FDA.reportPublic FDA data

HALOPERIDOL

Product NDC
72205-064
11-digit product format
722050064
Labeler code
72205
Product ID
72205-064_6d0f349d-2354-4358-8fa2-5e35da47eb00
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
HALOPERIDOL
Dosage form
TABLET
Route
ORAL
Labeler
Novadoz Pharmaceuticals LLC
Application
ANDA216004
Marketing category
ANDA
Marketing start
2022-11-18
Substance
HALOPERIDOL
Active strength
.5 mg/1
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
Listing expiration
2027-12-31

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
72205-064-91HALOPERIDOL100 in 1 BOTTLETABLET1003
72205-064-99HALOPERIDOL1000 in 1 BOTTLETABLET10003

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72205-064HALOPERIDOL TABLET [NOVADOZ PHARMACEUTICALS LLC]2Current NDC, Legacy NDC, 2 package rows20250322_3a474e06-fb00-40cb-aa3a-6edad43c2c0a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310670haloperidol 0.5 MG Oral TabletPSN3a474e06-fb00-40cb-aa3a-6edad43c2c0a3
310671haloperidol 1 MG Oral TabletPSN3a474e06-fb00-40cb-aa3a-6edad43c2c0a3
314035haloperidol 10 MG Oral TabletPSN3a474e06-fb00-40cb-aa3a-6edad43c2c0a3
314034haloperidol 2 MG Oral TabletPSN3a474e06-fb00-40cb-aa3a-6edad43c2c0a3
197754haloperidol 20 MG Oral TabletPSN3a474e06-fb00-40cb-aa3a-6edad43c2c0a3
310672haloperidol 5 MG Oral TabletPSN3a474e06-fb00-40cb-aa3a-6edad43c2c0a3
310670haloperidol 0.5 MG Oral TabletSCD3a474e06-fb00-40cb-aa3a-6edad43c2c0a3
310671haloperidol 1 MG Oral TabletSCD3a474e06-fb00-40cb-aa3a-6edad43c2c0a3
314035haloperidol 10 MG Oral TabletSCD3a474e06-fb00-40cb-aa3a-6edad43c2c0a3
314034haloperidol 2 MG Oral TabletSCD3a474e06-fb00-40cb-aa3a-6edad43c2c0a3
197754haloperidol 20 MG Oral TabletSCD3a474e06-fb00-40cb-aa3a-6edad43c2c0a3
310672haloperidol 5 MG Oral TabletSCD3a474e06-fb00-40cb-aa3a-6edad43c2c0a3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72205-064-9172205006491100 TABLET in 1 BOTTLE (72205-064-91) 100 tablet2022-11-220000-00-00NoNoCurrent
72205-064-99722050064991000 TABLET in 1 BOTTLE (72205-064-99) 1000 tablet2022-11-220000-00-00NoNoCurrent