Haloperidol

Product NDC
67046-0053
11-digit product format
670460053
Labeler code
67046
Product ID
67046-0053_38f58246-c2e2-01f8-e063-6394a90a3b7d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Haloperidol
Dosage form
TABLET
Route
ORAL
Labeler
Coupler LLC
Application
ANDA071173
Marketing category
ANDA
Marketing start
2025-07-02
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
67046-0053-36704600530330 TABLET in 1 BLISTER PACK (67046-0053-3) 30 tablet2025-07-02NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Haloperidol Tablets, USPCoupler LLC2025-07-02HUMAN PRESCRIPTION DRUG LABEL1