Haloperidol Decanoate

Product NDC
67457-381
11-digit product format
674570381
Labeler code
67457
Product ID
67457-381_c0d3dc0a-61bd-40ee-87b1-1d4ae489cd52
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Haloperidol Decanoate
Dosage form
INJECTION
Route
INTRAMUSCULAR
Labeler
Mylan Institutional LLC
Application
ANDA075440
Marketing category
ANDA
Marketing start
2014-03-01
Marketing end
2023-01-31
Substance
HALOPERIDOL DECANOATE
Active strength
100 mg/mL
Pharmacologic classes
Typical Antipsychotic [EPC]
NDC exclude flag
No
Listing certified through
0000-00-00
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
67457-381-00ML - Milliliter67457-3811d48d724-59f2-4ccc-82e2-7239d9e0bb0912014-08-01
67457-381-58ML - Milliliter67457-381948610ea-b3b0-4995-8535-4a18bdf5df3d12014-08-01

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
HALOPERIDOL DECANOATEACTIVE INGREDIENTAC20PJ4101HALOPERIDOL DECANOATE INJECTION [MYLAN INSTITUTIONAL LLC ]2
HALOPERIDOLACTIVE MOIETYJ6292F8L3DHALOPERIDOL DECANOATE INJECTION [MYLAN INSTITUTIONAL LLC ]2
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBHHALOPERIDOL DECANOATE INJECTION [MYLAN INSTITUTIONAL LLC ]2
SESAME OILINACTIVE INGREDIENTQX10HYY4QVHALOPERIDOL DECANOATE INJECTION [MYLAN INSTITUTIONAL LLC ]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67457-381HALOPERIDOL DECANOATE INJECTION [MYLAN INSTITUTIONAL LLC]8Legacy NDC20250226_8ffac6fb-1702-40d6-b085-152d24673cbd.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67457-381-58674570381585 VIAL in 1 CARTON (67457-381-58) > 5 mL in 1 VIAL (67457-381-00) 5 vial2014-03-010000-00-00NoNoCurrent