FDA.reportPublic FDA data

NDC 63323-474-00 - Haloperidol

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
63323-474
Requested NDC
63323-474-00
Package NDCs from labels
63323-474-00, 63323-474-01, 63323-474-10
Manufacturer
Fresenius Kabi USA, LLC
Effective date
2026-09-22
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Haloperidol - Fresenius Kabi USA, LLCFresenius Kabi USA, LLC2026-09-22HUMAN PRESCRIPTION DRUG LABEL
Haloperidol - Cardinal Health 107, LLCCardinal Health 107, LLC2026-06-18HUMAN PRESCRIPTION DRUG LABEL
Haloperidol Injection, USPREMEDYREPACK INC.2026-03-12HUMAN PRESCRIPTION DRUG LABEL
HALOPERIDOL - HF Acquisition Co LLC, DBA HealthFirstHF Acquisition Co LLC, DBA HealthFirst2021-03-29HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63323-474-00Haloperidol1 mL in 1 VIALINJECTION, SOLUTION111
63323-474-01Haloperidol25 in 1 TRAYINJECTION, SOLUTION2511
63323-474-10Haloperidol10 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION1011
63323-474-10Haloperidol1 in 1 BOXINJECTION, SOLUTION111

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63323-474HALOPERIDOL (HALOPERIDOL LACTATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC ]11Current NDC, Legacy NDC, 4 package rows20220224_b1ad2abd-a9d6-44e3-957b-36a73260f4f5.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63323-474-00ML - Milliliter63323-4749065ab7c-de6d-4eaa-b2e8-8d70536c81b212021-05-05
63323-474-01ML - Milliliter63323-474067113e7-9b23-4828-bb0c-14f7be9a921812012-07-24
63323-474-10ML - Milliliter63323-4743eb1f47a-86e3-4770-a80b-fdd8665b72a812012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
HALOPERIDOL LACTATEACTIVE INGREDIENT6387S86PK3HALOPERIDOL (HALOPERIDOL LACTATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]4
HALOPERIDOLACTIVE MOIETYJ6292F8L3DHALOPERIDOL (HALOPERIDOL LACTATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]4
LACTIC ACIDINACTIVE INGREDIENT33X04XA5ATHALOPERIDOL (HALOPERIDOL LACTATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]4
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9THALOPERIDOL (HALOPERIDOL LACTATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]4
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHHALOPERIDOL (HALOPERIDOL LACTATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]4
HALOPERIDOL LACTATEACTIVE INGREDIENT6387S86PK3HALOPERIDOL (HALOPERIDOL LACTATE) INJECTION, SOLUTION [CARDINAL HEALTH]3
HALOPERIDOLACTIVE MOIETYJ6292F8L3DHALOPERIDOL (HALOPERIDOL LACTATE) INJECTION, SOLUTION [CARDINAL HEALTH]3
LACTIC ACIDINACTIVE INGREDIENT33X04XA5ATHALOPERIDOL (HALOPERIDOL LACTATE) INJECTION, SOLUTION [CARDINAL HEALTH]3
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9THALOPERIDOL (HALOPERIDOL LACTATE) INJECTION, SOLUTION [CARDINAL HEALTH]3
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHHALOPERIDOL (HALOPERIDOL LACTATE) INJECTION, SOLUTION [CARDINAL HEALTH]3

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 3 of 3 · 41 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Glucose Control T015SYZYGIUM JAMBOLANUM, GLANDULA SUPRARENALIS SUIS, HYDRASTIS CANADENSIS, HYPOPHYSIS SUIS, PANCREAS SUIS, PHASEOLUS, ACETICUM ACIDUM, LACTICUM ACIDUM, PHOSPHORICUM ACIDUM, PHOSPHORUS, URANIUM NITRICUMGuangzhou Renuma Medical Systems Co., Ltd3fd02c0a-5cf1-4f35-86d0-d5d09e63f39b2017-10-26WarningsExact identifier
unii: 33X04XA5AT

Reported adverse events (FAERS/openFDA)#

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