FDA.reportPublic FDA data

haloperidol decanoate

Product NDC
25021-834
11-digit product format
250210834
Labeler code
25021
Product ID
25021-834_62e2ca03-9545-4170-a750-d457aa2451a9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
haloperidol decanoate
Dosage form
INJECTION, SOLUTION
Route
INTRAMUSCULAR
Labeler
Sagent Pharmaceuticals
Application
ANDA205241
Marketing category
ANDA
Marketing start
2017-11-15
Substance
HALOPERIDOL DECANOATE
Active strength
500 mg/5mL
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 DECANOATE500 mg/5mL

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
25021-834-05haloperidol decanoate1 in 1 CARTONINJECTION, SOLUTION15
25021-834-05haloperidol decanoate5 mL in 1 VIALINJECTION, SOLUTION55

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
25021-834-05ML - Milliliter25021-834951617ea-2d73-4cde-927f-eb6ba1f79cbd12018-01-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
25021-834HALOPERIDOL DECANOATE INJECTION, SOLUTION [SAGENT PHARMACEUTICALS]5Current NDC, Legacy NDC, 2 package rows20240507_b3167043-585f-482f-b8a7-591bc2721bd3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1719803haloperidol decanoate 100 MG in 1 ML InjectionPSNb3167043-585f-482f-b8a7-591bc2721bd35
859871haloperidol decanoate 100 MG/ML Injectable SolutionPSNb3167043-585f-482f-b8a7-591bc2721bd35
1719862haloperidol decanoate 50 MG in 1 ML InjectionPSNb3167043-585f-482f-b8a7-591bc2721bd35
17198031 ML haloperidol decanoate 100 MG/ML InjectionSCDb3167043-585f-482f-b8a7-591bc2721bd35
17198621 ML haloperidol decanoate 50 MG/ML InjectionSCDb3167043-585f-482f-b8a7-591bc2721bd35
859871haloperidol decanoate 100 MG/ML Injectable SolutionSCDb3167043-585f-482f-b8a7-591bc2721bd35
859871haloperidol 100 MG/ML (as haloperidol decanoate) Injectable SolutionSYb3167043-585f-482f-b8a7-591bc2721bd35
1719803haloperidol decanoate 100 MG per 1 ML InjectionSYb3167043-585f-482f-b8a7-591bc2721bd35
1719862haloperidol decanoate 50 MG per 1 ML InjectionSYb3167043-585f-482f-b8a7-591bc2721bd35

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
25021-834-05250210834051 VIAL in 1 CARTON (25021-834-05) / 5 mL in 1 VIAL1 vial2017-11-150000-00-00NoNoCurrent