FDA.reportPublic FDA data

Haloperidol Decanoate

Product NDC
63323-469
11-digit product format
633230469
Labeler code
63323
Product ID
63323-469_86dff2aa-2ab3-42fc-989e-619b13ace573
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
HALOPERIDOL DECANOATE
Dosage form
INJECTION
Route
INTRAMUSCULAR
Labeler
Fresenius Kabi USA, LLC
Application
ANDA074893
Marketing category
ANDA
Marketing start
2000-02-16
Substance
HALOPERIDOL DECANOATE
Active strength
50 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 DECANOATE50 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiAC20PJ4101
Rxcui859867, 859871, 1719803, 1719862

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
63323-469-01Haloperidol Decanoate1 mL in 1 VIALINJECTION19
63323-469-01Haloperidol Decanoate1 in 1 CARTONINJECTION19
63323-469-05Haloperidol Decanoate5 mL in 1 VIAL, MULTI-DOSEINJECTION59
63323-469-05Haloperidol Decanoate1 in 1 CARTONINJECTION19

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63323-469-01ML - Milliliter63323-469d672e0c4-0f96-415b-9a59-86359a6d3ebf12012-07-24
63323-469-05ML - Milliliter63323-469f0a706c6-35eb-4456-93c0-bb5d1e1c42e512012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
HALOPERIDOL DECANOATEACTIVE INGREDIENTAC20PJ4101HALOPERIDOL DECANOATE INJECTION [FRESENIUS KABI USA, LLC]5
HALOPERIDOLACTIVE MOIETYJ6292F8L3DHALOPERIDOL DECANOATE INJECTION [FRESENIUS KABI USA, LLC]5
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBHHALOPERIDOL DECANOATE INJECTION [FRESENIUS KABI USA, LLC]5
SESAME OILINACTIVE INGREDIENTQX10HYY4QVHALOPERIDOL DECANOATE INJECTION [FRESENIUS KABI USA, LLC]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63323-469HALOPERIDOL DECANOATE INJECTION [FRESENIUS KABI USA, LLC ]9Current NDC, Legacy NDC, 4 package rows20211106_ca9896e0-fb2e-46a4-8700-20d144c14764.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1719803haloperidol decanoate 100 MG in 1 ML InjectionPSNca9896e0-fb2e-46a4-8700-20d144c147649
859871haloperidol decanoate 100 MG/ML Injectable SolutionPSNca9896e0-fb2e-46a4-8700-20d144c147649
1719862haloperidol decanoate 50 MG in 1 ML InjectionPSNca9896e0-fb2e-46a4-8700-20d144c147649
859867haloperidol decanoate 50 MG/ML Injectable SolutionPSNca9896e0-fb2e-46a4-8700-20d144c147649
17198031 ML haloperidol decanoate 100 MG/ML InjectionSCDca9896e0-fb2e-46a4-8700-20d144c147649
17198621 ML haloperidol decanoate 50 MG/ML InjectionSCDca9896e0-fb2e-46a4-8700-20d144c147649
859871haloperidol decanoate 100 MG/ML Injectable SolutionSCDca9896e0-fb2e-46a4-8700-20d144c147649
859867haloperidol decanoate 50 MG/ML Injectable SolutionSCDca9896e0-fb2e-46a4-8700-20d144c147649
859871haloperidol 100 MG/ML (as haloperidol decanoate) Injectable SolutionSYca9896e0-fb2e-46a4-8700-20d144c147649
859867haloperidol 50 MG/ML (as haloperidol decanoate) Injectable SolutionSYca9896e0-fb2e-46a4-8700-20d144c147649
1719803haloperidol decanoate 100 MG per 1 ML InjectionSYca9896e0-fb2e-46a4-8700-20d144c147649
1719862haloperidol decanoate 50 MG per 1 ML InjectionSYca9896e0-fb2e-46a4-8700-20d144c147649

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63323-469-01633230469011 VIAL in 1 CARTON (63323-469-01) / 1 mL in 1 VIAL1 vial2000-02-160000-00-00NoNoCurrent
63323-469-05633230469051 VIAL, MULTI-DOSE in 1 CARTON (63323-469-05) / 5 mL in 1 VIAL, MULTI-DOSE2000-02-160000-00-00NoNoCurrent