NDC 67457-426-00 - HALOPERIDOL LACTATE

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
67457-426
Requested NDC
67457-426-00
Package NDCs from labels
67457-426-00, 67457-426-12
Manufacturer
REMEDYREPACK INC.
Effective date
2026-07-14
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Haloperidol Injection, USP (For Immediate Release) Rx onlyREMEDYREPACK INC.2026-07-14HUMAN PRESCRIPTION DRUG LABEL
HALOPERIDOL LACTATE - Cardinal Health 107, LLCCardinal Health 107, LLC2026-06-02HUMAN PRESCRIPTION DRUG LABEL
Haloperidol Injection, USP (For Immediate Release) Rx onlyHenry Schein, Inc.2026-03-02HUMAN PRESCRIPTION DRUG LABEL
HALOPERIDOL LACTATE - Mylan Institutional LLCMylan Institutional LLC2024-11-14HUMAN PRESCRIPTION DRUG LABEL
Haloperidol Injection, USP (For Immediate Release) Rx onlyGeneral Injectables and Vaccines, Inc.2022-12-22HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67457-426-00HALOPERIDOL LACTATE1 mL in 1 VIALINJECTION, SOLUTION17
67457-426-12HALOPERIDOL LACTATE25 in 1 CARTONINJECTION, SOLUTION257

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67457-426HALOPERIDOL LACTATE INJECTION, SOLUTION [MYLAN INSTITUTIONAL LLC]7Current NDC, Legacy NDC, 2 package rows20241127_909259a3-7627-4d1e-91d3-3363b3493599.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
67457-426-00ML - Milliliter67457-4267aa96693-7d16-4c43-a208-ee09f7595ddc12014-05-02
67457-426-12ML - Milliliter67457-4265798c7d2-3824-46fd-a270-88816e6c716812014-05-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
HALOPERIDOL LACTATEACTIVE INGREDIENT6387S86PK3HALOPERIDOL LACTATE INJECTION, SOLUTION [CARDINAL HEALTH]2
HALOPERIDOLACTIVE MOIETYJ6292F8L3DHALOPERIDOL LACTATE INJECTION, SOLUTION [CARDINAL HEALTH]2
LACTIC ACIDINACTIVE INGREDIENT33X04XA5ATHALOPERIDOL LACTATE INJECTION, SOLUTION [CARDINAL HEALTH]2
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9THALOPERIDOL LACTATE INJECTION, SOLUTION [CARDINAL HEALTH]2
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHHALOPERIDOL LACTATE INJECTION, SOLUTION [CARDINAL HEALTH]2
WATERINACTIVE INGREDIENT059QF0KO0RHALOPERIDOL LACTATE INJECTION, SOLUTION [CARDINAL HEALTH]2
HALOPERIDOL LACTATEACTIVE INGREDIENT6387S86PK3HALOPERIDOL LACTATE (HALOPERIDOL) INJECTION [GENERAL INJECTABLES AND VACCINES, INC.]1
HALOPERIDOL LACTATEACTIVE INGREDIENT6387S86PK3HALOPERIDOL LACTATE INJECTION, SOLUTION [MYLAN INSTITUTIONAL LLC ]1
HALOPERIDOLACTIVE MOIETYJ6292F8L3DHALOPERIDOL LACTATE (HALOPERIDOL) INJECTION [GENERAL INJECTABLES AND VACCINES, INC.]1
HALOPERIDOLACTIVE MOIETYJ6292F8L3DHALOPERIDOL LACTATE INJECTION, SOLUTION [MYLAN INSTITUTIONAL LLC ]1
LACTIC ACIDINACTIVE INGREDIENT33X04XA5ATHALOPERIDOL LACTATE INJECTION, SOLUTION [MYLAN INSTITUTIONAL LLC ]1
LACTIC ACIDINACTIVE INGREDIENT33X04XA5ATHALOPERIDOL LACTATE (HALOPERIDOL) INJECTION [GENERAL INJECTABLES AND VACCINES, INC.]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9THALOPERIDOL LACTATE (HALOPERIDOL) INJECTION [GENERAL INJECTABLES AND VACCINES, INC.]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9THALOPERIDOL LACTATE INJECTION, SOLUTION [MYLAN INSTITUTIONAL LLC ]1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHHALOPERIDOL LACTATE (HALOPERIDOL) INJECTION [GENERAL INJECTABLES AND VACCINES, INC.]1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHHALOPERIDOL LACTATE INJECTION, SOLUTION [MYLAN INSTITUTIONAL LLC ]1
WATERINACTIVE INGREDIENT059QF0KO0RHALOPERIDOL LACTATE (HALOPERIDOL) INJECTION [GENERAL INJECTABLES AND VACCINES, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RHALOPERIDOL LACTATE INJECTION, SOLUTION [MYLAN INSTITUTIONAL LLC ]1

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 1 of 10 · 195 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
KUGIG ALOE FOAMING INTIMATE WASHINTIMATE CLEANSING FOAMHong Kong KangXing Centennial Management Limited59f4d398-1186-a168-e063-6294a90ab44b2026-08-26WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERREMEDYREPACK INC.5dd5d148-6e23-41de-bff5-551b2aea95982026-08-24Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
BM BM63 DROPSCEANOTHUS, KALI ARSEN, KALI MUR, SELENIUM, THALLIUM, WIESBADENBM Private Limited59006d82-610a-2e08-e063-6394a90af1ed2026-08-14WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERCardinal Health 107, LLC48d75a7c-8329-48a8-bea0-a8c144ddf6372026-08-07Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
GarzulysINSULIN ASPART-FSANMeitheal Pharmaceuticals Inc.30c64769-d2f7-4604-ac9e-2a6bc09506c92026-07-31Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
DECONIMO ReconstitutionDECONIMO RECONSTITUTIONImage Amazon LLC57ab9b1c-9a18-3786-e063-6394a90a2c632026-07-28WarningsExact identifier
unii: 059QF0KO0R
PRENATE RestoreASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, DL-, FOLIC ACID, PYRIDOXINE HYDROCHLORIDE, CYANOCOBALAMIN, BIOTIN, CALCIUM CARBONATE, FERROUS FUMARATE, MAGNESIUM OXIDE, LACTIC ACID AND DOCONEXENTAvion Pharmaceuticals, LLC1076ba9a-0168-492f-ba9b-99fa021860922026-07-23Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 33X04XA5AT
Sterile WaterWATERCardinal Health 107, LLC9655cd02-82b5-4a75-813b-854b195514812026-07-21Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
HALOPERIDOL LACTATEHALOPERIDOL LACTATEREMEDYREPACK INC.4289f7db-e25d-4578-8adf-f0222ae64aa62026-07-14Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA078347
ndc (package): 70518-1053-0
ndc (package): 70518-1053-1
ndc (product): 70518-1053
rxcui: 1719646
spl id: 5691b7c8-84a0-430f-e063-6394a90a35b6
spl set id: 4289f7db-e25d-4578-8adf-f0222ae64aa6
unii: 6387S86PK3
Dr. Drop NMN Vital Balance (Drop No.1 Cream 90g)NMN (NICOTINAMIDE MONONUCLEOTIDE), ECTOIN (ECTOINE)Reedfresh Co., LTD55d703ca-ff9d-0dbc-e063-6294a90ab6b12026-07-05WarningsExact identifier
unii: 059QF0KO0R
Eyesaline Eyewash ConcentratePURIFIED WATERProtective Industrial Products, Inc.558e5926-9027-d3f6-e063-6294a90ab1212026-07-02WarningsExact identifier
unii: 059QF0KO0R
Fendall 2000 Pure FlowPURIFIED WATERProtective Industrial Products, Inc.55a1d07e-0006-0c75-e063-6394a90a7acc2026-07-02WarningsExact identifier
unii: 059QF0KO0R
SKIN TAG REMOVERSALICYLIC ACIDGuangzhou ChuanMa International Trading Co.,Ltd.3a5e2105-7125-183c-e063-6394a90ae8792026-07-02WarningsExact identifier
unii: 33X04XA5AT
WART SKIN TAG REMOVERSALICYLIC ACIDGuangzhou ChuanMa International Trading Co.,Ltd.3a5b64a3-b19e-8b1a-e063-6294a90a66412026-07-02WarningsExact identifier
unii: 33X04XA5AT
Fendall 1000 Pure FlowPURIFIED WATERProtective Industrial Products, Inc.55a2f4da-bb1e-8ead-e063-6394a90af72e2026-07-02WarningsExact identifier
unii: 059QF0KO0R
Sterile Eyesaline EyewashSTERILE EYESALINE EYEWASHProtective Industrial Products, Inc.55a290e8-8310-8be4-e063-6394a90abdce2026-07-02WarningsExact identifier
unii: 059QF0KO0R
Eyesaline Emergency EyewashPURIFIED WATERProtective Industrial Products, Inc.55a261c2-725d-6765-e063-6294a90a32602026-07-02WarningsExact identifier
unii: 059QF0KO0R
RemodulinTREPROSTINILUnited Therapeutics Corporation6c80bb38-e8db-4138-9f0d-dbbf9c6731852026-07-02Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Fendall 2000 Pure FlowPURIFIED WATERHoneywell Safety Products USA, Inc.37dead3e-60cb-88ae-e063-6294a90a8f702026-06-24WarningsExact identifier
unii: 059QF0KO0R
Bacteriostatic WaterBACTERIOSTATIC WATERFujian Genohope Biotech Ltd.54f66b82-c9e5-a2bc-e063-6394a90adbbc2026-06-23Exact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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