Haloperidol decanoate

Product NDC
72785-0004
11-digit product format
727850004
Labeler code
72785
Product ID
72785-0004_ed63a7e6-a769-4c05-8e33-d724debffa7e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Haloperidol decanoate
Dosage form
INJECTION
Route
INTRAMUSCULAR
Labeler
Zydus Lifesciences Limited
Application
ANDA211180
Marketing category
ANDA
Marketing start
2019-11-14
Marketing end
0000-00-00
Substance
HALOPERIDOL DECANOATE
Active strength
50 mg/mL
Pharmacologic classes
Typical Antipsychotic [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
72785-0004-67278500040610 VIAL, SINGLE-DOSE in 1 CARTON (72785-0004-6) > 1 mL in 1 VIAL, SINGLE-DOSE (72785-0004-1) 2019-11-140000-00-00NoNoCurrent
72785-0004-9727850004093 VIAL, SINGLE-DOSE in 1 CARTON (72785-0004-9) > 1 mL in 1 VIAL, SINGLE-DOSE (72785-0004-1) 2019-11-140000-00-00NoNoCurrent