Haloperidol Decanoate

Product NDC
67457-409
11-digit product format
674570409
Labeler code
67457
Product ID
67457-409_59ec8e4f-5adc-4342-add6-1357f5512cbd
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
Substance
HALOPERIDOL DECANOATE
Active strength
100 mg/mL
Pharmacologic classes
Typical Antipsychotic [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Haloperidol Decanoate
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HALOPERIDOL DECANOATE100 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiAC20PJ4101
Rxcui1719803, 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
67457-409-00Haloperidol Decanoate1 mL in 1 VIALINJECTION19
67457-409-13Haloperidol Decanoate5 in 1 CARTONINJECTION59

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
67457-409-00ML - Milliliter67457-40988e642e2-74f0-4b29-a10f-88ec4d70a3e912014-10-03
67457-409-13ML - Milliliter67457-409dfa5ee19-60a6-45a1-9140-09596fa03c5712014-10-03

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
67457-409HALOPERIDOL DECANOATE INJECTION [MYLAN INSTITUTIONAL LLC]8Current NDC, Legacy NDC, 2 package rows20250226_8ffac6fb-1702-40d6-b085-152d24673cbd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1719803haloperidol decanoate 100 MG in 1 ML InjectionPSN8ffac6fb-1702-40d6-b085-152d24673cbd9
1719862haloperidol decanoate 50 MG in 1 ML InjectionPSN8ffac6fb-1702-40d6-b085-152d24673cbd9
17198031 ML haloperidol decanoate 100 MG/ML InjectionSCD8ffac6fb-1702-40d6-b085-152d24673cbd9
17198621 ML haloperidol decanoate 50 MG/ML InjectionSCD8ffac6fb-1702-40d6-b085-152d24673cbd9
1719803haloperidol decanoate 100 MG per 1 ML InjectionSY8ffac6fb-1702-40d6-b085-152d24673cbd9
1719862haloperidol decanoate 50 MG per 1 ML InjectionSY8ffac6fb-1702-40d6-b085-152d24673cbd9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67457-409-00674570409001 mL in 1 VIAL1 mlHistorical
67457-409-13674570409135 VIAL in 1 CARTON (67457-409-13) / 1 mL in 1 VIAL (67457-409-00) 5 vial2014-03-010000-00-00NoNoCurrent