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
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
43386-762-01	ZOLPIDEM TARTRATE	1 in 1 BLISTER PACK	TABLET	1	6
43386-762-01	ZOLPIDEM TARTRATE	1 in 1 POUCH	TABLET	1	6
43386-762-30	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
43386-762	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
43386-762-01	EA - Each	43386-762	4be89bd4-4a1c-45bb-8486-7834ddbbe15f	1	2019-02-13
43386-762-30	EA - Each	43386-762	ccf4d3fa-09a8-4f9c-8fbe-7c77ebbcaf5b	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 29 of 54 · 1,079 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
12 CELL SALTS COMPLEX	CALCAREA FLUORICA, CALCAREA PHOSPHORICA, CALCAREA SULPHURICA, FERRUM PHOSPHORICUM, KALI MURIATICUM, KALI PHOSPHORICUM, KALI SULPHURICUM, MAGNESIA PHOSPHORICA, NATRUM MURIATICUM, NATRUM PHOSPHORICUM, NATRUM SULPHURICUM, SILICEA	SEVENE USA	ff0f69cd-97a2-7183-e053-6394a90ad039	2025-02-10	Warnings	Exact identifier unii: ETJ7Z6XBU4
SILICEA 200ck	SILICEA	SEVENE USA	cf89bb22-9e2f-9143-e053-2995a90aff19	2025-02-10	Warnings	Exact identifier unii: ETJ7Z6XBU4
Stress-Tension	CHAMOMILLA, HYPERICUM PERFORATUM, VALERIANA OFFICINALIS, ACONITUM NAPELLUS, ARGENTUM NITRICUM, AURUM METALLICUM, BAPTISIA, BRYONIA, CHELIDONIUM MAJUS, CIMICIFUGA RACEMOSA, CONIUM MACULATUM, GELSEMIUM SEMPERVIRENS, IGNATIA AMARA, KALI CARBONICUM, LACHESIS MUTUS, LILIUM TIGRINUM, LYCOPODIUM CLAVATUM, NATRUM CARBONICUM, NATRUM MURIATICUM, PHOSPHORICUM ACIDUM, PHOSPHORUS, PICRICUM ACIDUM, PLUMBUM METALLICUM, SEPIA, STAPHYSAGRIA, STRAMONIUM, THUJA OCCIDENTALIS, ZINCUM METALLICUM.	Newton Laboratories, Inc.	9d22bedb-9f9d-8421-e053-2a95a90acf4a	2025-02-10	Warnings	Exact identifier unii: 45P3261C7T
Stress-Tension	CHAMOMILLA, HYPERICUM PERFORATUM, VALERIANA OFFICINALIS, ACONITUM NAPELLUS, ARGENTUM NITRICUM, AURUM METALLICUM, BAPTISIA, BRYONIA, CHELIDONIUM MAJUS, CIMICIFUGA RACEMOSA, CONIUM MACULATUM, GELSEMIUM SEMPERVIRENS, IGNATIA AMARA, KALI CARBONICUM, LACHESIS MUTUS, LILIUM TIGRINUM, LYCOPODIUM CLAVATUM, NATRUM CARBONICUM, NATRUM MURIATICUM, PHOSPHORICUM ACIDUM, PHOSPHORUS, PICRICUM ACIDUM, PLUMBUM METALLICUM, SEPIA, STAPHYSAGRIA, STRAMONIUM, THUJA OCCIDENTALIS, ZINCUM METALLICUM.	Newton Laboratories, Inc.	9d23e5da-4806-8ccc-e053-2995a90a1901	2025-02-10	Warnings	Exact identifier unii: 45P3261C7T
Teeth-Gums	CHAMOMILLA, ECHINACEA, ACONITUM NAPELLUS, ARNICA MONTANA, ARSENICUM ALBUM, BAPTISIA TINCTORIA, BELLADONNA, BRYONIA, CALENDULA OFFICINALIS, CHAMOMILLA, CHELIDONIUM MAJUS, CROTALUS HORRIDUS, GELSEMIUM SEMPERVIRENS, HEPAR SULPHURIS CALCAREUM, KREOSOTUM, MERCURIUS VIVUS, MYRRHA, NUX VOMICA, PHOSPHORUS, PHYTOLACCA DECANDRA, PLANTAGO MAJOR, RHUS TOXICODENDRON, SILICEA, STAPHYSAGRIA	Newton Laboratories, Inc.	9d27b1e4-a966-5495-e053-2a95a90a965b	2025-02-10	Warnings	Exact identifier unii: ETJ7Z6XBU4
Teeth-Gums	CHAMOMILLA, ECHINACEA, ACONITUM NAPELLUS, ARNICA MONTANA, ARSENICUM ALBUM, BAPTISIA TINCTORIA, BELLADONNA, BRYONIA, CALENDULA OFFICINALIS, CHAMOMILLA, CHELIDONIUM MAJUS, CROTALUS HORRIDUS, GELSEMIUM SEMPERVIRENS, HEPAR SULPHURIS CALCAREUM, KREOSOTUM, MERCURIUS VIVUS, MYRRHA, NUX VOMICA, PHOSPHORUS, PHYTOLACCA DECANDRA, PLANTAGO MAJOR, RHUS TOXICODENDRON, SILICEA, STAPHYSAGRIA	Newton Laboratories, Inc.	9d363a40-a17b-2b6f-e053-2a95a90a3384	2025-02-10	Warnings	Exact identifier unii: ETJ7Z6XBU4
Dust-Mold-Dander	IRIS VERSICOLOR, SOLIDAGO VIRGAUREA, ANTIMONIUM CRUDUM, APIS MELLIFICA, ARSENICUM ALBUM, BAPTISIA TINCTORIA, BLATTA ORIENTALIS, BROMIUM, BRYONIA, CANDIDA ALBICANS, CARDUUS BENEDICTUS, CAT HAIR, CHELIDONIUM MAJUS, CINCHONA OFFICINALIS, DOG HAIR, HISTAMINUM HYDROCHLORICUM, HOUSE DUST, IPECACUANHA, LYCOPODIUM CLAVATUM, NUX VOMICA, PODOPHYLLUM PELTATUM, RHUS TOXICODENDRON, SECALE CORNUTUM, SILICEA, USTILAGO MAIDIS, TORULA CEREVISIAE.	Newton Laboratories, Inc.	99fdc906-3a55-e4c4-e053-2a95a90a76ba	2025-02-10	Warnings	Exact identifier unii: ETJ7Z6XBU4
ZOLPIDEM TARTRATE	ZOLPIDEM TARTRATE	Asclemed USA, Inc.	e5e2d31b-ce26-78b0-e053-2a95a90ac491	2025-02-09	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: WY6W63843K
Bestmade Natural Products BM118	ANACARDIUM ORI, ARSENIC ALB, AURUM MUR, KALI BROM, LYCOPODIUM, NATRUM CARB, NATRUM SULPH, PHOSPHORIC ACID	Bestmade Natural Products	2d90b08b-b65d-7d11-e063-6294a90a5092	2025-02-07	Warnings	Exact identifier unii: 45P3261C7T
Leg Cramps-Swelling	ECHINACEA, ARGENTUM NITRICUM, BRYONIA, CALCAREA CARBONICA, COLOCYNTHIS, CONVALLARIA MAJALIS, CROTALUS HORRIDUS, CUPRUM METALLICUM, DIGITALIS , GELSEMIUM SEMPERVIRENS, HYPERICUM PERFORATUM, KALI CARBONICUM, LACHESIS MUTUS, LATHYRUS SATIVUS, LILIUM TIGRINUM, MAGNESIA PHOSPHORICA, NUX VOMICA, RHUS TOXICODENDRON, SILICEA, STRAMONIUM, VERATRUM VIRIDE, ELAPS	Newton Laboratories, Inc.	9c315126-e61e-f649-e053-2a95a90a7f08	2025-02-07	Warnings	Exact identifier unii: ETJ7Z6XBU4
Lymphatic Care	ECHINACEA, SOLIDAGO, TARAXACUM, ASTERIAS, AUR. MET., BELLADONNA, BENZOICUM AC., BERBER. VULG., BRYONIA, CALC. CARB., CANTHARIS, CARDUUS MAR., CEANOTHUS, CHELIDONIUM MAJ., CHIONANTHUS, CINCHONA, DIOSCOREA, IRIS VERS., NAT. CARB., NUX VOM., PTELEA..	Newton Laboratories, Inc.	9c3507de-1def-4019-e053-2a95a90a1475	2025-02-07	Warnings	Exact identifier unii: 45P3261C7T
Lymphatic Care	ECHINACEA, SOLIDAGO, TARAXACUM, ASTERIAS, AUR. MET., BELLADONNA, BENZOICUM AC., BERBER. VULG., BRYONIA, CALC. CARB., CANTHARIS, CARDUUS MAR., CEANOTHUS, CHELIDONIUM MAJ., CHIONANTHUS, CINCHONA, DIOSCOREA, IRIS VERS., NAT. CARB., NUX VOM., PTELEA..	Newton Laboratories, Inc.	9c36201a-2153-0600-e053-2995a90a6bbf	2025-02-07	Warnings	Exact identifier unii: 45P3261C7T
Ambien	ZOLPIDEM TARTRATE	Cosette Pharmaceuticals, Inc.	747949c5-2c91-4909-8a07-71b6826f8e97	2025-02-07	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: WY6W63843K
Ambien CR	ZOLPIDEM TARTRATE	Cosette Pharmaceuticals, Inc.	2d934da3-bd77-4470-e063-6294a90a64f5	2025-02-07	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: WY6W63843K
Appetite - Craving Control	ANACARDIUM ORIENTALE, ANTIMON.CRUD., ARG. NIT., BERBER. VULG., BRYONIA, CHELIDONIUM MAJUS, DIGITALIS, GRAPHITES, HUMULUS,IRIS VERSICOLOR, KALI CARB., LYCOPODIUM, NAT. CARB.,NAT. SULPHURICUM, NUX VOM., PULSATILLA, RHUS. TOXICODENDRON, SCUTELLARIA LATERIFLORA, SEPIA,STRAMONIUM, CHAMOMILLA, PASSIFLORA, VALERIANA.	Newton Laboratories, Inc.	7964f0f7-7774-fac6-e053-2a91aa0a3e4a	2025-02-06	Warnings	Exact identifier unii: 45P3261C7T
Tummy Upset	CHAMOMILLA, 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.	9dc307a2-4aa1-b02a-e053-2995a90a1788	2025-02-06	Warnings	Exact identifier unii: 45P3261C7T
Appetite - Craving Control	ANACARDIUM ORIENTALE, ANTIMON.CRUD., ARG. NIT., BERBER. VULG., BRYONIA, CHELIDONIUM MAJUS, DIGITALIS, GRAPHITES, HUMULUS,IRIS VERSICOLOR, KALI CARB., LYCOPODIUM, NAT. CARB.,NAT. SULPHURICUM, NUX VOM., PULSATILLA, RHUS. TOXICODENDRON, SCUTELLARIA LATERIFLORA, SEPIA,STRAMONIUM, CHAMOMILLA, PASSIFLORA, VALERIANA.	Newton Laboratories, Inc.	79655acc-f059-e509-e053-2a91aa0ac488	2025-02-06	Warnings	Exact identifier unii: 45P3261C7T
Dust-Mold-Dander	IRIS VERSICOLOR, SOLIDAGO VIRGAUREA, ANTIMONIUM CRUDUM, APIS MELLIFICA, ARSENICUM ALBUM, BAPTISIA TINCTORIA, BLATTA ORIENTALIS, BROMIUM, BRYONIA, CANDIDA ALBICANS, CARDUUS BENEDICTUS, CAT HAIR, CHELIDONIUM MAJUS, CINCHONA OFFICINALIS, DOG HAIR, HISTAMINUM HYDROCHLORICUM, HOUSE DUST, IPECACUANHA, LYCOPODIUM CLAVATUM, NUX VOMICA, PODOPHYLLUM PELTATUM, RHUS TOXICODENDRON, SECALE CORNUTUM, SILICEA, USTILAGO MAIDIS, TORULA CEREVISIAE.	Newton Laboratories, Inc.	9bb84bae-9019-ed76-e053-2a95a90a5c3e	2025-02-06	Warnings	Exact identifier unii: ETJ7Z6XBU4
Dust-Mold-Dander	IRIS VERSICOLOR, SOLIDAGO VIRGAUREA, ANTIMONIUM CRUDUM, APIS MELLIFICA, ARSENICUM ALBUM, BAPTISIA TINCTORIA, BLATTA ORIENTALIS, BROMIUM, BRYONIA, CANDIDA ALBICANS, CARDUUS BENEDICTUS, CAT HAIR, CHELIDONIUM MAJUS, CINCHONA OFFICINALIS, DOG HAIR, HISTAMINUM HYDROCHLORICUM, HOUSE DUST, IPECACUANHA, LYCOPODIUM CLAVATUM, NUX VOMICA, PODOPHYLLUM PELTATUM, RHUS TOXICODENDRON, SECALE CORNUTUM, SILICEA, USTILAGO MAIDIS, TORULA CEREVISIAE.	Newton Laboratories, Inc.	9ba993f4-97af-4119-e053-2995a90a126d	2025-02-06	Warnings	Exact identifier unii: ETJ7Z6XBU4
Ear Wax Build-Up	ELAPS CORALLINUS, ALUMINA, CARBO VEG., CAUSTICUM, CONIUM, GRAPHITES, KALI BIC.,KALI MUR., LACHESIS, LYCOPODIUM, PETROLEUM, PULSATILLA, SABADILLA, SEPIA, SILICEA, SPONGIA, VERBASCUM, VIOLA ODORATA	Newton Laboratories, Inc.	9302b838-6003-ba6a-e053-2995a90aedd3	2025-02-06	Warnings	Exact identifier unii: ETJ7Z6XBU4

Reported adverse events (FAERS/openFDA)#

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