Haloperidol

Product NDC
0904-7391
11-digit product format
009047391
Labeler code
0904
Product ID
0904-7391_5cdf5cc5-d403-44de-84bd-b94363e8bd60
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Haloperidol
Dosage form
TABLET
Route
ORAL
Labeler
Major Pharmaceuticals
Application
ANDA071173
Marketing category
ANDA
Marketing start
2023-07-18
Marketing end
2026-06-30
Substance
HALOPERIDOL
Active strength
2 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
HALOPERIDOL2 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiJ6292F8L3D
Rxcui310670, 310671, 314034

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
0904-7391-61Haloperidol100 in 1 CARTONTABLET1004
0904-7391-61Haloperidol1 in 1 BLISTER PACKTABLET14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0904-7391HALOPERIDOL TABLET [MAJOR PHARMACEUTICALS]3Current NDC, 2 package rows20250321_f5bfb3b9-0c6d-4f04-8bfc-d063cd8bb8ed.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310670haloperidol 0.5 MG Oral TabletPSNf5bfb3b9-0c6d-4f04-8bfc-d063cd8bb8ed4
310671haloperidol 1 MG Oral TabletPSNf5bfb3b9-0c6d-4f04-8bfc-d063cd8bb8ed4
314034haloperidol 2 MG Oral TabletPSNf5bfb3b9-0c6d-4f04-8bfc-d063cd8bb8ed4
310670haloperidol 0.5 MG Oral TabletSCDf5bfb3b9-0c6d-4f04-8bfc-d063cd8bb8ed4
310671haloperidol 1 MG Oral TabletSCDf5bfb3b9-0c6d-4f04-8bfc-d063cd8bb8ed4
314034haloperidol 2 MG Oral TabletSCDf5bfb3b9-0c6d-4f04-8bfc-d063cd8bb8ed4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0904-7391-6100904739161100 BLISTER PACK in 1 CARTON (0904-7391-61) / 1 TABLET in 1 BLISTER PACK100 blister pack2023-07-182026-06-30NoNoHistorical