Haloperidol

Product NDC
0143-9319
11-digit product format
001439319
Labeler code
0143
Product ID
0143-9319_b93ee0dc-a484-402b-8345-3d68ba0c689a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Haloperidol lactate
Dosage form
INJECTION
Route
INTRAMUSCULAR
Labeler
Hikma Pharmaceuticals USA Inc.
Application
ANDA075858
Marketing category
ANDA
Marketing start
2018-09-14
Substance
HALOPERIDOL LACTATE
Active strength
5 mg/mL
Pharmacologic classes
Typical Antipsychotic [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Haloperidol
Listing expiration
2026-12-31

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
0143-9319-25Haloperidol1 mL in 1 VIALINJECTION14
0143-9319-25Haloperidol25 in 1 BOXINJECTION254

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0143-9319-25ML - Milliliter0143-93199ebf30f1-bc43-4c04-924c-9c81036240cb12018-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0143-9319HALOPERIDOL (HALOPERIDOL LACTATE) INJECTION [HIKMA PHARMACEUTICALS USA INC.]4Current NDC, Legacy NDC, 2 package rows20220727_ec7a3560-71c3-43f5-bc6c-d51eadfd2aa1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1719646haloperidol 5 MG in 1 ML InjectionPSNec7a3560-71c3-43f5-bc6c-d51eadfd2aa14
17196461 ML haloperidol 5 MG/ML InjectionSCDec7a3560-71c3-43f5-bc6c-d51eadfd2aa14
1719646haloperidol (as haloperidol lactate) 5 MG per 1 ML InjectionSYec7a3560-71c3-43f5-bc6c-d51eadfd2aa14

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0143-9319-250014393192525 VIAL in 1 BOX (0143-9319-25) / 1 mL in 1 VIAL25 vial2018-09-140000-00-00NoNoCurrent