FDA.reportPublic FDA data

Haldol Decanoate

Product NDC
50458-254
11-digit product format
504580254
Labeler code
50458
Product ID
50458-254_43588a6b-8b38-dcaa-e063-6294a90a1666
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Haloperidol Decanoate
Dosage form
INJECTION
Route
INTRAMUSCULAR
Labeler
Janssen Pharmaceuticals, Inc.
Application
NDA018701
Marketing category
NDA
Marketing start
1986-01-14
Marketing end
2027-08-31
Substance
HALOPERIDOL DECANOATE
Active strength
100 mg/mL
Pharmacologic classes
Typical Antipsychotic [EPC]
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Haldol Decanoate

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HALOPERIDOL DECANOATE100 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiAC20PJ4101
Rxcui1719803, 1719847, 1719862, 1720026

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
50458-254-14Haldol Decanoate5 in 1 BOXINJECTION525
50458-254-14Haldol Decanoate1 mL in 1 AMPULEINJECTION125

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50458-254-14ML - Milliliter50458-254f851ac18-f8ff-44f0-9904-f0804b05a1b912012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Haloperidol DecanoateACTIVE INGREDIENTAC20PJ4101HALDOL DECANOATE (HALOPERIDOL DECANOATE) INJECTION [JANSSEN PHARMACEUTICALS, INC.]10
HaloperidolACTIVE MOIETYJ6292F8L3DHALDOL DECANOATE (HALOPERIDOL DECANOATE) INJECTION [JANSSEN PHARMACEUTICALS, INC.]10
benzyl alcoholINACTIVE INGREDIENTLKG8494WBHHALDOL DECANOATE (HALOPERIDOL DECANOATE) INJECTION [JANSSEN PHARMACEUTICALS, INC.]10
sesame oilINACTIVE INGREDIENTQX10HYY4QVHALDOL DECANOATE (HALOPERIDOL DECANOATE) INJECTION [JANSSEN PHARMACEUTICALS, INC.]10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50458-254HALDOL DECANOATE (HALOPERIDOL DECANOATE) INJECTION [JANSSEN PHARMACEUTICALS, INC.]24Current NDC, Legacy NDC, 2 package rows20250131_af0159a8-dff5-449a-aa2b-a0c430081e21.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1719847Haldol Decanoate 100 MG in 1 ML InjectionPSNaf0159a8-dff5-449a-aa2b-a0c430081e2125
1720026Haldol Decanoate 50 MG in 1 ML InjectionPSNaf0159a8-dff5-449a-aa2b-a0c430081e2125
1719803haloperidol decanoate 100 MG in 1 ML InjectionPSNaf0159a8-dff5-449a-aa2b-a0c430081e2125
1719862haloperidol decanoate 50 MG in 1 ML InjectionPSNaf0159a8-dff5-449a-aa2b-a0c430081e2125
17198471 ML haloperidol decanoate 100 MG/ML Injection [Haldol]SBDaf0159a8-dff5-449a-aa2b-a0c430081e2125
17200261 ML haloperidol decanoate 50 MG/ML Injection [Haldol]SBDaf0159a8-dff5-449a-aa2b-a0c430081e2125
17198031 ML haloperidol decanoate 100 MG/ML InjectionSCDaf0159a8-dff5-449a-aa2b-a0c430081e2125
17198621 ML haloperidol decanoate 50 MG/ML InjectionSCDaf0159a8-dff5-449a-aa2b-a0c430081e2125
17198471 ML Haldol 100 MG/ML InjectionSYaf0159a8-dff5-449a-aa2b-a0c430081e2125
17200261 ML Haldol 50 MG/ML InjectionSYaf0159a8-dff5-449a-aa2b-a0c430081e2125
1719847Haldol Decanoate 100 MG per 1 ML InjectionSYaf0159a8-dff5-449a-aa2b-a0c430081e2125
1720026Haldol Decanoate 50 MG per 1 ML InjectionSYaf0159a8-dff5-449a-aa2b-a0c430081e2125
1719803haloperidol decanoate 100 MG per 1 ML InjectionSYaf0159a8-dff5-449a-aa2b-a0c430081e2125
1719862haloperidol decanoate 50 MG per 1 ML InjectionSYaf0159a8-dff5-449a-aa2b-a0c430081e2125

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50458-254-14504580254145 AMPULE in 1 BOX (50458-254-14) / 1 mL in 1 AMPULE5 ampule1986-01-142027-08-31NoNoCurrent