NDC 43386-761-01 - 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: 43386-761
Requested NDC: 43386-761-01
Package NDCs from labels: 43386-761-01, 43386-761-30
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
Label	Manufacturer	Effective date	Type
ZOLPIDEM TARTRATE - Lupin Pharmaceuticals,Inc. \| Novel Laboratories, Inc.	Lupin Pharmaceuticals,Inc. \| Novel Laboratories, Inc.	2020-11-18	HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
43386-761-01	ZOLPIDEM TARTRATE	1 in 1 BLISTER PACK	TABLET	1	6
43386-761-01	ZOLPIDEM TARTRATE	1 in 1 POUCH	TABLET	1	6
43386-761-30	ZOLPIDEM TARTRATE	30 in 1 CARTON	TABLET	30	6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
43386-761	ZOLPIDEM TARTRATE TABLET [LUPIN PHARMACEUTICALS,INC.]	6	Current NDC, Legacy NDC, 3 package rows	20201119_6db679f6-b1f8-4fbf-9e87-9cef4650c45a.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
43386-761-01	EA - Each	43386-761	97913eb7-4aa3-498c-a0b9-c8b63b3edd45	1	2019-02-13
43386-761-30	EA - Each	43386-761	f4c0a155-2732-48da-b471-6ddf5ea9840a	1	2016-04-04

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 48 of 53 · 1,047 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ear Care	ECHINACEA, HYDRASTIS CANADENSIS, APIS MELLIFICA, ARSENICUM ALBUM, BELLADONNA, BRYONIA, CAPSICUM ANNUUM, CAUSTICUM, CINCHONA OFFICINALIS, CONIUM MACULATUM, DULCAMARA, FERRUM PHOSPHORICUM, HEPAR SULPHURIS CALCAREUM, KALI SULPHURICUM, LYCOPODIUM CLAVATUM, MERCURIUS VIVUS, MEZEREUM, PHOSPHORUS, PLANTAGO MAJOR, PULSATILLA, SILICEA, VERBASCUM THAPSUS, TELLURIUM METALLICUM, INFLUENZINUM	Newton Laboratories, Inc.	da807eb3-34a3-61b9-e053-2995a90a0e21	2022-03-18	Warnings	Exact identifier unii: ETJ7Z6XBU4
Ear Care	INFLUENZINUM, TELLURIUM METALLICUM, APIS MEL., ARSENICUM ALB., BELLADONNA, BRYONIA, CAPSICUM, CAUSTICUM, CINCHONA, CONIUM, DULCAMARA, FERRUM PHOSPHORICUM, HEPAR SULPH. CALC.,KALI SULPH., LYCOPODIUM, MERC. VIV., MEZEREUM, PHOSPHORUS, PLANTAGO, PULSATILLA, SILICEA, VERBASCUM, ECHINACEA, HYDRASTIS	Newton Laboratories, Inc.	da80a5ea-f603-719e-e053-2995a90a9710	2022-03-18	Warnings	Exact identifier unii: ETJ7Z6XBU4
Ear Care	INFLUENZINUM, TELLURIUM METALLICUM, APIS MEL., ARSENICUM ALB., BELLADONNA, BRYONIA, CAPSICUM, CAUSTICUM, CINCHONA, CONIUM, DULCAMARA, FERRUM PHOSPHORICUM, HEPAR SULPH. CALC.,KALI SULPH., LYCOPODIUM, MERC. VIV., MEZEREUM, PHOSPHORUS, PLANTAGO, PULSATILLA, SILICEA, VERBASCUM, ECHINACEA, HYDRASTIS	Newton Laboratories, Inc.	da81b21a-090a-dabf-e053-2995a90aa05e	2022-03-18	Warnings	Exact identifier unii: ETJ7Z6XBU4
Ear Care	INFLUENZINUM, TELLURIUM METALLICUM, APIS MEL., ARSENICUM ALB., BELLADONNA, BRYONIA, CAPSICUM, CAUSTICUM, CINCHONA, CONIUM, DULCAMARA, FERRUM PHOSPHORICUM, HEPAR SULPH. CALC.,KALI SULPH., LYCOPODIUM, MERC. VIV., MEZEREUM, PHOSPHORUS, PLANTAGO, PULSATILLA, SILICEA, VERBASCUM, ECHINACEA, HYDRASTIS	Newton Laboratories, Inc.	da821d05-b2f0-3582-e053-2a95a90afe59	2022-03-18	Warnings	Exact identifier unii: ETJ7Z6XBU4
Ear Care	ECHINACEA, HYDRASTIS CANADENSIS, APIS MELLIFICA, ARSENICUM ALBUM, BELLADONNA, BRYONIA, CAPSICUM ANNUUM, CAUSTICUM, CINCHONA OFFICINALIS, CONIUM MACULATUM, DULCAMARA, FERRUM PHOSPHORICUM, HEPAR SULPHURIS CALCAREUM, KALI SULPHURICUM, LYCOPODIUM CLAVATUM, MERCURIUS VIVUS, MEZEREUM, PHOSPHORUS, PLANTAGO MAJOR, PULSATILLA, SILICEA, VERBASCUM THAPSUS, TELLURIUM METALLICUM, INFLUENZINUM	Newton Laboratories, Inc.	da717cf0-54af-c4e2-e053-2995a90ac97c	2022-03-17	Warnings	Exact identifier unii: ETJ7Z6XBU4
ACNE HP	CARBO ANIMALIS, ACTIVATED CHARCOAL, POTASSIUM DICHROMATE, SODIUM CHLORIDE, PULSATILLA VULGARIS, SEPIA OFFICINALIS JUICE, SILICON DIOXIDE, SULFUR, ZINC	Natural Creations, Inc.	b2368ab6-e233-4473-99fa-86e1fbc2a879	2022-02-14	Warnings	Exact identifier unii: ETJ7Z6XBU4
Headek Nasal	BELLADONNA, GLONOINUM, COFFEA, NATRUM CARB, NATRUM MUR.	Be Well Medical dba Richard Clement Nutrition y Be Well Homeopathics	976b9c85-68c9-46a5-9012-53cb24683b03	2021-12-29	Warnings	Exact identifier unii: 45P3261C7T
EAR RX	ACONITUM NAP, BARYTA CARB, BELLADONNA, CALC CARB, CAPSICUM, CARBO VEG, CAUSTICUM, CHAMOMILLA, FERRUM PHOS, HEPAR SULPH CALC, KALI MUR, LACHESIS, LYCOPODIUM, MERCURIUS SOL, NATRUM MUR, PLANTAGO, PULSATILLA, SILICEA, SULPHUR, VERBASCUM	Miami Beach Pediatrics pa	a8753f88-4b8a-472f-a4bd-f2e9cec83610	2021-12-29	Warnings	Exact identifier unii: ETJ7Z6XBU4
Joette Calabrese Survivalist Kit	ABROT ACON AGN AIL AMBR AMBRO AM-C ANT-C APIS ARN ARS AUR-A AUR BAPT BAR-C BELL BB BOTH BOV BROM CADM-S CALAD CALC CAMPH CARB-AC CARD-M CEAN CHEL CHININ-A CINA CHIN CIC COB COLCH CON CROT-H CROT-T CUPR DULC ELAPS EUP-PER FL-AC GALPH GRAPH GUNP HAM HEKLA HELL HEP HYDR-AC HYOS HYPER KALI-BR KALI-C KALI-I LATH LAUR LED LOB MERC-CY MERC MEZ MOSCH MUR-AC NAJA NAT-C NIT-AC NUX-M PYROG PH-AC PIC-AC PLB RHUS-T RUTA SAMB SANG SARR SEP STRAM SUL-AC TAB TERENT TER TEUCR VERAT VERAT-V VIP	OHM PHARMA INC.	1ac2a2c4-704e-4efa-aa44-acc71d300f70	2021-12-29	Warnings	Exact identifier unii: 45P3261C7T
Lyme Disease Support 2	ARGENTUM NITRICUM, ASTRAGALUS MENZIESII, CALCAREA SULPHURICA, CUPRUM ARSENICOSUM, DNA, FERRUM PHOSPHORICUM, KALI MURIATICUM, KALI SULPHURICUM, LEDUM PALUSTRE, MAGNESIA PHOSPHORICA, RNA, SILICEA.	OHM PHARMA INC.	13b4b78b-f9f7-4cf6-8f43-61679160086b	2021-12-29	Warnings	Exact identifier unii: ETJ7Z6XBU4
Lyme Disease Support 1	ALUMEN, CALCAREA CARBONICA, DNA, FERRUM PHOSPHORICUM, HEPAR SULPHURIS CALCAREUM, KALI CARBONICUM, KALI MURIATICUM, KALI SULPHURICUM, MAGNESIA PHOSPHORICA, NATRUM MURIATICUM, NATRUM PHOSPHORICUM, RNA, SILICEA.	OHM PHARMA INC.	035e75d6-aeef-4dfd-b076-9d3d8e4a5086	2021-12-29	Warnings	Exact identifier unii: ETJ7Z6XBU4
OHM Skin Healing Cream	CALENDULA OFFICINALIS, STELLARIA MEDIA, CALCAREA SULPHURICA, CHAMOMILLA, ECHINACEA ANGUSTIFOLIA, SILICEA, SYMPHYTUM OFFICINALE, THIOSINAMIUM, HAMAMELIS VIRGINIANA.	OHM PHARMA INC.	c12e6706-37f0-4900-856c-fc7e7ac3b724	2021-12-29	Warnings	Exact identifier unii: ETJ7Z6XBU4
OHM Skin Healing Gel	CALENDULA OFFICINALIS, STELLARIA MEDIA, CALCAREA SULPHURICA, CHAMOMILLA, ECHINACEA ANGUSTFOLIA, SILICEA, SYMPHYTUM OFFICINALE, THIOSINAMIUM, HAMAMELIS VIRGINIANA.	OHM PHARMA INC.	f97dffe6-cddc-4577-afcc-deadb7abd0c6	2021-12-29	Warnings	Exact identifier unii: ETJ7Z6XBU4
Sodium Bicarbonate	SODIUM BICARBONATE	International Medication Systems, Limited	77698221-a01d-4568-a7bc-d3d4e982875d	2021-12-15	Warnings, Adverse reactions	Exact identifier unii: 8MDF5V39QO
ReHydration	ADENOSINUM CYCLOPHOSPHORICUM, COFFEA CRUDA, GLANDULA SUPRARENALIS SUIS, HYPOTHALAMUS, KALI PHOS, NAT MUR, SARSAPARILLA, SILICEA, TARAXACUM, THYROIDINUM	Energetix	75826e2a-737a-43ac-aed7-fad960889b88	2021-12-15	Warnings	Exact identifier unii: ETJ7Z6XBU4
HAIR STIM	PEDICULUS CAPITIS, THYROIDINUM (SUIS), BARYTA CARBONICA, BORAX, CALCAREA CARBONICA, CINCHONA OFFICINALIS, GLANDULA SUPRARENALIS SUIS, HYDROFLUORICUM ACIDUM, MERCURIUS SOLUBILIS, MEZEREUM, NATRUM MURIATICUM, PHOSPHORUS, PULSATILLA (PRATENSIS), SEPIA, SILICEA, SULPHUR, THUJA OCCIDENTALIS, VINCA MINOR	The Wellness Center for Research and Education, Inc.	d5c75dc2-9edc-429e-8f25-e5641fe5042f	2021-11-23	Warnings	Exact identifier unii: ETJ7Z6XBU4
CONSTIPATION CP	ALUMINUM OXIDE, BRYONIA ALBA ROOT, MATRICARIA RECUTITA, GRAPHITE, LYCOPODIUM CLAVATUM SPORE, STRYCHNOS NUX-VOMICA SEED, SILICON DIOXIDE, SULFUR, SODIUM CHLORIDE, MAGNESIUM CHLORIDE, LEAD, SEPIA OFFICINALIS JUICE.	Natural Creations, Inc.	961b3ddf-41fe-46ed-b5e4-0fd8d9652edf	2021-11-15	Warnings	Exact identifier unii: ETJ7Z6XBU4
CENTROCODE	AMERICAN GINSENG, ADENOSINE TRIPHOSPHATE, CORTICOTROPIN, ALFALFA, BOS TAURUS HYPOTHALAMUS, PHYTOLACCA AMERICANA ROOT, BOS TAURUS PITUITARY GLAND POSTERIOR, THYROID UNSPECIFIED, IODINE, SILICON DIOXIDE, OSTER SHELL CALCIUM CARBONATE CRUDE, STRYCHNOS IGNATII SEED, IRIDIUM, LACHESIS MUTA VENOM, LYCOPODIUM CLAVATUM SPORE, SODIUM CHLORIDE, STRYCHNOS NUX-VOMICA SEED, PHOSPHORUS, SELENIUM, URANYL NITRATE HEXAHYDRATE.	Natural Creations, Inc.	e5bbe9ec-7602-4de5-907a-7047c10198b6	2021-11-15	Warnings	Exact identifier unii: ETJ7Z6XBU4
Hydrate 2	BERBERISAQUIFOLIUM,BETAVULGARIS,BOLDO,CHELIDONIUMMAJUS,HORDEUMVULGARE,IRISVERSICOLOR,ROSMARINUSOFFICINALIS,CARDUUSMARIANUS,TARAXACUMOFFICINALE,AVENASATIVA,ELEUTHEROCOCCUSSENTICOSUS,XANTHOXYLUMFRAXINEUM,EQUISETUMHYEMALE,HYPERICUMPERFORATUM,ULMUSFULVA,GETTYSBURGAQUA,GLYCYRRHIZAGLABRA,WILDBADAQUA,CARLSBADAQUA,ATP,HYDROGEN,NATRUMMURIATICUM,OXYGEN,SILICEA,WIESBADENAQUA	Natural Creations, Inc	52cb98dc-6858-42bf-9c54-d20fb607dfbb	2021-11-12	Warnings	Exact identifier unii: ETJ7Z6XBU4
SILICEA	SILICEA	Rxhomeo Private Limited d.b.a. Rxhomeo, Inc	0000025c-6dbf-4af7-a741-5cbacaed519a	2021-09-02	Warnings	Exact identifier unii: ETJ7Z6XBU4

Reported adverse events (FAERS/openFDA)#

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