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 4 of 15 · 285 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SODIUM BICARBONATESODIUM BICARBONATEAmneal Pharmaceuticals Private Limitedba92f45a-0187-4709-aa70-462b8dae09e92026-02-09Warnings, Adverse reactionsExact identifier
unii: 8MDF5V39QO
Additive Formula 3DEXTROSE MONOHYDRATE, TRISODIUM CITRATE DIHYDRATE, SODIUM CHLORIDE, SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE, CITRIC ACID MONOHYDRATE, AND ADENINETerumo BCT, Ltd9a5247a1-cc05-442d-b2d0-950f887f03c22026-01-30Warnings, Adverse reactionsExact identifier
unii: 2968PHW8QP
ADRIAN BICARBONATO SODIUM BICARBONATE USP-4 oz, 8 oz and 16 ozSODIUM BICARBONATEEvi Labs4979a339-4ad4-9cdd-e063-6394a90a0acc2026-01-28WarningsExact identifier
unii: 8MDF5V39QO
Equate Comfort Flow Sinus washSINUS WASHWALMART INC9e911eef-ca99-9902-e053-2a95a90aab0e2026-01-19WarningsExact identifier
unii: 8MDF5V39QO
SWISS BLEU Relief-Calm Antimicrobial Skin CreamLACTOBACILLUS FERMENT LYSATE, LEONTOPODIUM ALPINUM, CALENDULA OFFICINALIS FLOWER EXTRACT, EVENING PRIMROSE FLOWER EXTRACT, CITRIC ACIDNanjing Hongruixing Biological Technology Co., Ltd487d3c2c-ce28-f7a1-e063-6294a90a5ec62026-01-16WarningsExact identifier
unii: 2968PHW8QP
D-D SUDIUM BICARBONATE U.S.P. BICARBONATO DE SODA PUROSODIUM BICARBONATEEvi Labs485f9eb1-6535-c47c-e063-6394a90ae32c2026-01-14WarningsExact identifier
unii: 8MDF5V39QO
Artificial Sweetener Detox 6034ARTIFICIAL SWEETENER DETOXProfessional Complementary Health Formulas38f2ae0b-2b1f-4b49-934d-fe1556f84d932026-01-08WarningsExact identifier
unii: Z0H242BBR1
Sanar Baking Soda 8oz 100% pureSODIUM BICARBONATEEvi Labs47e7f801-3176-288c-e063-6394a90abef42026-01-08WarningsExact identifier
unii: 8MDF5V39QO
Thio Combination 9306THIO COMBINATIONProfessional Complementary Health Formulas36e84795-bfb4-4483-9a2c-e14131ce1bea2026-01-08WarningsExact identifier
unii: Z0H242BBR1
DR. SANA BICARBONATO DE SODIO 4 Fl oz and 6 FlozSODIUM BICARBONATEEvi Labs47330d09-7db1-254d-e063-6294a90ae7de2026-01-07WarningsExact identifier
unii: 8MDF5V39QO
DE LA CRUZ SODIUM BICARBONATE ANTACIDSODIUM BICARBONATEDLC Laboratories, Inc.fc469943-9749-45ee-93f7-90fdbcdc72152026-01-07WarningsExact identifier
unii: 8MDF5V39QO
De La Cruz DesempachoSODIUM BICARBONATEDLC LABORATORIES, INC.741e105a-3ed2-4fc7-ab06-273e515a2d162026-01-07WarningsExact identifier
unii: 8MDF5V39QO
CLOZAPINECLOZAPINEMajor Pharmaceuticals9db7aefb-f607-4158-a310-181e631bc6482026-01-05Boxed warning, Warnings, Adverse reactionsExact identifier
unii: J60AR2IKIC
Sodium Bicarbonate 10 grSODIUM BICARBONATEGRAXCELL PHARMACEUTICAL, LLC897dbb09-fb47-4e03-8cae-bf76d48a7a032025-12-25WarningsExact identifier
unii: 8MDF5V39QO
Zegerid OTCOMEPRAZOLE, SODIUM BICARBONATERiley Consumer Care LLC1d764fc5-8eae-4fc9-a2e9-3f1954a3ac052025-12-24WarningsExact identifier
unii: 8MDF5V39QO
Sterile Cord Blood Collection Unit (MSC128D)ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE SOLUTIONMaco Productions251fd4cb-4aa4-4473-9f89-968da856eb772025-12-18WarningsExact identifier
unii: 2968PHW8QP
Sterile Cord Blood Collection Unit (MSC127D)ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE SOLUTIONMaco Productions75a008b2-9666-4bfa-ab18-6d09b43b22152025-12-18WarningsExact identifier
unii: 2968PHW8QP
Pall Sterile Cord Blood Collection UnitSTERILE CORD BLOOD COLLECTION UNITGlobal Life Sciences Solutions USA LLCaa9340b7-cc63-e17d-e053-2a95a90ad4d92025-12-18WarningsExact identifier
unii: 2968PHW8QP
SODIUM BICARBONATESODIUM BICARBONATEProPharma Distribution3867f743-c2cf-a646-e063-6394a90a82e12025-12-18Warnings, Adverse reactionsExact identifier
unii: 8MDF5V39QO
After Bite AdvancedSODIUM BICARBONATETender Corporation d/b/a Adventure Ready Brands223d1de8-7940-bbdc-e063-6294a90a51d82025-12-18WarningsExact identifier
unii: 8MDF5V39QO

Reported adverse events (FAERS/openFDA)#

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