Haloperidol

Product NDC
67046-0053
11-digit product format
670460053
Labeler code
67046
Product ID
67046-0053_38f58246-c2e2-01f8-e063-6394a90a3b7d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Haloperidol
Dosage form
TABLET
Route
ORAL
Labeler
Coupler LLC
Application
ANDA071173
Marketing category
ANDA
Marketing start
2025-07-02
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
Rxcui310672

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
67046-0053-3Haloperidol30 in 1 BLISTER PACKTABLET301

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310672haloperidol 5 MG Oral TabletPSN38f59751-4741-f588-e063-6294a90a65281
310672haloperidol 5 MG Oral TabletSCD38f59751-4741-f588-e063-6294a90a65281

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
67046-0053-36704600530330 TABLET in 1 BLISTER PACK (67046-0053-3) 30 tablet2025-07-02NoNoCurrent