Haloperidol Decanoate

Product NDC
72603-230
11-digit product format
726030230
Labeler code
72603
Product ID
72603-230_5f6d0f73-2b79-472a-94ce-ac8b0d31201d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Haloperidol Decanoate
Dosage form
INJECTION
Route
INTRAMUSCULAR
Labeler
NorthStar RxLLC
Application
ANDA216730
Marketing category
ANDA
Marketing start
2023-12-01
Substance
HALOPERIDOL DECANOATE
Active strength
100 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 DECANOATE100 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiAC20PJ4101
Rxcui1719803

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
72603-230-01Haloperidol Decanoate1 in 1 CARTONINJECTION14
72603-230-01Haloperidol Decanoate1 mL in 1 VIALINJECTION14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72603-230-01ML - Milliliter72603-23031d9f662-534b-4540-93a3-7c631d0c847512024-01-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72603-230HALOPERIDOL DECANOATE INJECTION [NORTHSTAR RXLLC]3Current NDC, 2 package rows20250302_b83cb022-cfeb-4492-927b-0b461f7201d4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1719803haloperidol decanoate 100 MG in 1 ML InjectionPSNb83cb022-cfeb-4492-927b-0b461f7201d44
17198031 ML haloperidol decanoate 100 MG/ML InjectionSCDb83cb022-cfeb-4492-927b-0b461f7201d44
1719803haloperidol decanoate 100 MG per 1 ML InjectionSYb83cb022-cfeb-4492-927b-0b461f7201d44

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72603-230-01726030230011 VIAL in 1 CARTON (72603-230-01) / 1 mL in 1 VIAL1 vial2023-12-01NoNoCurrent