FDA.reportPublic FDA data

NDC 0641-1397-31 - CHLORPROMAZINE HYDROCHLORIDE

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
0641-1397
Requested NDC
0641-1397-31
Package NDCs from labels
0641-1397-31, 0641-1397-35
Manufacturer
Henry Schein, Inc.
Effective date
2025-10-27
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Chlorpromazine Hydrochloride Injection, USP Rx OnlyHenry Schein, Inc.2025-10-27HUMAN PRESCRIPTION DRUG LABEL
Chlorpromazine Hydrochloride Injection, USPHikma Pharmaceuticals USA Inc. | HIKMA FARMACEUTICA (PORTUGAL), S.A2024-04-08HUMAN PRESCRIPTION DRUG LABEL
Chlorpromazine Hydrochloride Injection, USP Rx OnlyGeneral Injectables and Vaccines, Inc.2022-12-14HUMAN PRESCRIPTION DRUG LABEL
Chlorpromazine hydrochloride - TYA PharmaceuticalsTYA Pharmaceuticals2012-06-13HUMAN PRESCRIPTION DRUG LABEL
National Council for Prescription Drug Programs indexing - billing unitNational Council for Prescription Drug Programs2012-07-24Indexing - Billing Unit

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0641-1397-31Chlorpromazine hydrochloride1 mL in 1 AMPULEINJECTION113
0641-1397-35Chlorpromazine hydrochloride25 in 1 CARTONINJECTION2513

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0641-1397CHLORPROMAZINE HYDROCHLORIDE INJECTION [HIKMA PHARMACEUTICALS USA INC.]13Current NDC, Legacy NDC, 2 package rows20240410_c0f1fcfd-8863-4032-bf80-185df60a4ba0.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0641-1397-31ML - Milliliter0641-1397275f17e3-5cc2-43c4-a4f7-03ed477c418612012-07-24
0641-1397-35ML - Milliliter0641-1397bd64ef0c-307d-435d-99ed-3e675e95d3a212012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CHLORPROMAZINE HYDROCHLORIDEACTIVE INGREDIENT9WP59609J6CHLORPROMAZINE HYDROCHLORIDE INJECTION [WEST-WARD PHARMACEUTICAL CORP.]7
CHLORPROMAZINEACTIVE MOIETYU42B7VYA4PCHLORPROMAZINE HYDROCHLORIDE INJECTION [WEST-WARD PHARMACEUTICAL CORP.]7
ASCORBIC ACIDINACTIVE INGREDIENTPQ6CK8PD0RCHLORPROMAZINE HYDROCHLORIDE INJECTION [WEST-WARD PHARMACEUTICAL CORP.]7
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XCHLORPROMAZINE HYDROCHLORIDE INJECTION [WEST-WARD PHARMACEUTICAL CORP.]7
SODIUM METABISULFITEINACTIVE INGREDIENT4VON5FNS3CCHLORPROMAZINE HYDROCHLORIDE INJECTION [WEST-WARD PHARMACEUTICAL CORP.]7
SODIUM SULFITEINACTIVE INGREDIENTVTK01UQK3GCHLORPROMAZINE HYDROCHLORIDE INJECTION [WEST-WARD PHARMACEUTICAL CORP.]7
WATERINACTIVE INGREDIENT059QF0KO0RCHLORPROMAZINE HYDROCHLORIDE INJECTION [WEST-WARD PHARMACEUTICAL CORP.]7
CHLORPROMAZINE HYDROCHLORIDEACTIVE INGREDIENT9WP59609J6CHLORPROMAZINE HYDROCHLORIDE INJECTION [TYA PHARMACEUTICALS]2
CHLORPROMAZINEACTIVE MOIETYU42B7VYA4PCHLORPROMAZINE HYDROCHLORIDE INJECTION [TYA PHARMACEUTICALS]2
ASCORBIC ACIDINACTIVE INGREDIENTPQ6CK8PD0RCHLORPROMAZINE HYDROCHLORIDE INJECTION [TYA PHARMACEUTICALS]2
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XCHLORPROMAZINE HYDROCHLORIDE INJECTION [TYA PHARMACEUTICALS]2
SODIUM METABISULFITEINACTIVE INGREDIENT4VON5FNS3CCHLORPROMAZINE HYDROCHLORIDE INJECTION [TYA PHARMACEUTICALS]2
SODIUM SULFITEINACTIVE INGREDIENTVTK01UQK3GCHLORPROMAZINE HYDROCHLORIDE INJECTION [TYA PHARMACEUTICALS]2
WATERINACTIVE INGREDIENT059QF0KO0RCHLORPROMAZINE HYDROCHLORIDE INJECTION [TYA PHARMACEUTICALS]2

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 9 of 63 · 1,244 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Migraine and HeadacheIRIS VERSICOLOR ROOT AND SODIUM CHLORIDEForces of Nature0dd2f2e2-78e2-435e-b7b2-ca590953ff942026-04-01WarningsExact identifier
unii: 451W47IQ8X
Cold Sore FormulaDULCAMARA, GLYCYRRHIZA GLABRA, RANUNCULUS BULBOSUS, RHUS TOX, NATRUM MURIATICUM, FAGOPYRUM ESCULENTUM, NATRUM MURIATICUM, ACONITUM NAPELLUS, CYTOMEGALOVIRUS NOSODE, HERPES SIMPLEX I AND II NOSODE, SEPIA, EPSTEIN BARR VIRUS NOSODE, HERPES ZOSTER NOSODE, ADENOVIREN NOSODENutritional Specialties, Inc.f4e7e469-baaf-4c61-af44-80b0832eadf02026-03-31WarningsExact identifier
unii: 451W47IQ8X
Sodium Chloride Normal SaltSODIUM CHLORIDETWIN MED LLC10230c8a-e5e5-44f1-b41d-80930899d6b92026-03-31WarningsExact identifier
unii: 451W47IQ8X
H-Allergy FormulaALLIUM CEPA, AMBROSIA ARTEMISIAEFOLIA, ARUM TRIPHYLLUM, ARUNDO MAURITANICA, EUPHRASIA OFFICINALIS, GALPHIMIA GLAUCA, HISTAMINUM HYDROCHLORICUM, KALI BICHROMICUM, NATRUM MURIATICUM, SOLIDAGO VIRGAUREA, STICTA PULMONARIA, SULPHUR, TRIFOLIUM PRATENSE, WYETHIA HELENIOIDESHealing Natural Oils LLC4e586360-b3c4-1ce0-e063-6394a90ab6b82026-03-31WarningsExact identifier
unii: 451W47IQ8X
Acne HPCARBO ANIMALIS, CARBO VEGETABILIS, KALI BICHROMICUM, NATRUM MURIATICUM, PULSATILLA (VULGARIS), SEPIA, SILICEA, SULPHUR, ZINCUM METALLICUMBioActive Nutritional, Inc.2ab4ff53-4274-40c7-b05c-44d918d809be2026-03-31WarningsExact identifier
unii: 451W47IQ8X
Cold Sore FormulaDULCAMARA, GLYCYRRHIZA GLABRA, RANUNCULUS BULBOSUS, RHUS TOX, NATRUM MURIATICUM, FAGOPYRUM ESCULENTUM, NATRUM HYPOCHLOROUS, ACONITUM NAPELLUS, CYTOMEGALOVIRUS NOSODE, HERPES SIMPLEX I AND II NOSODE, SEPIA, EPSTEIN BARR VIRUS NOSODE, HERPES ZOSTER NOSODE, ADENOVIREN NOSODENutritional Specialties, Inc.ad6a08ec-5eba-405b-8a07-79ac86ab3e7a2026-03-31WarningsExact identifier
unii: 451W47IQ8X
ANX HPARSENICUM ALBUM, CALCAREA CARBONICA, IGNATIA AMARA, KALI CARBONICUM, LACHESIS MUTUS, NATRUM MURIATICUMBioActive Nutritional, Inc.96035891-aea3-4138-bb26-801ad819f6392026-03-30WarningsExact identifier
unii: 451W47IQ8X
Spleen LiquescenceQUERCUS ROBUR, CEANOTHUS AMERICANUS, SPLEEN (BOVINE), NATRUM MURIATICUM, HELIANTHUS ANNUUSNutritional Specialties, Inc.d800456d-60f0-413d-b310-91b8b881f6b92026-03-30WarningsExact identifier
unii: 451W47IQ8X
Multivitamin with Fluoride.ALPHA.-TOCOPHEROL ACETATE, DL-, ASCORBIC ACID, CYANOCOBALAMIN, FOLIC ACID, NIACIN, PYRIDOXINE, RIBOFLAVIN, SODIUM FLUORIDE, THIAMINE MONONITRATE, VITAMIN A AND VITAMIN DBryant Ranch Prepack696cb342-fc5c-47cf-bbc8-5ecc706074c02026-03-27Warnings, Adverse reactionsExact identifier
unii: PQ6CK8PD0R
Multivitamin with Fluoride.ALPHA.-TOCOPHEROL ACETATE, DL-, ASCORBIC ACID, CYANOCOBALAMIN, FOLIC ACID, NIACIN, PYRIDOXINE, RIBOFLAVIN, SODIUM FLUORIDE, THIAMINE MONONITRATE, VITAMIN A AND VITAMIN DBryant Ranch Prepack0800f4ef-1d98-4c0f-a016-501791973f662026-03-27Warnings, Adverse reactionsExact identifier
unii: PQ6CK8PD0R
Multivitamin with Fluoride.ALPHA.-TOCOPHEROL ACETATE, DL-, ASCORBIC ACID, CYANOCOBALAMIN, FOLIC ACID, NIACIN, PYRIDOXINE, RIBOFLAVIN, SODIUM FLUORIDE, THIAMINE MONONITRATE, VITAMIN A AND VITAMIN DBryant Ranch Prepack0f11c8c7-c73e-4610-83ed-e697539ac1802026-03-27Warnings, Adverse reactionsExact identifier
unii: PQ6CK8PD0R
Tri-Vite Drops with FluorideASCORBIC ACID, SODIUM FLUORIDE, VITAMIN A AND VITAMIN DBryant Ranch Prepack15c78a03-17d7-43af-978f-1a64bd2240fe2026-03-27Warnings, Adverse reactionsExact identifier
unii: PQ6CK8PD0R
DepressoforcePICRICUM ACIDUM, ARSENICUM ALBUM, AURUM METALLICUM, IGNATIA AMARA, NATRUM MURIATICUM, NITRICUM ACIDUM, PULSATILLA (PRATENSIS), SEPIABioActive Nutritional, Inc.e6b98979-a38c-4f13-af03-f5ffa962b4fa2026-03-27WarningsExact identifier
unii: 451W47IQ8X
M-Natal PlusVITAMIN A, VITAMIN C, VITAMIN D, VITAMIN E, THIAMINE, RIBOFLAVIN, NIACIN, VITAMIN B6, FOLIC ACID, VITAMIN B12, CALCIUM, IRON, ZINC, COPPERBryant Ranch Prepack790a9ec0-eb61-4148-86e9-91439e4dce892026-03-27WarningsExact identifier
unii: PQ6CK8PD0R
AdrenaparARALIA QUINQUEFOLIA, AVENA SATIVA, GLANDULA SUPRARENALIS SUIS, HYPOTHALAMUS SUIS, ARSENICUM IODATUM, CALCAREA CARBONICA, IGNATIA AMARA, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, NUX VOMICA, PHOSPHORICUM ACIDUM, PHOSPHORUS, ZINCUM METALLICUMEnergique, Inc.077a9171-283d-47b6-bddc-34c739f6d69d2026-03-27WarningsExact identifier
unii: 451W47IQ8X
Buffer pHCHAMOMILLA, GRAPHITES, KALI CARBONICUM, KALI OXALICUM, KALI PHOSPHORICUM, MAGNESIA PHOSPHORICA, NATRUM MURIATICUM, NATRUM PHOSPHORICUM, NATRUM SULPHURICUM, NUX VOMICA, RHEUM (PALMATUM), ROBINIA PSEUDOACACIANaturalCare2161a2e2-613d-4dac-a5f6-796d40e849d92026-03-25WarningsExact identifier
unii: 451W47IQ8X
Reflux AwayABIES NIGRA, ANTIMONIUM CRUDUM, ARGENTUM NITRICUM, CARBO VEGETABILIS, CHELIDONIUM MAJUS, COLOCYNTHIS, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, NUX VOMICANaturalCare8a00a72f-60df-4477-b7b8-abb6355e34da2026-03-24WarningsExact identifier
unii: 451W47IQ8X
Worafy Gentle Eye WashSODIUM CHLORIDEShenzhen Shandian Jingling Technology Co., Ltd.4da864dc-e10c-1db9-e063-6394a90a09842026-03-22WarningsExact identifier
unii: 451W47IQ8X
SODIUM CHLORIDE HYPERTONICITYSODIUM CHLORIDEYYBA CORP439653b9-99b8-4799-8d67-4a2ada9c67832026-03-20WarningsExact identifier
unii: 451W47IQ8X
Sterile WaterWATERHospira, Inc.2b9ea23a-f9e9-48a8-25b7-519e3bbd68282026-03-18Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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