FDA.reportPublic FDA data

Haloperidol Decanoate

Product NDC
71288-502
11-digit product format
712880502
Labeler code
71288
Product ID
71288-502_2cbc95d6-a15f-431f-9ff0-4827251bb767
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Haloperidol Decanoate
Dosage form
INJECTION
Route
INTRAMUSCULAR
Labeler
Meitheal Pharmaceuticals Inc.
Application
ANDA214507
Marketing category
ANDA
Marketing start
2021-07-26
Substance
HALOPERIDOL DECANOATE
Active strength
50 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 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
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71288-502-01Haloperidol Decanoate1 mL in 1 VIAL, SINGLE-DOSEINJECTION16
71288-502-02Haloperidol Decanoate10 in 1 CARTONINJECTION106

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71288-502-01ML - Milliliter71288-502bed017eb-2648-4548-a90e-e8239dcaedd512022-03-09
71288-502-02ML - Milliliter71288-50225559512-9489-496f-b43c-13561febf07b12022-03-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71288-502HALOPERIDOL DECANOATE INJECTION [MEITHEAL PHARMACEUTICALS INC.]5Current NDC, Legacy NDC, 2 package rows20250426_14f40303-9604-4a30-8e86-8abaeb177ce1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1719803haloperidol decanoate 100 MG in 1 ML InjectionPSN14f40303-9604-4a30-8e86-8abaeb177ce16
859871haloperidol decanoate 100 MG/ML Injectable SolutionPSN14f40303-9604-4a30-8e86-8abaeb177ce16
1719862haloperidol decanoate 50 MG in 1 ML InjectionPSN14f40303-9604-4a30-8e86-8abaeb177ce16
17198031 ML haloperidol decanoate 100 MG/ML InjectionSCD14f40303-9604-4a30-8e86-8abaeb177ce16
17198621 ML haloperidol decanoate 50 MG/ML InjectionSCD14f40303-9604-4a30-8e86-8abaeb177ce16
859871haloperidol decanoate 100 MG/ML Injectable SolutionSCD14f40303-9604-4a30-8e86-8abaeb177ce16
859871haloperidol 100 MG/ML (as haloperidol decanoate) Injectable SolutionSY14f40303-9604-4a30-8e86-8abaeb177ce16
1719803haloperidol decanoate 100 MG per 1 ML InjectionSY14f40303-9604-4a30-8e86-8abaeb177ce16
1719862haloperidol decanoate 50 MG per 1 ML InjectionSY14f40303-9604-4a30-8e86-8abaeb177ce16
1719862haloperidol decanoate 50 MG in 1 ML InjectionPSN4a3653df-84c7-46c2-b8fd-28c63cd2747a4
17198621 ML haloperidol decanoate 50 MG/ML InjectionSCD4a3653df-84c7-46c2-b8fd-28c63cd2747a4
1719862haloperidol decanoate 50 MG per 1 ML InjectionSY4a3653df-84c7-46c2-b8fd-28c63cd2747a4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71288-502-01712880502011 mL in 1 VIAL, SINGLE-DOSE1 mlHistorical
71288-502-027128805020210 VIAL, SINGLE-DOSE in 1 CARTON (71288-502-02) / 1 mL in 1 VIAL, SINGLE-DOSE (71288-502-01) 2021-07-260000-00-00NoNoCurrent