Haloperidol Decanoate

Product NDC
70756-615
11-digit product format
707560615
Labeler code
70756
Product ID
70756-615_bae2fb28-774a-44e2-89ed-4412e71f98ec
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Haloperidol Decanoate
Dosage form
INJECTION
Route
INTRAMUSCULAR
Labeler
Lifestar Pharma LLC
Application
ANDA216730
Marketing category
ANDA
Marketing start
2023-05-23
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
70756-615-10Haloperidol Decanoate10 in 1 CARTONINJECTION107
70756-615-10Haloperidol Decanoate1 mL in 1 VIALINJECTION17
70756-615-33Haloperidol Decanoate3 in 1 CARTONINJECTION37
70756-615-33Haloperidol Decanoate1 mL in 1 VIALINJECTION17
70756-615-81Haloperidol Decanoate1 in 1 CARTONINJECTION17
70756-615-81Haloperidol Decanoate1 mL in 1 VIALINJECTION17

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70756-615HALOPERIDOL DECANOATE INJECTION [LIFESTAR PHARMA LLC]6Current NDC, 6 package rows20250228_8a96195e-97cd-4161-96e0-494a1636fa9c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1719803haloperidol decanoate 100 MG in 1 ML InjectionPSN8a96195e-97cd-4161-96e0-494a1636fa9c7
859871haloperidol decanoate 100 MG/ML Injectable SolutionPSN8a96195e-97cd-4161-96e0-494a1636fa9c7
1719862haloperidol decanoate 50 MG in 1 ML InjectionPSN8a96195e-97cd-4161-96e0-494a1636fa9c7
859867haloperidol decanoate 50 MG/ML Injectable SolutionPSN8a96195e-97cd-4161-96e0-494a1636fa9c7
17198031 ML haloperidol decanoate 100 MG/ML InjectionSCD8a96195e-97cd-4161-96e0-494a1636fa9c7
17198621 ML haloperidol decanoate 50 MG/ML InjectionSCD8a96195e-97cd-4161-96e0-494a1636fa9c7
859871haloperidol decanoate 100 MG/ML Injectable SolutionSCD8a96195e-97cd-4161-96e0-494a1636fa9c7
859867haloperidol decanoate 50 MG/ML Injectable SolutionSCD8a96195e-97cd-4161-96e0-494a1636fa9c7
859871haloperidol 100 MG/ML (as haloperidol decanoate) Injectable SolutionSY8a96195e-97cd-4161-96e0-494a1636fa9c7
859867haloperidol 50 MG/ML (as haloperidol decanoate) Injectable SolutionSY8a96195e-97cd-4161-96e0-494a1636fa9c7
1719803haloperidol decanoate 100 MG per 1 ML InjectionSY8a96195e-97cd-4161-96e0-494a1636fa9c7
1719862haloperidol decanoate 50 MG per 1 ML InjectionSY8a96195e-97cd-4161-96e0-494a1636fa9c7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70756-615-107075606151010 VIAL in 1 CARTON (70756-615-10) / 1 mL in 1 VIAL10 vial2023-05-23NoNoCurrent
70756-615-33707560615333 VIAL in 1 CARTON (70756-615-33) / 1 mL in 1 VIAL3 vial2023-05-23NoNoCurrent
70756-615-81707560615811 VIAL in 1 CARTON (70756-615-81) / 1 mL in 1 VIAL1 vial2023-05-23NoNoCurrent