FDA.reportPublic FDA data

NDC 0093-3012-19 - Clozapine

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
0093-3012
Requested NDC
0093-3012-19
Package NDCs from labels
0093-3012-01, 0093-3012-19, 0093-3012-84
Manufacturer
Teva Pharmaceuticals USA Inc | Jazz Pharmaceuticals, Inc.
Effective date
2022-03-03
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Clozapine - Teva Pharmaceuticals USA Inc | Jazz Pharmaceuticals, Inc.Teva Pharmaceuticals USA Inc | Jazz Pharmaceuticals, Inc.2022-03-03HUMAN PRESCRIPTION DRUG LABEL
National Council for Prescription Drug Programs indexing - billing unitNational Council for Prescription Drug Programs2013-02-13Indexing - Billing Unit

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0093-3012-01EA - Each0093-3012865dcca1-5d00-4ec0-934e-44f595cd357b12013-02-13
0093-3012-19EA - Each0093-301272df6856-d386-4312-a7e3-fa41d17d14dc12013-02-13
0093-3012-84EA - Each0093-3012cac93bdf-21f9-4c7e-ae02-1c0e485d1b9412013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CLOZAPINEACTIVE INGREDIENTJ60AR2IKICCLOZAPINE TABLET, ORALLY DISINTEGRATING [TEVA PHARMACEUTICALS USA INC]11
CLOZAPINEACTIVE MOIETYJ60AR2IKICCLOZAPINE TABLET, ORALLY DISINTEGRATING [TEVA PHARMACEUTICALS USA INC]11
ASPARTAMEINACTIVE INGREDIENTZ0H242BBR1CLOZAPINE TABLET, ORALLY DISINTEGRATING [TEVA PHARMACEUTICALS USA INC]11
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCLOZAPINE TABLET, ORALLY DISINTEGRATING [TEVA PHARMACEUTICALS USA INC]11
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPCLOZAPINE TABLET, ORALLY DISINTEGRATING [TEVA PHARMACEUTICALS USA INC]11
CROSPOVIDONEINACTIVE INGREDIENT68401960MKCLOZAPINE TABLET, ORALLY DISINTEGRATING [TEVA PHARMACEUTICALS USA INC]11
DIMETHYLAMINOETHYL METHACRYLATE - BUTYL METHACRYLATE - METHYL METHACRYLATE COPOLYMERINACTIVE INGREDIENT905HNO1SIHCLOZAPINE TABLET, ORALLY DISINTEGRATING [TEVA PHARMACEUTICALS USA INC]11
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTCLOZAPINE TABLET, ORALLY DISINTEGRATING [TEVA PHARMACEUTICALS USA INC]11
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CLOZAPINE TABLET, ORALLY DISINTEGRATING [TEVA PHARMACEUTICALS USA INC]11
MANNITOLINACTIVE INGREDIENT3OWL53L36ACLOZAPINE TABLET, ORALLY DISINTEGRATING [TEVA PHARMACEUTICALS USA INC]11
MINTINACTIVE INGREDIENTFV98Z8GITPCLOZAPINE TABLET, ORALLY DISINTEGRATING [TEVA PHARMACEUTICALS USA INC]11
SODIUM BICARBONATEINACTIVE INGREDIENT8MDF5V39QOCLOZAPINE TABLET, ORALLY DISINTEGRATING [TEVA PHARMACEUTICALS USA INC]11

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 8 of 15 · 285 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sodium BicarbonateSODIUM BICARBONATEBryant Ranch Prepackccf8e08c-2efb-4a92-a4c2-042dba2eacfa2025-08-13Warnings, Adverse reactionsExact identifier
unii: 8MDF5V39QO
Sodium BicarbonateSODIUM BICARBONATEHenry Schein, Inc.ea9ad1a6-84f2-44d8-bf93-fb8f3d3fce9c2025-08-12Warnings, Adverse reactionsExact identifier
unii: 8MDF5V39QO
Bath Bomb 2-pack (Lemon)ALLANTOINCarolina Cannabis Creations LLC08c7c313-cf36-fb46-e063-6294a90a73042025-08-06WarningsExact identifier
unii: 8MDF5V39QO
Omeprazole and Sodium BicarbonateOMEPRAZOLE AND SODIUM BICARBONATEPHOENIX RX LLC3b2bf501-fd81-6ffa-e063-6394a90afe422025-07-30Warnings, Adverse reactionsExact identifier
unii: 8MDF5V39QO
Omeprazole and Sodium BicarbonateOMEPRAZOLE AND SODIUM BICARBONATEPHOENIX RX LLC3b2cf6fd-72cb-fa53-e063-6394a90a674a2025-07-30Warnings, Adverse reactionsExact identifier
unii: 8MDF5V39QO
Anti-EmpachoSODIUM BICARBONATEMenper Distributors, Inc.43807221-58f0-434d-be2d-fa0f54b95db82025-07-22WarningsExact identifier
unii: 8MDF5V39QO
Sodium Bicarbonate AntacidSODIUM BICARBONATEMenper Distributors Inc.6efb4da0-03ae-4df6-acd7-e8023d20d4b32025-07-22WarningsExact identifier
unii: 8MDF5V39QO
ClozapineCLOZAPINEMylan Institutional Inc.976be6e3-a9db-49c6-9b02-1ab168cf17b12025-07-18Boxed warning, Warnings, Adverse reactionsExact identifier
unii: J60AR2IKIC
Aller-Chord FACETALDEHYDE, ACETICUM AC, ARG NIT, CAFFEINUM, CALC SULPH, CITRICUM AC, CORTISONE ACETICUM, ECHINACEA PURP, FOLLICULINUM, FRAGARIA, FUMARICUM AC, GALLICUM AC, GLANDULA SUPRARENALIS SUIS, HEPAR SUIS, HISTAMINUM HYDROCHLORICUM, HYDRANGEA, LAC VAC, LECITHIN, LIMULUS, LYCOPERSICUM, LYCOPODIUM, NAT BICARB, NAT MUR, NUX VOM, PARAFFINUM, PHOSPHORICUM AC, SACCHARUM OFF, SILICEA, TARTARICUM AC, TORULA CEREVISIAE.Energetix Corporationff4eb7b2-8272-4bd3-99a9-7e589b30d59a2025-07-15WarningsExact identifier
unii: 8MDF5V39QO
Zegerid OTCOMEPRAOLE, SODIUM BICARBONATERiley Consumer Care LLC8d00c19a-d86b-4a2f-8791-b320ad3ca7812025-07-15WarningsExact identifier
unii: 8MDF5V39QO
Leader Sinus Wash Saline Refill PacketsSODIUM BICARBONATE, SODIUM CHLORIDECardinal Health, 110 dba LEADERfb192a6d-318e-4d2b-89b6-42ac023e4fbd2025-07-09WarningsExact identifier
unii: 8MDF5V39QO
Sodium BicarbonateSODIUM BICARBONATEWestminster Pharmaceuticals, LLC9dcfc778-5fd6-4c68-8d37-a5385e3746172025-07-08WarningsExact identifier
unii: 8MDF5V39QO
SODIUM BICARBONATESODIUM BICARBONATEAnthea Pharma Private Limited0df8cf62-4b49-4ec4-aae4-c4a3e6d765492025-06-26Warnings, Adverse reactionsExact identifier
unii: 8MDF5V39QO
ClozapineCLOZAPINETeva Pharmaceuticals USA, Inc.6fccf4f7-2e30-4272-9800-225aaef205842025-06-24Boxed warning, Warnings, Adverse reactionsExact identifier
unii: J60AR2IKIC
INFANT 4.2% SODIUM BICARBONATEINFANT 4.2% SODIUM BICARBONATEHF Acquisition Co LLC, DBA HealthFirst78c25911-0042-664e-e053-2a91aa0a57a12025-06-16Warnings, Adverse reactionsExact identifier
unii: 8MDF5V39QO
ClozarilCLOZAPINEHLS Therapeutics (USA), Inc.90876802-0e3a-44c9-9ff7-1754dfbe736a2025-06-06Boxed warning, Warnings, Adverse reactionsExact identifier
unii: J60AR2IKIC
ClozapineCLOZAPINEAurobindo Pharma Limitedcaf2d4a6-2a23-4992-a807-560c4204afc42025-06-05Boxed warning, Warnings, Adverse reactionsExact identifier
unii: J60AR2IKIC
PRISMASOL BGK2/0MAGNESIUM CHLORIDE, DEXTROSE ANHYDROUS, LACTIC ACID, SODIUM CHLORIDE, SODIUM BICARBONATE, AND POTASSIUM CHLORIDEVantive US Healthcare LLC7f675fee-8940-4ece-bb0c-75ac79d8708c2025-05-31Warnings, Adverse reactionsExact identifier
unii: 8MDF5V39QO
AHHH Bite ReliefSODIUM BICARBONATE7827125a1e070-9228-4ec9-e063-6294a90ad78d2025-05-27WarningsExact identifier
unii: 8MDF5V39QO
Bestmade Natural Products Sodium Bicarbonate (Nat Bicarb)SODIUM BICARBONATEBestmade Natural Products2fad1d83-3c64-f1b3-e063-6294a90aa3e52025-05-26WarningsExact identifier
unii: 8MDF5V39QO

Reported adverse events (FAERS/openFDA)#

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