Haloperidol Decanoate

Product NDC
0143-9295
11-digit product format
001439295
Labeler code
0143
Product ID
0143-9295_4d57ff6f-2f61-49f5-95d7-cbfa3505f020
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Haloperidol Decanoate
Dosage form
INJECTION
Route
INTRAMUSCULAR
Labeler
Hikma Pharmaceuticals USA Inc.
Application
ANDA075305
Marketing category
ANDA
Marketing start
1998-10-01
Substance
HALOPERIDOL DECANOATE
Active strength
100 mg/mL
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 Decanoate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HALOPERIDOL DECANOATE100 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiAC20PJ4101
Rxcui859871, 1719803

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
0143-9295-01Haloperidol Decanoate1 mL in 1 VIALINJECTION16
0143-9295-01Haloperidol Decanoate1 in 1 BOXINJECTION16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0143-9295-01ML - Milliliter0143-9295403a4788-fc84-49b7-9961-4e9279dc4b4b12020-01-03

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0143-9295HALOPERIDOL DECANOATE INJECTION [HIKMA PHARMACEUTICALS USA INC.]6Current NDC, Legacy NDC, 2 package rows20250312_914026da-103a-4466-abd5-3763e9d55b67.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1719803haloperidol decanoate 100 MG in 1 ML InjectionPSN914026da-103a-4466-abd5-3763e9d55b676
859871haloperidol decanoate 100 MG/ML Injectable SolutionPSN914026da-103a-4466-abd5-3763e9d55b676
17198031 ML haloperidol decanoate 100 MG/ML InjectionSCD914026da-103a-4466-abd5-3763e9d55b676
859871haloperidol decanoate 100 MG/ML Injectable SolutionSCD914026da-103a-4466-abd5-3763e9d55b676
859871haloperidol 100 MG/ML (as haloperidol decanoate) Injectable SolutionSY914026da-103a-4466-abd5-3763e9d55b676
1719803haloperidol decanoate 100 MG per 1 ML InjectionSY914026da-103a-4466-abd5-3763e9d55b676

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0143-9295-01001439295011 VIAL in 1 BOX (0143-9295-01) / 1 mL in 1 VIAL1 vial1998-10-010000-00-00NoNoCurrent