Haloperidol

Product NDC
27241-264
11-digit product format
272410264
Labeler code
27241
Product ID
27241-264_3af25358-362b-4046-98c9-1c12eb623e02
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Haloperidol
Dosage form
TABLET
Route
ORAL
Labeler
Ajanta Pharma USA Inc.
Application
ANDA218210
Marketing category
ANDA
Marketing start
2026-09-14
Substance
HALOPERIDOL
Active strength
.5 mg/1
Pharmacologic classes
Typical Antipsychotic [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog.

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
Haloperidol
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HALOPERIDOL.5 mg/1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
27241-264-0127241026401100 TABLET in 1 BOTTLE (27241-264-01) 100 tablet2026-09-14NoNoCurrent