Haloperidol Lactate

Product NDC
0404-9871
11-digit product format
004049871
Labeler code
0404
Product ID
0404-9871_74d33642-a53d-4042-aa8f-87460d97fd9f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Haloperidol
Dosage form
INJECTION, SOLUTION
Route
INTRAMUSCULAR
Labeler
Henry Schein, Inc.
Application
ANDA078347
Marketing category
ANDA
Marketing start
2022-01-11
Substance
HALOPERIDOL LACTATE
Active strength
5 mg/mL
Pharmacologic classes
Typical Antipsychotic [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Haloperidol Lactate
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HALOPERIDOL LACTATE5 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6387S86PK3
Rxcui1719646

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d599bae4-cb25-0798-7468-31aa188fb750Product name720260304
6aae29ef-bf3c-3ebb-3bf1-10ee5424a22eProduct name220250114
af58e43a-5792-c2c1-8e57-a2454df1f2c0Product name320240202
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
ce329990-eb12-45a5-87d5-ce5ef054ca71Product name220190930
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
597b1cfd-7b31-5048-62be-ca5cd740da2fProduct name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0404-9871-01Haloperidol Lactate1 mL in 1 VIALINJECTION, SOLUTION17
0404-9871-01Haloperidol Lactate1 in 1 BAGINJECTION, SOLUTION17

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0404-9871HALOPERIDOL LACTATE (HALOPERIDOL) INJECTION, SOLUTION [HENRY SCHEIN, INC.]5Current NDC, Legacy NDC, 2 package rows20240502_65df5d2d-79aa-41d4-866a-566e520320f7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1719646haloperidol 5 MG in 1 ML InjectionPSN65df5d2d-79aa-41d4-866a-566e520320f77
17196461 ML haloperidol 5 MG/ML InjectionSCD65df5d2d-79aa-41d4-866a-566e520320f77
1719646haloperidol (as haloperidol lactate) 5 MG per 1 ML InjectionSY65df5d2d-79aa-41d4-866a-566e520320f77

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0404-9871-01004049871011 VIAL in 1 BAG (0404-9871-01) / 1 mL in 1 VIAL1 vial2022-01-110000-00-00NoNoCurrent