FDA.reportPublic FDA data

Haloperidol Decanoate

Product NDC
65145-168
11-digit product format
651450168
Labeler code
65145
Product ID
65145-168_4f9af14a-38c4-4826-aca0-3501edb854e3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Haloperidol Decanoate
Dosage form
INJECTION
Route
INTRAMUSCULAR
Labeler
Caplin Steriles Limited
Application
ANDA219168
Marketing category
ANDA
Marketing start
2025-05-26
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
Rxcui859871, 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
65145-168-01Haloperidol Decanoate1 mL in 1 VIAL, SINGLE-DOSEINJECTION11
65145-168-10Haloperidol Decanoate10 in 1 CARTONINJECTION101

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65145-168-01ML - Milliliter65145-1685f85c8e7-c628-4c92-82da-f99c67ce554312026-02-05
65145-168-10ML - Milliliter65145-168ecf3f6a2-22d0-43a6-9301-4efefb4e314c12026-02-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65145-168HALOPERIDOL DECANOATE INJECTION [CAPLIN STERILES LIMITED]1Current NDC, 2 package rows20250528_4f9af14a-38c4-4826-aca0-3501edb854e3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1719803haloperidol decanoate 100 MG in 1 ML InjectionPSN4f9af14a-38c4-4826-aca0-3501edb854e31
859871haloperidol decanoate 100 MG/ML Injectable SolutionPSN4f9af14a-38c4-4826-aca0-3501edb854e31
1719862haloperidol decanoate 50 MG in 1 ML InjectionPSN4f9af14a-38c4-4826-aca0-3501edb854e31
17198031 ML haloperidol decanoate 100 MG/ML InjectionSCD4f9af14a-38c4-4826-aca0-3501edb854e31
17198621 ML haloperidol decanoate 50 MG/ML InjectionSCD4f9af14a-38c4-4826-aca0-3501edb854e31
859871haloperidol decanoate 100 MG/ML Injectable SolutionSCD4f9af14a-38c4-4826-aca0-3501edb854e31
859871haloperidol 100 MG/ML (as haloperidol decanoate) Injectable SolutionSY4f9af14a-38c4-4826-aca0-3501edb854e31
1719803haloperidol decanoate 100 MG per 1 ML InjectionSY4f9af14a-38c4-4826-aca0-3501edb854e31
1719862haloperidol decanoate 50 MG per 1 ML InjectionSY4f9af14a-38c4-4826-aca0-3501edb854e31

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
65145-168-01651450168011 mL in 1 VIAL, SINGLE-DOSE1 mlHistorical
65145-168-106514501681010 VIAL, SINGLE-DOSE in 1 CARTON (65145-168-10) / 1 mL in 1 VIAL, SINGLE-DOSE (65145-168-01) 2025-05-26NoNoCurrent