WarningsExact identifier
unii: 45P3261C7T
Trace Mineral CordARGENTUM METALLICUM, AURUM METALLICUM, BORON CITRATE, CALCAREA FLUORICA, CALCAREA PHOSPHORICA, CALCAREA SULPHURICA, CHROMIUM SULPHURICUM, COBALT GLUCONATE, CUPRUM SULPHURICUM, FERRUM PHOSPHORICUM, GERMANIUM SESQUIOXIDE, IODIUM, KALI BROMATUM, KALI MURIATICUM, KALI PHOSPHORICUM, KALI SULPHURICUM, LITHIUM CARBONICUM, MAGNESIA PHOSPHORICA, MANGANUM MURIATICUM, NATRUM MURIATICUM, NATRUM PHOSPHORICUM, NATRUM SULPHURICUM, SELENIUM METALLICUM, SILICEA, SODIUM MOLYBDATE, STRONTIUM CARBONICUM, VANADIUM METALLICUM,Energique, Inc.902dd68d-5ce1-481e-8938-6487dcc68dfc2024-12-19WarningsExact identifier
unii: ETJ7Z6XBU4
EcoDent Ultimate Essential Mouthcare Sparkling Clean MintSODIUM BICARBONATELotus Brands, Inc.4a95c8c1-db7c-4791-ac58-3eac216a01262024-12-18WarningsExact identifier
unii: 8MDF5V39QO
EcoDent Ultimate Essential Mouthcare Spicy-Cool CinnamonSODIUM BICARBONATELotus Brands, Inc.6703b29d-cdc9-4c74-91c0-fb0c98dd043e2024-12-18WarningsExact identifier
unii: 8MDF5V39QO
Equaline Effervescent Antacid and Pain ReliefASPIRIN, CITRIC ACID, SODIUM BICARBONATEUnited Natural Foods, Inc. dba UNFI739237a5-cc62-8ad6-e053-2991aa0a91f82024-12-17WarningsExact identifier
unii: 8MDF5V39QO
ZOLPIDEM TARTRATEZOLPIDEM TARTRATELake Erie Medical DBA Quality Care Products LLCdb735db9-1c82-4d32-bf91-97b05a75e8762024-12-17Warnings, Adverse reactionsExact identifier
unii: WY6W63843K
Alka-Seltzer Heartburn and PainANHYDROUS CITRIC ACID, ASPIRIN, AND SODIUM BICARBONATEBayer HealthCare LLC.2928e140-c868-5bf5-e063-6394a90ab0242024-12-13WarningsExact identifier
unii: 8MDF5V39QO
Rite Aid Antacid and Pain ReliefASPIRIN, CITRIC ACID, SODIUM BICARBONATERite Aidb4797380-9cef-d640-e053-2a95a90a06652024-12-11WarningsExact identifier
unii: 8MDF5V39QO
Top Value Effervescent Pain ReliefASPIRIN, CITRIC ACID, SODIUM BICAROBONATETower Laboratories Ltd44babed8-cf38-1c12-e054-00144ff8d46c2024-12-11Warnings, Adverse reactionsExact identifier
unii: 8MDF5V39QO
Best Choice Effervescent Antacid Pain ReliefASPIRIN, CITRIC ACID, SODIUM BICARBONATEValu Merchandisers Companyb5e2300a-b77b-53cc-e053-2a95a90a7a6e2024-12-11WarningsExact identifier
unii: 8MDF5V39QO
GeovitaCEREBRUM, CUPRUM MET, FERRUM MET, FORMICUM ACIDUM, SILICEARUBIMED AG0fcb5c06-d414-456c-a0ef-28e14018a7812024-11-29WarningsExact identifier
unii: ETJ7Z6XBU4
Para-SiJUGLANS REG, ABROTANUM, AESCULUS HIPP, ALLIUM SAT, ARSENICUM ALB, ARTEMISIA, BAPTISIA, CINA, CUPRUM MET, FILIX MAS, GRANATUM, IPECAC, LACHESIS, LYCOPODIUM, MERC VIV, NAPHTHALINUM, NAT MUR, NUX VOM, PULSATILLA, RATANHIA, RUTA, SABADILLA, SANTONINUM, SILICEA, SPIGELIA ANTH, TEREBINTHINA, TEUCRIUM MAR, THYMOLUM, ZINGIBERNewton Laboratories, Inc.27d41602-9dcb-eaa8-e063-6394a90a7cfa2024-11-26WarningsExact identifier
unii: ETJ7Z6XBU4

Reported adverse events (FAERS/openFDA)#

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