Haloperidol

Product NDC
58657-903
11-digit product format
586570903
Labeler code
58657
Product ID
58657-903_38c21c0c-f6b3-adda-e063-6294a90a0ffd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Haloperidol
Dosage form
TABLET
Route
ORAL
Labeler
Method Pharmaceuticals, LLC
Application
ANDA071173
Marketing category
ANDA
Marketing start
2025-06-05
Substance
HALOPERIDOL
Active strength
5 mg/1
Pharmacologic classes
Typical Antipsychotic [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
J6292F8L3DHALOPERIDOL52-86-8HALOPERIDOL

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
58657-903-0158657090301100 TABLET in 1 CARTON (58657-903-01) 100 tablet2025-06-05NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Haloperidol Tablets, USPMethod Pharmaceuticals, LLC2025-06-29HUMAN PRESCRIPTION DRUG LABEL7