FDA.reportPublic FDA data

NDC 69809-0127-05 - Clozaril

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
69809-0127
Requested NDC
69809-0127-05
Package NDCs from labels
69809-0127-5, 69809-0127-05
Manufacturer
HLS Therapeutics (USA), Inc.
Effective date
2025-06-06
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Clozaril - HLS Therapeutics (USA), Inc.HLS Therapeutics (USA), Inc.2025-06-06HUMAN PRESCRIPTION DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69809-0127-52020-07-22C16284748780-1ab0e2407-3629-f274-e053-dbdaa90a6471These highlights do not include all the information needed to use CLOZARIL safely and effectively. See full prescribing information for CLOZARIL. CLOZARIL ® (clozapine) tablets, for oral use Initial U.S. Approval: 1989

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69809-0127-5Clozaril100 in 1 BOTTLETABLET10021

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69809-0127CLOZARIL (CLOZAPINE) TABLET [HLS THERAPEUTICS (USA), INC.]19Current NDC, Legacy NDC, 1 package rows20250327_90876802-0e3a-44c9-9ff7-1754dfbe736a.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69809-0127-5EA - Each69809-012780065849-bd3c-45fe-81e7-b6acd1b9c5be12017-07-07

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 18 of 35 · 697 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ClozapineCLOZAPINETeva Pharmaceuticals USA, Inc.6fccf4f7-2e30-4272-9800-225aaef205842025-06-24Boxed warning, Warnings, Adverse reactionsExact identifier
unii: J60AR2IKIC
SENSITIVE POCKET SUNSENSITIVE POCKET SUNShantou Oushiya Biotechnology Co., Ltd36ac412f-e31f-6906-e063-6394a90a4a3d2025-06-14WarningsExact identifier
unii: 7SEV7J4R1U
ClozarilCLOZAPINEHLS Therapeutics (USA), Inc.90876802-0e3a-44c9-9ff7-1754dfbe736a2025-06-06Boxed warning, Warnings, Adverse reactionsExact identifier
application number: NDA019758
ndc (package): 69809-0126-5
ndc (package): 69809-0127-5
ndc (product): 69809-0126
ndc (product): 69809-0127
ndc11 (package): 69809012705
rxcui: 104776
rxcui: 197536
rxcui: 104775
rxcui: 197535
spl id: 14601465-eda2-4063-b606-cb6cfcaaca3d
spl set id: 90876802-0e3a-44c9-9ff7-1754dfbe736a
unii: J60AR2IKIC
HAIR STIMPEDICULUS 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 MINORThe Wellness Center for Research and Education, Inc.8ecc05ff-ed5a-4157-9100-1c7912686f072025-06-06WarningsExact identifier
unii: ETJ7Z6XBU4
SLIMLYCOPODIUM CLAVATUM, ABIES CANADENSIS, AMMONIUM BROMATUM, AMMONIUM MURIATICUM, PHYTOLACCA DECANDRA, PULSATILLA (PRATENSIS), AMMONIUM CARBONICUM, FUCUS VESICULOSUS, CAPSICUM ANNUUM, ARGENTUM NITRICUM, KALI BICHROMICUM, SILICEA, GLANDULA SUPRARENALIS BOVINE, CALCAREA ARSENICICA, FERRUM METALLICUM, ANTIMONIUM CRUDUM, CALCAREA CARBONICA, GRAPHITES, KALI CARBONICUM, ANACARDIUM ORIENTALE, IODIUM, THYROIDINUM (SUIS), LEPTINThe Wellness Center for Research and Education5067953f-351e-4bb0-b165-8dc62077cdea2025-06-06WarningsExact identifier
unii: ETJ7Z6XBU4
BioTox Dental Foci RepairARNICA MONTANA, HYPERICUM PERFORATUM, PLANTAGO MAJOR, ACONITUM NAPELLUS, MERCURIUS SOLUBILIS, HEKLA LAVA, ARGENTUM NITRICUM, BELLADONNA, HEPAR SULPHURIS CALCAREUM, SILICEAThe Wellness Center For Research and Education767f8dd2-759f-4662-9b5c-b8832309363d2025-06-06WarningsExact identifier
unii: ETJ7Z6XBU4
Silicea 6XSILICEA 6XTrue Botanica, LLC2cee8f0b-6d28-75e4-e063-6294a90a2e152025-06-05WarningsExact identifier
unii: ETJ7Z6XBU4
ClozapineCLOZAPINEAurobindo Pharma Limitedcaf2d4a6-2a23-4992-a807-560c4204afc42025-06-05Boxed warning, Warnings, Adverse reactionsExact identifier
unii: J60AR2IKIC
VACC HCANTIMONIUM TARTARICUM, ARSENICUM ALBUM, BRYONIA (ALBA), ECHINACEA (ANGUSTIFOLIA), GELSEMIUM SEMPERVIRENS, HEPAR SUIS, HISTAMINUM HYDROCHLORICUM, HYOSCYAMUS NIGER, INFLUENZINUM, LEDUM PALUSTRE, MERCURIUS SOLUBILIS, MEZEREUM, NICOTINAMIDUM, RNA, SENEGA OFFICINALIS, SILICEA, SPIGELIA ANTHELMIA, SULPHUR, THUJA OCCIDENTALIS, ZINCUM METALLICUMDeseret Biologicals, Inc.5e37c522-a821-4673-9220-b59c739574452025-05-27WarningsExact identifier
unii: ETJ7Z6XBU4
Sinus TonicECHINACEA (ANGUSTIFOLIA), BAPTISIA TINCTORIA, THIAMINUM HYDROCHLORICUM, HYDRASTIS CANADENSIS, PYRIDOXINUM HYDROCHLORICUM, SPONGIA TOSTA, APIS MELLIFICA, ASCORBIC ACID, HEPAR SULPHURIS CALCAREUM, KALI BICHROMICUM, LACHESIS MUTUS, MERCURIUS IODATUS RUBER, MERCURIUS SULPHURATUS RUBER, PULSATILLA (PRATENSIS), SILICEA, SINUSITISINUM, PANTOTHENIC ACIDBioActive Nutritional, Inc.63234fdc-7456-42c6-8996-fef372dd4a532025-05-20WarningsExact identifier
unii: ETJ7Z6XBU4
Inflammation IECHINACEA (ANGUSTIFOLIA), NASTURTIUM AQUATICUM, PHYTOLACCA DECANDRA, HYDRASTIS CANADENSIS, APIS MELLIFICA, BELLADONNA, FERRUM PHOSPHORICUM, NITRICUM ACIDUM, OLEANDER, SILICEABioActive Nutritional, Inc.ddfad5cd-c928-42c0-9562-9feebb73a2cb2025-05-19WarningsExact identifier
unii: ETJ7Z6XBU4
VermexARTEMISIA VULGARIS, CINA, TEUCRIUM MARUM, SPIGELIA ANTHELMIA, FILIX MAS, CALCAREA CARBONICA, GRAPHITES, MERCURIUS CORROSIVUS, SABADILLA, SILICEA, TANACETUM VULGARE, ASCARIS LUMBRICOIDES, TAENIA SOLIUMBioActive Nutritional, Inc.06b61e15-ab8b-4b7e-8378-48f87a963e442025-05-16WarningsExact identifier
unii: ETJ7Z6XBU4
Lymph IIECHINACEA (ANGUSTIFOLIA), COLLINSONIA CANADENSIS, PHYTOLACCA DECANDRA, KALI IODATUM, PINUS SYLVESTRIS, PIX LIQUIDA, FERRUM PHOSPHORICUM, AESCULUS HIPPOCASTANUM, BARYTA CARBONICA, BERBERIS VULGARIS, CALCAREA CARBONICA, CALCAREA PHOSPHORICA, CAUSTICUM, HEPAR SULPHURIS CALCAREUM, KREOSOTUM, LYCOPODIUM CLAVATUM, MERCURIUS SOLUBILIS, NATRUM MURIATICUM, NITRICUM ACIDUM, PHOSPHORUS, PULSATILLA (PRATENSIS), SILICEA, STELLARIA MEDIA, SULPHUR, TEREBINTHINA, THUJA OCCIDENTALIS, BUFO RANABioActive Nutritional, Inc.678874d0-7600-4d03-ad1e-e4dc671575972025-05-16WarningsExact identifier
unii: ETJ7Z6XBU4
Vax SodeTHUJA OCCIDENTALIS, CALCAREA CARBONICA, SILICEA, SALMONELLA TYPHI NOSODE, SERUM ANGUILLAE, BACILLUS TETANI(CLOSTRIDIUM TETANI), MALANDRINUM, MORBILLINUM, PAROTIDINUM, RUBELLA NOSODE, YERSINIA ENTEROCOLITICA, SALMONELLA ENTERIDITISNutritional Specialties, Inc.6f8cfcad-4d23-44d3-9369-22b575b1e7e62025-05-15WarningsExact identifier
unii: ETJ7Z6XBU4
ApnetemPHOSPHORICUM ACIDUM, ALUMEN, PHOSPHORUS, SENEGA OFFICINALIS, ADENOSINUM CYCLOPHOSPHORICUM, ANTIMONIUM TARTARICUM, GRINDELIA, SABADILLA, ALUMINA, CUPRUM METALLICUM, SANGUINARINUM NITRICUM, SILICEA, LACHESIS MUTUS, RHEUM (PALMATUM), ZINCUM METALLICUM, LYCOPODIUM CLAVATUM, MANGANUM PHOSPHORICUM, ANTIPYRINUM, COENZYME ANucleic Products, LLCec5bc7e7-4be6-45a6-8cd9-62fdfa7fb4692025-05-14WarningsExact identifier
unii: ETJ7Z6XBU4
DOCTRUST ONE S ToothSODIUM FLUORIDE, DENTAL TYPE SILICA, POTASSIUM NIRATEDOCSMEDI Co., Ltd.3382776a-a10e-1823-e063-6394a90a6f912025-04-24WarningsExact identifier
unii: ETJ7Z6XBU4
Bestmade Natural Products BM133 PelletsSILICEA, CARBO VEG, AURUM MUR, THUJA OCC, ACID NIT, FERRUM IODBestmade Natural Products3242a579-23f3-0063-e063-6394a90a93342025-04-08WarningsExact identifier
unii: ETJ7Z6XBU4
Bestmade Natural Products Silicea 8xSILICEABestmade Natural Products31e15fbf-2439-8d96-e063-6294a90a46ed2025-04-03WarningsExact identifier
unii: ETJ7Z6XBU4
Bestmade Natural Products BM238SANTONINE, CINA, SILICEA, INDIGO, AMBROSIA, CUCCURBITA CIT, CUCCURBITA PEPBestmade Natural Products298fb9e2-3f98-01e6-e063-6294a90a7aaf2025-03-26WarningsExact identifier
unii: ETJ7Z6XBU4
Bestmade Natural Products Silicea 6x Lactose-freeSILICEA ORGANIC CANE SUGARBestmade Natural Products2991ecbf-925e-00f3-e063-6294a90a37bf2025-03-25WarningsExact identifier
unii: ETJ7Z6XBU4

Reported adverse events (FAERS/openFDA)#

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