FDA.reportPublic FDA data

Haloperidol Decanoate

Product NDC
70518-3743
11-digit product format
705183743
Labeler code
70518
Product ID
70518-3743_4f823a30-72ec-9b23-e063-6294a90a1908
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Haloperidol Decanoate
Dosage form
INJECTION
Route
INTRAMUSCULAR
Labeler
REMEDYREPACK INC.
Application
ANDA214507
Marketing category
ANDA
Marketing start
2023-06-02
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
Rxcui1719862

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
70518-3743-0Haloperidol Decanoate10 in 1 CARTONINJECTION104
70518-3743-1Haloperidol Decanoate1 mL in 1 VIAL, SINGLE-DOSEINJECTION14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-3743HALOPERIDOL DECANOATE INJECTION [REMEDYREPACK INC.]2Current NDC, 2 package rows20240329_4a3653df-84c7-46c2-b8fd-28c63cd2747a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
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 startSampleExclude flagStatus
70518-3743-07051837430010 VIAL, SINGLE-DOSE in 1 CARTON (70518-3743-0) / 1 mL in 1 VIAL, SINGLE-DOSE (70518-3743-1) 2023-06-02NoNoHistorical
70518-3743-1705183743011 mL in 1 VIAL, SINGLE-DOSE1 mlHistorical