Haloperidol

Product NDC
0615-8626
11-digit product format
006158626
Labeler code
0615
Product ID
0615-8626_21b9d026-f029-427f-aa44-1e3f82f5a185
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
haloperidol
Dosage form
TABLET
Route
ORAL
Labeler
NCS HealthCare of KY, LLC dba Vangard Labs
Application
ANDA216918
Marketing category
ANDA
Marketing start
2024-04-11
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
HALOPERIDOL5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiJ6292F8L3D
Rxcui310672, 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
0615-8626-39Haloperidol30 in 1 BLISTER PACKTABLET302

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314035haloperidol 10 MG Oral TabletPSN8743da03-67f1-4cb0-8159-45141cb5466e2
310672haloperidol 5 MG Oral TabletPSN8743da03-67f1-4cb0-8159-45141cb5466e2
314035haloperidol 10 MG Oral TabletSCD8743da03-67f1-4cb0-8159-45141cb5466e2
310672haloperidol 5 MG Oral TabletSCD8743da03-67f1-4cb0-8159-45141cb5466e2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0615-8626-390061586263930 TABLET in 1 BLISTER PACK (0615-8626-39) 30 tablet2026-04-02NoNoCurrent