NDC 55513-522 - Otezla

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: 55513-522
Package NDCs from labels: 55513-522-14
Manufacturer: Amgen, Inc | Celgene International Sarl
Effective date: 2026-09-02
Current FDA listing: Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
Label	Manufacturer	Effective date	Type
Otezla - Amgen, Inc \| Celgene International Sarl	Amgen, Inc \| Celgene International Sarl	2026-09-02	HUMAN PRESCRIPTION DRUG LABEL

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 151 of 169 · 3,361 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
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: ETJ7Z6XBU4 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
MEB Puri-Mega	MEB PURI-MEGA	Kadesh Incoporation Co,Ltd	018125f2-ad4b-b38a-e063-6294a90a7f6e	2023-07-27	Warnings	Exact identifier unii: ETJ7Z6XBU4
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
VACC HC	HEPAR SUIS, HISTAMINUM HYDROCHLORICUM, THUJA OCCIDENTALIS, RNA, ECHINACEA (ANGUSTIFOLIA), LEDUM PALUSTRE, MEZEREUM, SILICEA, INFLUENZINUM (2021-2022), ANTIMONIUM TARTARICUM, ARSENICUM ALBUM, BRYONIA (ALBA), GELSEMIUM SEMPERVIRENS, HYOSCYAMUS NIGER, LAC FELINUM, MERCURIUS SOLUBILIS, NICOTINAMIDUM, SENEGA OFFICINALIS, SPIGELIA ANTHELMIA, SULPHUR, ZINCUM METALLICUM	Deseret Biologicals, Inc.	c100d87b-4d67-42ef-b7e2-fd3642a104b8	2023-07-18	Warnings	Exact identifier unii: ETJ7Z6XBU4
Sodium Chloride	SODIUM CHLORIDE	Fresenius Kabi USA, LLC	b6e33138-841a-471f-a934-c4086cbc23f6	2023-07-17	Warnings, Adverse reactions	Exact identifier unii: 451W47IQ8X
Silicea	SILICEA	Ratis, LLC	8c2b59e1-9936-486c-9a91-153e46f377e6	2023-07-13	Warnings	Exact identifier unii: ETJ7Z6XBU4
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: ETJ7Z6XBU4 unii: 451W47IQ8X
Thyrostat	FUCUS VESICULOSUS, SPONGIA TOSTA, HYPOPHYSIS SUIS, THYROIDINUM (SUIS), ARSENICUM IODATUM, BARYTA CARBONICA, IODIUM, LYCOPUS VIRGINICUS, NATRUM MURIATICUM	Energique, Inc.	5c41b36c-e28f-4d60-b9b9-6b888d55ea95	2023-07-12	Warnings	Exact identifier unii: 451W47IQ8X
Silicea	SILICON DIOXIDE	Boiron	ce6a0710-7c28-11e6-86bf-424c58303031	2023-07-11		Exact identifier unii: ETJ7Z6XBU4
Introvert Formula	PASSIFLORA INCARNATA, PULSATILLA (PRATENSIS), IGNATIA AMARA, NATRUM MURIATICUM, DUODENUM (SUIS), PETROLEUM, SULPHUR	Nutritional Specialties, Inc.	522148c9-0bc0-44c9-8876-70051224c951	2023-07-11	Warnings	Exact identifier unii: 451W47IQ8X
Hypercalm-Mental Focus	CHAMOMILLA, ECHINACEA, HYPERICUM PERFORATUM, PASSIFLORA INCARNATA, ACONITUM NAPELLUS, ADRENALINUM, ARGENTUM NIT., ARSENICUM ALBUM, BAPTISIA TINCTORIA, CHAMOMILLA, COFFEA CRUDA, CYPRIPEDIUM PUBESCENS, DIGITALIS PURPUREA, GELSEMIUM SEMPERVIRENS, HUMULUS LUPULUS, HYOSCYAMUS NIGER, IGNATIA AMARA, IMPATIENS GLANDULIFERA FLOS, IODIUM, LACHESIS MUTUS, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, NUX VOMICA, SCUTELLARIA LATERIFLORA, STAPHYSAGRIA, STRAMONIUM, THERIDION, VERATRUM VIRIDE	Newton Laboratories, Inc.	ff5f22e1-74ee-1eee-e053-6394a90a2678	2023-06-30	Warnings	Exact identifier unii: 451W47IQ8X
Hypercalm-Mental Focus	CHAMOMILLA, ECHINACEA, HYPERICUM PERFORATUM, PASSIFLORA INCARNATA, ACONITUM NAPELLUS, ADRENALINUM, ARGENTUM NIT., ARSENICUM ALBUM, BAPTISIA TINCTORIA, CHAMOMILLA, COFFEA CRUDA, CYPRIPEDIUM PUBESCENS, DIGITALIS PURPUREA, GELSEMIUM SEMPERVIRENS, HUMULUS LUPULUS, HYOSCYAMUS NIGER, IGNATIA AMARA, IMPATIENS GLANDULIFERA FLOS, IODIUM, LACHESIS MUTUS, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, NUX VOMICA, SCUTELLARIA LATERIFLORA, STAPHYSAGRIA, STRAMONIUM, THERIDION, VERATRUM VIRIDE	Newton Laboratories, Inc.	ff604442-4697-e2bb-e053-6394a90a0340	2023-06-30	Warnings	Exact identifier unii: 451W47IQ8X
Kidney Drainage	SOLIDAGO VIRGAUREA, ASPARAGUS OFFICINALIS, JUNIPERUS COMMUNIS, SABAL SERRULATA, UVA-URSI, BERBERIS VULGARIS, EQUISETUM ARVENSE, URTICA DIOICA, RUBIA TINCTORUM, STAPHYSAGRIA, CANTHARIS, FAGUS SYLVATICA, FLOS, GLANDULA SUPRARENALIS SUIS, HEPAR SULPHURIS CALCAREUM, KIDNEY (SUIS), LARIX DECIDUA, FLOS, MANGANUM METALLICUM, MIMULUS GUTTATUS, FLOS, NITRICUM ACIDUM, RHUS AROMATICA, SILICEA, ULEX EUROPAEUS, FLOS, BENZOICUM ACIDUM, COBALTUM METALLICUM	Deseret Biologicals, Inc.	4f82e261-6101-48ab-b161-ded5aa41cd85	2023-06-27	Warnings	Exact identifier unii: ETJ7Z6XBU4
Natrum muriaticum	SODIUM CHLORIDE	Boiron	86455058-2722-5c0a-e053-2a91aa0ac659	2023-06-26		Exact identifier unii: 451W47IQ8X
Hyperactivity-Mental Focus	ADRENALINUM, ACONITUM NAP., ARG. NIT., ARSENICUM ALB., BAPTISIA, CHAMOMILLA, CYPRIPEDIUM, DIGITALIS, GELSEMIUM, HUMULUS, IGNATIA, IMPATIENS GLANDULIFERA FLOS, IODIUM, LACHESIS, LYCOPODIUM, NAT. MUR., NUX VOM., SCUTELLARIA LATERIFLORA, STAPHYSAG., STRAMONIUM, THERIDION, ECHINACEA, GINGKO, HYPERICUM, PASSIFLORA	Newton Laboratories, Inc.	fecece1f-22bc-21dc-e053-6294a90ad0c3	2023-06-23	Warnings	Exact identifier unii: 451W47IQ8X
Hyperactivity-Mental Focus	ADRENALINUM, ACONITUM NAP., ARG. NIT., ARSENICUM ALB., BAPTISIA, CHAMOMILLA, CYPRIPEDIUM, DIGITALIS, GELSEMIUM, HUMULUS, IGNATIA, IMPATIENS GLANDULIFERA FLOS, IODIUM, LACHESIS, LYCOPODIUM, NAT. MUR., NUX VOM., SCUTELLARIA LATERIFLORA, STAPHYSAG., STRAMONIUM, THERIDION, ECHINACEA, GINGKO, HYPERICUM, PASSIFLORA	Newton Laboratories, Inc.	fed03a1c-0ea8-1f8e-e053-6394a90a04c0	2023-06-23	Warnings	Exact identifier unii: 451W47IQ8X

Reported adverse events (FAERS/openFDA)#

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