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 2 of 63 · 1,244 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Bio Combination 28SCHUESSLER SALTSLDD Bioscience Private Limited597caf33-5107-9dec-e063-6294a90a5fcd2026-08-20WarningsExact identifier
unii: 451W47IQ8X
Sodium ChlorideSODIUM CHLORIDEYYBA CORP597f3347-647c-3545-e063-6294a90abab22026-08-20WarningsExact identifier
unii: 451W47IQ8X
Sodium ChlorideSODIUM CHLORIDEFresenius Kabi USA, LLC2e5fe9f4-78e5-4af4-8bf9-9680e5dc5e882026-08-20Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Sinusforce-HPARSENICUM ALBUM, HEPAR SULPHURIS CALCAREUM, KALI BICHROMICUM, LYCOPODIUM CLAVATUM, MERCURIUS SOLUBILIS, NATRUM MURIATICUM, PHOSPHORUS, PULSATILLA (PRATENSIS), SEPIABioActive Nutritional, Inc.53c96680-210b-4426-8b41-3b9a882848dd2026-08-20WarningsExact identifier
unii: 451W47IQ8X
CVS SalineNASALCVS PHARMACYf02c41b0-c78e-41cd-aa4a-2756bbe920872026-08-19WarningsExact identifier
unii: 451W47IQ8X
Ascorbic AcidASCORBIC ACIDRenova Pharmaceuticals LLCa6481bae-2397-44c7-a51d-4f47ad91bd2c2026-08-19Warnings, Adverse reactionsExact identifier
unii: PQ6CK8PD0R
ChlorpromazineCHLORPROMAZINEREMEDYREPACK INC.0dc38655-01b1-413e-9139-2466014cb4d02026-08-19Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9WP59609J6
Dextrose and Sodium ChlorideDEXTROSE MONOHYDRATE AND SODIUM CHLORIDEFresenius Kabi USA, LLCdf18a603-ca12-4b26-83b5-9dd07b6453ab2026-08-18Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
DELFLEXDEXTROSE MONOHYDRATE, SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDEFresenius Medical Care Renal Therapies Group, LLCbbc5b820-4973-11e2-a192-0002a5d5c51b2026-08-18Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
DELFLEXDEXTROSE MONOHYDRATE, SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDEFresenius Medical Care Renal Therapies Group, LLCc29bdfa0-4976-11e2-939b-0002a5d5c51b2026-08-18Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
DELFLEXDEXTROSE MONOHYDRATE, SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDEFresenius Medical Care Renal Therapies Group, LLC515dcee0-3e34-11e2-a25f-0800200c9a662026-08-18Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
BM BM63 DROPSCEANOTHUS, KALI ARSEN, KALI MUR, SELENIUM, THALLIUM, WIESBADENBM Private Limited59006d82-610a-2e08-e063-6394a90af1ed2026-08-14WarningsExact identifier
unii: 059QF0KO0R
Chlorpromazine HydrochlorideCHLORPROMAZINE HYDROCHLORIDEREMEDYREPACK INC.41b86f9d-d7e2-4296-8d88-e8257c7cbed22026-08-14Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9WP59609J6
BM BM173 DROPSECHINACEA, EUPHRASIA, NATRUM MUR, RHUS TOX, SILICEA, SULPHUR, URTICA URENBM Private Limited59036ca4-e7bb-bbe7-e063-6394a90a410a2026-08-14WarningsExact identifier
unii: 451W47IQ8X
Natural Lift Lack of energy - FatigueAVENA SATIVA 9C, GELSEMIUM SEMPERVIRENS 9C, PANAX GINSENG 3C, NATRUM MURIATICUM 9CSEVENE USA551194c4-dfd8-c42d-e063-6294a90aecee2026-08-13WarningsExact identifier
unii: 451W47IQ8X
BM BM59 DROPSCALC CARB, DULCAMARA, HEPAR SULPH, LYCOPODIUM, NAT MUR, SULPHUR, THUJA OCCBM Private Limited58ef0755-c2cd-b7c2-e063-6294a90a27072026-08-13WarningsExact identifier
unii: 451W47IQ8X
Chlorpromazine HydrochlorideCHLORPROMAZINE HYDROCHLORIDEREMEDYREPACK INC.2122d619-3f5b-48f6-8f0b-7693199abbdb2026-08-11Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9WP59609J6
Adrenal-ToneADRENALINUM, AVENA, GINKGO, GLYCYRRHIZA, KALI PHOS, NAT MUR, NUX VOMICA, PHOSPHORICUM AC, PITUITARUM POSTERIUM, SARSAPARILLA, THYROIDINUM, VERATRUM ALB, ZINC MET.Energetix Corporation1ea4abb3-3a02-4d5c-baeb-d903b0febbb52026-08-11WarningsExact identifier
unii: 451W47IQ8X
AdrenapathCARDUUS MARIANUS, CHELIDONIUM MAJUS, ECHINACEA (ANGUSTIFOLIA), GLANDULA SUPRARENALIS SUIS, NATRUM MURIATICUM, PHOSPHORICUM ACIDUM, PITUITARUM POSTERIUM (BOVINE), THYROIDINUM (BOVINE)Energetix Corporationc300b8f5-4334-4597-a303-8200cbc117d12026-08-11WarningsExact identifier
unii: 451W47IQ8X
Lymph-Tone IIAESCULUS HIPP, AZADIRACHTA, BARYTA CARB, BERBER VULG, BOLDO, BUFO, CALC CARB, CALC PHOS, COENZYME A, COLLINSONIA, ECHINACEA, FERRUM PHOS, GLANDULA SUPRARENALIS SUIS, HYPOTHALAMUS, KREOSOTUM, NADIDUM, NAT MUR, PHOS, PHYTOLACCA, PINUS SYL, PITUITARUM POSTERIUM, PIX LIQUIDA, PULSATILLA, SILICEA, STILLINGIA, THUJA OCC.Energetix Corporationc46aa8d3-4aa5-4e07-be3d-d71abc5e24072026-08-11WarningsExact identifier
unii: 451W47IQ8X

Reported adverse events (FAERS/openFDA)#

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