FDA.reportPublic FDA data

Haloperidol

Product NDC
0378-0351
11-digit product format
003780351
Labeler code
0378
Product ID
0378-0351_1b33ae94-4fa5-4298-a713-3e049c47588c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
haloperidol
Dosage form
TABLET
Route
ORAL
Labeler
Mylan Pharmaceuticals Inc.
Application
ANDA070278
Marketing category
ANDA
Marketing start
1986-06-10
Marketing end
2027-05-31
Substance
HALOPERIDOL
Active strength
.5 mg/1
Pharmacologic classes
Typical Antipsychotic [EPC]
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Haloperidol

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HALOPERIDOL.5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiJ6292F8L3D
Rxcui197754, 310670, 310671, 310672, 314034, 314035

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
ce329990-eb12-45a5-87d5-ce5ef054ca71Product name220190930

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0378-0351-01Haloperidol100 in 1 BOTTLE, PLASTICTABLET10022
0378-0351-10Haloperidol1000 in 1 BOTTLE, PLASTICTABLET100022

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0378-0351HALOPERIDOL TABLET [MYLAN PHARMACEUTICALS INC.]21Current NDC, Legacy NDC, 2 package rows20250326_c559b0b0-4087-d12a-e718-c18ccb6811e6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310670haloperidol 0.5 MG Oral TabletPSNc559b0b0-4087-d12a-e718-c18ccb6811e622
310671haloperidol 1 MG Oral TabletPSNc559b0b0-4087-d12a-e718-c18ccb6811e622
314035haloperidol 10 MG Oral TabletPSNc559b0b0-4087-d12a-e718-c18ccb6811e622
314034haloperidol 2 MG Oral TabletPSNc559b0b0-4087-d12a-e718-c18ccb6811e622
197754haloperidol 20 MG Oral TabletPSNc559b0b0-4087-d12a-e718-c18ccb6811e622
310672haloperidol 5 MG Oral TabletPSNc559b0b0-4087-d12a-e718-c18ccb6811e622
310670haloperidol 0.5 MG Oral TabletSCDc559b0b0-4087-d12a-e718-c18ccb6811e622
310671haloperidol 1 MG Oral TabletSCDc559b0b0-4087-d12a-e718-c18ccb6811e622
314035haloperidol 10 MG Oral TabletSCDc559b0b0-4087-d12a-e718-c18ccb6811e622
314034haloperidol 2 MG Oral TabletSCDc559b0b0-4087-d12a-e718-c18ccb6811e622
197754haloperidol 20 MG Oral TabletSCDc559b0b0-4087-d12a-e718-c18ccb6811e622
310672haloperidol 5 MG Oral TabletSCDc559b0b0-4087-d12a-e718-c18ccb6811e622
310670haloperidol 0.5 MG Oral TabletPSNad7d2f17-a4e8-4ebc-9baf-5983ac62678218
310671haloperidol 1 MG Oral TabletPSNad7d2f17-a4e8-4ebc-9baf-5983ac62678218
314035haloperidol 10 MG Oral TabletPSNad7d2f17-a4e8-4ebc-9baf-5983ac62678218
314034haloperidol 2 MG Oral TabletPSNad7d2f17-a4e8-4ebc-9baf-5983ac62678218
310672haloperidol 5 MG Oral TabletPSNad7d2f17-a4e8-4ebc-9baf-5983ac62678218
310670haloperidol 0.5 MG Oral TabletSCDad7d2f17-a4e8-4ebc-9baf-5983ac62678218
310671haloperidol 1 MG Oral TabletSCDad7d2f17-a4e8-4ebc-9baf-5983ac62678218
314035haloperidol 10 MG Oral TabletSCDad7d2f17-a4e8-4ebc-9baf-5983ac62678218
314034haloperidol 2 MG Oral TabletSCDad7d2f17-a4e8-4ebc-9baf-5983ac62678218
310672haloperidol 5 MG Oral TabletSCDad7d2f17-a4e8-4ebc-9baf-5983ac62678218
310670haloperidol 0.5 MG Oral TabletPSN59903eb9-77a2-42b3-ae09-af94ac209d324
310671haloperidol 1 MG Oral TabletPSN59903eb9-77a2-42b3-ae09-af94ac209d324
314035haloperidol 10 MG Oral TabletPSN59903eb9-77a2-42b3-ae09-af94ac209d324
314034haloperidol 2 MG Oral TabletPSN59903eb9-77a2-42b3-ae09-af94ac209d324
197754haloperidol 20 MG Oral TabletPSN59903eb9-77a2-42b3-ae09-af94ac209d324
310672haloperidol 5 MG Oral TabletPSN59903eb9-77a2-42b3-ae09-af94ac209d324
310670haloperidol 0.5 MG Oral TabletSCD59903eb9-77a2-42b3-ae09-af94ac209d324
310671haloperidol 1 MG Oral TabletSCD59903eb9-77a2-42b3-ae09-af94ac209d324
314035haloperidol 10 MG Oral TabletSCD59903eb9-77a2-42b3-ae09-af94ac209d324
314034haloperidol 2 MG Oral TabletSCD59903eb9-77a2-42b3-ae09-af94ac209d324
197754haloperidol 20 MG Oral TabletSCD59903eb9-77a2-42b3-ae09-af94ac209d324
310672haloperidol 5 MG Oral TabletSCD59903eb9-77a2-42b3-ae09-af94ac209d324
310670haloperidol 0.5 MG Oral TabletPSN2ccc2e26-de98-af81-e063-6394a90a040b1
310670haloperidol 0.5 MG Oral TabletSCD2ccc2e26-de98-af81-e063-6394a90a040b1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0378-0351-0100378035101100 TABLET in 1 BOTTLE, PLASTIC (0378-0351-01) 100 tablet1986-06-102027-05-31NoNoCurrent
0378-0351-10003780351101000 TABLET in 1 BOTTLE, PLASTIC (0378-0351-10) 1000 tablet1986-06-102027-05-31NoNoCurrent