Haloperidol Decanoate

Product NDC
72485-520
11-digit product format
724850520
Labeler code
72485
Product ID
72485-520_f80ebd1c-e43e-4e6a-bbd0-96cfabafb548
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Haloperidol Decanoate
Dosage form
INJECTION
Route
INTRAMUSCULAR
Labeler
Armas Pharmaceuticals Inc.
Application
ANDA219168
Marketing category
ANDA
Marketing start
2026-05-15
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

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
AC20PJ4101HALOPERIDOL DECANOATE74050-97-8HALOPERIDOL DECANOATE

Packages

Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
72485-520-107248505201010 VIAL, SINGLE-DOSE in 1 CARTON (72485-520-10) / 1 mL in 1 VIAL, SINGLE-DOSE (72485-520-01) 2026-05-15NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Haloperidol Decanoate Injection For Intramuscular Injection Only Rx OnlyArmas Pharmaceuticals Inc.2026-05-15Human Prescription Drug Label1