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 30 of 54 · 1,079 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PRIDICHTHAMMOL, CALCIUM SULFIDE, CALENDULA OFFICINALIS FLOWERING TOP, ARNICA MONTANA, ECHINACEA ANGUSTIFOLIA, SILICON DIOXIDE, SULFURHyland's Inc.d22eca2f-d7e6-3412-e053-2995a90a63842025-02-05WarningsExact identifier
unii: ETJ7Z6XBU4
Jacksons Cell Salts 12 IN 1CALC FLUOR, CALC PHOS, CALC SULPH, FERRUM PHOS, KALI MUR, KALI PHOS, KALI SULPH, MAG PHOS, NAT MUR, NAT PHOS, NAT SULPH, SILICEAZettl Health Inc.25ba49d0-0369-3666-e063-6294a90a71c42025-02-04Exact identifier
unii: ETJ7Z6XBU4
Jacksons Cell Salts SILICA 6X 12SILICEAZettl Health Inc.2d5d1bf7-3754-1f60-e063-6294a90aee062025-02-04Exact identifier
unii: ETJ7Z6XBU4
Well at WalgreensSODIUM BICARBONATE, SODIUM CHLORIDEWalgreen Companycb5d3d9d-2481-4303-b6af-0002de8c90652025-01-31WarningsExact identifier
unii: 8MDF5V39QO
Sinus Wash PacketSODIUM BICARBONATE, SODIUM CHLORIDERITE AID CORPORATIONd5b44ae7-81e8-1413-e053-2995a90a59332025-01-31WarningsExact identifier
unii: 8MDF5V39QO
Sinus Wash Saline Refills MeijerSODIUM BICARBONATE, SODIUM CHLORIDEMeijer, Inc.dd7465fe-503a-4e34-e053-2995a90a27782025-01-31WarningsExact identifier
unii: 8MDF5V39QO
SinuCleanseSODIUM BICARBONATE, SODIUM CHLORIDEASCENT CONSUMER PRODUCTS, INC.ff4df6c5-c85f-406a-89d7-8c2853fd5e102025-01-31WarningsExact identifier
unii: 8MDF5V39QO
CVSSODIUM BICARBONATE, SODIUM CHLORIDECVS Pharmacybccefef8-f92d-42fc-90fc-86644d1df6552025-01-31WarningsExact identifier
unii: 8MDF5V39QO
Well at WalgreensSODIUM BICARBONATE, SODIUM CHLORIDEWalgreen Companybcd336b4-9189-44d5-ae6d-81e535eff6b52025-01-31WarningsExact identifier
unii: 8MDF5V39QO
SinuCleanseSODIUM BICARBONATE, SODIUM CHLORIDEASCENT CONSUMER PRODUCTS, INC.c33bf872-54aa-45e0-9e40-a6565a13f1982025-01-31WarningsExact identifier
unii: 8MDF5V39QO
Sodium Bicarbonate 10 gr (650 mg)SODIUM BICARBONATECitraGen Pharmaceuticals Inc.650fa284-5829-588f-e053-2991aa0a9a0e2025-01-30WarningsExact identifier
unii: 8MDF5V39QO
Sodium Bicarbonate 5 gr (325 mg)SODIUM BICARBONATECitraGen Pharmaceuticals Inc.68aadbd9-f1c6-8a23-e053-2991aa0afd962025-01-30WarningsExact identifier
unii: 8MDF5V39QO
Zolpidem TartrateZOLPIDEM TARTRATEPD-Rx Pharmaceuticals, Inc.38c838a4-9943-445a-8e80-e823d56eeaa52025-01-30Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WY6W63843K
Tummy UpsetCHAMOMILLA, ECHINACEA, IRIS VERSICOLOR, RUTA GRAVEOLENS, TARAXACUM OFFICINALE, ALOE, ANGELICA SINENSIS RADIX, ANTIMONIUM , ARGENTUM NITRICUM, ARNICA MONTANA, ARSENICUM ALBUM, BAPTISIA TINCTORIA, BISMUTHUM METALLICUM, BRYONIA, CINCHONA OFFICINALIS, GRAPHITES, HYDRASTIS CANADENSIS, IPECACUANHA, LACHESIS MUTUS, LYCOPODIUM CLAVATUM, MYRRHA, NATRUM CARBONICUM, NUX VOMICA, PHOSPHORUS, PULSATILLA, ZINGIBER OFFICINALE.Newton Laboratories, Inc.9dc2da0a-0b3a-548e-e053-2995a90abe6d2025-01-28WarningsExact identifier
unii: 45P3261C7T
ConstipationECHINACEA, IRIS VERSICOLOR, PHYTOLACCA DECANDRA, TARAXACUM OFFICINALE, ABIES NIGRA, AESCULUS HIPPOCASTANUM, ALOE, ALUMINA, BRYONIA, CARBO VEGETABILIS, CHELIDONIUM MAJUS, COLLINSONIA CANADENSIS, GRAPHITE, HYDRASTIS CANADENSIS 15X, KALI CARBONICUM 15X, LYCOPODIUM CLAVATUM 15X, MAGNESIA MURIATICA 15X, MEZEREUM, NUX VOMICA, PODOPHYLLUM PELTATUM, RHAMNUS PURSHIANA, SANICULA, SELENIUM METALLICUM, SEPIA, SILICEA, TABACUM, VERATRUM ALBUM, ZINCUM METALLICUMNewton Laboratories, Inc.9d63b107-cd47-d9a5-e053-2a95a90a44932025-01-28WarningsExact identifier
unii: ETJ7Z6XBU4
Bestmade Natural Products BM55DAPHNE INDICA, NATRUM PHOS, SILICA MARINA, TABACUMBestmade Natural Products2c751942-5b36-8558-e063-6294a90af87a2025-01-24WarningsExact identifier
unii: ETJ7Z6XBU4
ConstipationECHINACEA, IRIS VERSICOLOR, PHYTOLACCA DECANDRA, TARAXACUM OFFICINALE, ABIES NIGRA, AESCULUS HIPPOCASTANUM, ALOE, ALUMINA, BRYONIA, CARBO VEGETABILIS, CHELIDONIUM MAJUS, COLLINSONIA CANADENSIS, GRAPHITE, HYDRASTIS CANADENSIS 15X, KALI CARBONICUM 15X, LYCOPODIUM CLAVATUM 15X, MAGNESIA MURIATICA 15X, MEZEREUM, NUX VOMICA, PODOPHYLLUM PELTATUM, RHAMNUS PURSHIANA, SANICULA, SELENIUM METALLICUM, SEPIA, SILICEA, TABACUM, VERATRUM ALBUM, ZINCUM METALLICUMNewton Laboratories, Inc.9d626292-7abb-1afb-e053-2995a90a28182025-01-24WarningsExact identifier
unii: ETJ7Z6XBU4
DOCTRUST K ToothSILICON DIOXIDE, SODIUM MONOFLUOROPHOSPHATEDOCSMEDI Co., Ltd.a02f8865-e7be-4ef4-b09c-dad8466397642025-01-22WarningsExact identifier
unii: ETJ7Z6XBU4
Bestmade Natural Products Bio4CALC FLUOR, KALI MUR, NAT MUR, SILICEABestmade Natural Productsea224687-106e-3821-e053-2995a90aa69c2025-01-22WarningsExact identifier
unii: ETJ7Z6XBU4
Bestmade Natural Products BM5APIS MELD3, BAPTISIAD4, CONIUM MACD8, ECHINACEAD2, EUPATORIUMD4, SILICEAD6, THUJA OCCD8Bestmade Natural Productsebdcb53e-1767-cd08-e053-2995a90aedeb2025-01-22WarningsExact identifier
unii: ETJ7Z6XBU4

Reported adverse events (FAERS/openFDA)#

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