Haloperidol

Product NDC
59651-792
11-digit product format
596510792
Labeler code
59651
Product ID
59651-792_265a70c4-9b29-464c-9258-735bd2b2ccf7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Haloperidol
Dosage form
TABLET
Route
ORAL
Labeler
Aurobindo Pharma Limited
Application
ANDA218789
Marketing category
ANDA
Marketing start
2024-04-19
Substance
HALOPERIDOL
Active strength
5 mg/1
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
HALOPERIDOL5 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
59651-792-01Haloperidol100 in 1 BOTTLETABLET1003
59651-792-99Haloperidol1000 in 1 BOTTLETABLET10003

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59651-792-01EA - Each59651-792e492c4d2-87ea-4f9c-8a71-e82974b9e20912024-09-09
59651-792-99EA - Each59651-79259626177-2171-401d-9fe4-076109e5adf712024-09-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59651-792HALOPERIDOL TABLET [AUROBINDO PHARMA LIMITED]3Current NDC, 2 package rows20241121_bf21633e-f37b-4017-a143-538eb005de2d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310670haloperidol 0.5 MG Oral TabletPSNbf21633e-f37b-4017-a143-538eb005de2d3
310671haloperidol 1 MG Oral TabletPSNbf21633e-f37b-4017-a143-538eb005de2d3
314035haloperidol 10 MG Oral TabletPSNbf21633e-f37b-4017-a143-538eb005de2d3
314034haloperidol 2 MG Oral TabletPSNbf21633e-f37b-4017-a143-538eb005de2d3
197754haloperidol 20 MG Oral TabletPSNbf21633e-f37b-4017-a143-538eb005de2d3
310672haloperidol 5 MG Oral TabletPSNbf21633e-f37b-4017-a143-538eb005de2d3
310670haloperidol 0.5 MG Oral TabletSCDbf21633e-f37b-4017-a143-538eb005de2d3
310671haloperidol 1 MG Oral TabletSCDbf21633e-f37b-4017-a143-538eb005de2d3
314035haloperidol 10 MG Oral TabletSCDbf21633e-f37b-4017-a143-538eb005de2d3
314034haloperidol 2 MG Oral TabletSCDbf21633e-f37b-4017-a143-538eb005de2d3
197754haloperidol 20 MG Oral TabletSCDbf21633e-f37b-4017-a143-538eb005de2d3
310672haloperidol 5 MG Oral TabletSCDbf21633e-f37b-4017-a143-538eb005de2d3
310672haloperidol 5 MG Oral TabletPSN40187e83-1144-db0e-e063-6394a90a42df1
310672haloperidol 5 MG Oral TabletSCD40187e83-1144-db0e-e063-6394a90a42df1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
59651-792-0159651079201100 TABLET in 1 BOTTLE (59651-792-01) 100 tablet2024-04-19NoNoHistorical
59651-792-99596510792991000 TABLET in 1 BOTTLE (59651-792-99) 1000 tablet2024-04-19NoNoHistorical