NDC 65757-304 - VIVITROL

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: 65757-304
Package NDCs from labels: 65757-304-03
Manufacturer: Alkermes, Inc. | Packaging Coordinators, LLC | Sharp Corporation
Effective date: 2026-05-31
Current FDA listing: Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
Label	Manufacturer	Effective date	Type
VIVITROL - Alkermes, Inc. \| Packaging Coordinators, LLC \| Sharp Corporation	Alkermes, Inc. \| Packaging Coordinators, LLC \| Sharp Corporation	2026-05-31	HUMAN PRESCRIPTION DRUG LABEL

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
65757-304	VIVITROL (NALTREXONE) KIT [ALKERMES, INC.]	36	Unmatched	20240608_cd11c435-b0f0-4bb9-ae78-60f101f3703f.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version	Uploaded
naltrexone	ACTIVE INGREDIENT	5S6W795CQM	VIVITROL (NALTREXONE) KIT [ALKERMES, INC.]	14
naltrexone	ACTIVE MOIETY	5S6W795CQM	VIVITROL (NALTREXONE) KIT [ALKERMES, INC.]	14

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 46 of 57 · 1,133 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Anubis Barcelona	PROPANEDIOL, GLYCERIN, MAGNESIUM ASCORBYL PHOSPHATE	ANUBIS COSMETICS SL	eb53cba1-0509-43bc-e053-2995a90a5e09	2023-09-01	Warnings	Exact identifier unii: 059QF0KO0R
Anubis Barcelona Spa Line	ORYZA SATIVA (RICE) STARCH, PERLITE, PALMITIC ACID	ANUBIS COSMETICS SL	eb01a962-ab38-18ec-e053-2995a90acdeb	2023-09-01	Warnings	Exact identifier unii: 059QF0KO0R
Anubis Barcelona	FERULIC ACID, VITAMIN C, DMAE	ANUBIS COSMETICS SL	eaf0770c-795d-0232-e053-2a95a90ae0b5	2023-09-01	Warnings	Exact identifier unii: 059QF0KO0R
Anubis Barcelona Regul OIl	PEG-40 HYDROGENATED CASTOR OIL, PROPYLENE GLYCOL, ARCTIUM MAJUS ROOT EXTRACT	ANUBIS COSMETICS SL	eb905bd0-c600-b8b2-e053-2995a90ad259	2023-09-01	Warnings	Exact identifier unii: 059QF0KO0R
Anubis Barcelona Regul Oil	PROPYLENE GLYCOL, GLYCERYL STEARATE SE, HUMULUS LUPULUS (HOPS) CONE EXTRACT	ANUBIS COSMETICS SL	eb7c418b-8bee-26a3-e053-2a95a90a4e96	2023-09-01	Warnings	Exact identifier unii: 059QF0KO0R
Anubis Barcelona Total Hydrating	BETAINE, GLYCERIN, POLYSORBATE 20	ANUBIS COSMETICS SL	eaefe3b9-9064-18b1-e053-2a95a90a5765	2023-09-01	Warnings	Exact identifier unii: 059QF0KO0R unii: 7T1F30V5YH
Anubis Barcelona New Even	LACTIC ACID, CITRIC ACID, GLYCOLIC ACID	ANUBIS COSMETICS SL	eaeeb6e0-5322-20c4-e053-2995a90a9fd9	2023-09-01	Warnings	Exact identifier unii: 059QF0KO0R
Ringers	SODIUM CHLORIDE, POTASSIUM CHLORIDE, AND CALCIUM CHLORIDE	B. Braun Medical Inc.	b53c598c-dc7d-4a15-9319-8edf265e7b42	2023-08-30	Warnings, Adverse reactions	Exact identifier unii: 451W47IQ8X
Anubis Barcelona Vital Line	HYDROLYZED COLLAGEN	ANUBIS COSMETICS SL	f564bbf0-3b5c-4a81-e053-2a95a90a7ea6	2023-08-29	Warnings	Exact identifier unii: 059QF0KO0R
BABY MUCUS PLUS COLD RELIEF	BRYONIA ALBA ROOT, EUPHRASIA STRICTA, CALCIUM SULFIDE, SODIUM CHLORIDE, PHOSPHORUS, ANEMONE PULSATILLA, RUMEX CRISPUS ROOT, AND SILICON DIOXIDE	Hyland's Inc.	d934cc8a-1e43-4942-858a-05b5d068679a	2023-08-22	Warnings	Exact identifier unii: 451W47IQ8X
Hepaticol Sarcode	CARDUUS MARIANUS, ZINGIBER OFFICINALE, BERBERIS VULGARIS, CHELIDONIUM MAJUS, MAGNESIA MURIATICA, LEPTANDRA VIRGINICA, NATRUM MURIATICUM, BRYONIA (ALBA), HEPAR (BOVINE), NATRUM SULPHURICUM, ATROPINUM SULPHURICUM, LYCOPODIUM CLAVATUM	Nutritional Specialties, Inc.	f9d95b2f-53d9-4017-873f-5ad0b129f9f8	2023-08-14	Warnings	Exact identifier unii: 451W47IQ8X
Cellergy	CALCAREA FLUORICA, CALCAREA PHOSPHORICA, CALCAREA SULPHURICA, FERRUM PHOSPHORICUM, KALI MURIATICUM, KALI PHOSPHORICUM, KALI SULPHURICUM, MAGNESIA PHOSPHORICA, NATRUM MURIATICUM, NATRUM PHOSPHORICUM, NATRUM SULPHURICUM, SILICEA.	Ratis, LLC	2aebc11e-eeb7-436b-b90c-3a2f59fb7492	2023-08-07	Warnings	Exact identifier unii: 451W47IQ8X
Allergies	APIS MELLIFICA, ECHINACEA, HYDRASTIS CANADENSIS, TARAXACUM OFFICINALE, ACONITUM NAPELLUS, AETHUSA CYNAPIUM, AGARICUS MUSCARIUS, ALETRIS FARINOSA, ALFALFA, ALLIUM CEPA, ALLIUM SATIVUM, AMBROSIA ARTEMISIAEFOLIA, ARSENICUM ALBUM, ARTEMISIA VULGARIS, ARUNDO MAURITANICA, AVENA SATIVA, BELLADONNA, BELLIS PERRENIS, BOVISTA, BROMIUM, BRYONIA, CAFFEINUM, CALCAREA CARBONICA, CALLUNA VULGARIS, FLOS, CAPSICUM ANNUUM, CAT HAIR, CHAMOMILLA, CHELIDONIUM MAJUS, CHENOPODIUM ANTHELMINTICUM, CINNAMOMUM	Newton Laboratories, Inc.	017f3bcf-0e45-d390-e063-6394a90a588e	2023-07-28	Warnings	Exact identifier unii: 451W47IQ8X
Allergies	APIS MELLIFICA, ECHINACEA, HYDRASTIS CANADENSIS, TARAXACUM OFFICINALE, ACONITUM NAPELLUS, AETHUSA CYNAPIUM, AGARICUS MUSCARIUS, ALETRIS FARINOSA, ALFALFA, ALLIUM CEPA, ALLIUM SATIVUM, AMBROSIA ARTEMISIAEFOLIA, ARSENICUM ALBUM, ARTEMISIA VULGARIS, ARUNDO MAURITANICA, AVENA SATIVA, BELLADONNA, BELLIS PERRENIS, BOVISTA, BROMIUM, BRYONIA, CAFFEINUM, CALCAREA CARBONICA, CALLUNA VULGARIS, FLOS, CAPSICUM ANNUUM, CAT HAIR, CHAMOMILLA, CHELIDONIUM MAJUS, CHENOPODIUM ANTHELMINTICUM, CINNAMOMUM	Newton Laboratories, Inc.	017f0210-195d-11d7-e063-6294a90aa750	2023-07-27	Warnings	Exact identifier unii: 451W47IQ8X
Melatonin Pro	CALCAREA CARBONICA, CHAMOMILLA, COCCULUS INDICUS, COFFEA CRUDA, FERRUM PHOSPHORICUM, KALI PHOSPHORICUM, MAGNESIA CARBONICA, MELATONIN, NATRUM MURIATICUM, NUX VOMICA, PULSATILLA (PRATENSIS)	Energique, Inc.	1f374642-83f7-4e64-b330-0f6ef21000a9	2023-07-19	Warnings	Exact identifier unii: 451W47IQ8X
Gum Therapy	CALENDULA OFFICINALIS, KALI PHOSPHORICUM, NATRUM MURIATICUM, ARNICA MONTANA, AGAVE AMERICANA, CISTUS CANADENSIS, KREOSOTUM, MYRRHA, CALCAREA FLUORICA, ACONITUM NAPELLUS, BISMUTHUM SUBNITRICUM, SEPIA, HEPAR SULPHURIS CALCAREUM, MERCURIUS VIVUS	Deseret Biologicals	0cf8a815-808d-4018-baf9-2b4545fc7ea8	2023-07-19	Warnings	Exact identifier unii: 451W47IQ8X
REFL HS	ADENOSINUM TRIPHOSPHORICUM DINATRUM, NADIDUM, ARGENTUM NITRICUM, IPECACUANHA, ROBINIA PSEUDOACACIA, SULPHUR, ORIGANUM VULGARE, DUODENUM (SUIS), ESOPHAGUS (SUIS), FUNICULUS UMBILICALIS SUIS, STOMACH (SUIS), NUX VOMICA, COUMARINUM, ERYTHRAEA CENTAURIUM, PANCREATINUM, MURIATICUM ACIDUM, CITRICUM ACIDUM, FORMICUM ACIDUM, SARCOLACTICUM ACIDUM, COENZYME A, PROTEUS (MORGANI)	Deseret Biologicals, Inc.	2fe2d3c1-1829-4a33-be8e-2bad52546f36	2023-07-17	Warnings	Exact identifier unii: QTT17582CB
Sodium Chloride	SODIUM CHLORIDE	Fresenius Kabi USA, LLC	b6e33138-841a-471f-a934-c4086cbc23f6	2023-07-17	Warnings, Adverse reactions	Exact identifier unii: 451W47IQ8X
Anpituapar	HYPOPHYSIS SUIS, AGNUS CASTUS, BARYTA CARBONICA, CALCAREA CARBONICA, IODIUM, NATRUM MURIATICUM, PHOSPHORICUM ACIDUM, SEPIA, THYROIDINUM (SUIS), LAC CANINUM, ADRENOCORTICOTROPHIN	Energique, Inc.	c0ed2996-8eb5-43f7-b3cc-17477af7f7e9	2023-07-13	Warnings	Exact identifier unii: 451W47IQ8X
Pneumotox	TRITICUM AESTIVUM, ALFALFA, ARNICA MONTANA, ASCLEPIAS TUBEROSA, CHAMOMILLA, ECHINACEA (ANGUSTIFOLIA), EUCALYPTUS GLOBULUS, FUCUS VESICULOSUS, HORDEUM VULGARE, IODIUM, NASTURTIUM AQUATICUM, PLANTAGO MAJOR, RAPHANUS SATIVUS, TRIFOLIUM PRATENSE, TRIGONELLA FOENUM-GRAECUM, SYMPHYTUM OFFICINALE, LUNG (SUIS), ORYZA SATIVA, SILICEA, ACETONE, SODIUM TRIPOLYPHOSPHATE, PROPYLENE GLYCOL, BENZINUM, AMMONIUM MURIATICUM, SODIUM LAURYL SULFATE, TEREBINTHINA, ARSENICUM ALBUM, NATRUM MURIATICUM, NITRICUM ACIDUM,	BioActive Nutritional, Inc.	f8846fb1-92e5-4f8e-b3b3-bc620df90a62	2023-07-12	Warnings	Exact identifier unii: 451W47IQ8X

Reported adverse events (FAERS/openFDA)#

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