FDA.reportPublic FDA data

Haloperidol

Product NDC
65841-627
11-digit product format
658410627
Labeler code
65841
Product ID
65841-627_2ff366f9-878f-4fcb-b2d4-00fb6e31ecbf
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Haloperidol
Dosage form
TABLET
Route
ORAL
Labeler
Zydus Lifesciences Limited
Application
ANDA077580
Marketing category
ANDA
Marketing start
2008-01-03
Substance
HALOPERIDOL
Active strength
10 mg/1
Pharmacologic classes
Typical Antipsychotic [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Haloperidol
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HALOPERIDOL10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiJ6292F8L3D
Rxcui197754, 310670, 310671, 310672, 314034, 314035

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d599bae4-cb25-0798-7468-31aa188fb750Product name720260304
6aae29ef-bf3c-3ebb-3bf1-10ee5424a22eProduct name220250114
af58e43a-5792-c2c1-8e57-a2454df1f2c0Product name320240202
ce329990-eb12-45a5-87d5-ce5ef054ca71Product name220190930

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65841-627-01Haloperidol100 in 1 BOTTLETABLET1008
65841-627-10Haloperidol1000 in 1 BOTTLETABLET10008

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65841-627HALOPERIDOL TABLET [ZYDUS LIFESCIENCES LIMITED]8Current NDC, Legacy NDC, 2 package rows20241201_509d0eb2-b930-4836-9669-dbebf0ac4076.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310670haloperidol 0.5 MG Oral TabletPSN509d0eb2-b930-4836-9669-dbebf0ac40768
310671haloperidol 1 MG Oral TabletPSN509d0eb2-b930-4836-9669-dbebf0ac40768
314035haloperidol 10 MG Oral TabletPSN509d0eb2-b930-4836-9669-dbebf0ac40768
314034haloperidol 2 MG Oral TabletPSN509d0eb2-b930-4836-9669-dbebf0ac40768
197754haloperidol 20 MG Oral TabletPSN509d0eb2-b930-4836-9669-dbebf0ac40768
310672haloperidol 5 MG Oral TabletPSN509d0eb2-b930-4836-9669-dbebf0ac40768
310670haloperidol 0.5 MG Oral TabletSCD509d0eb2-b930-4836-9669-dbebf0ac40768
310671haloperidol 1 MG Oral TabletSCD509d0eb2-b930-4836-9669-dbebf0ac40768
314035haloperidol 10 MG Oral TabletSCD509d0eb2-b930-4836-9669-dbebf0ac40768
314034haloperidol 2 MG Oral TabletSCD509d0eb2-b930-4836-9669-dbebf0ac40768
197754haloperidol 20 MG Oral TabletSCD509d0eb2-b930-4836-9669-dbebf0ac40768
310672haloperidol 5 MG Oral TabletSCD509d0eb2-b930-4836-9669-dbebf0ac40768

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65841-627-0165841062701100 TABLET in 1 BOTTLE (65841-627-01) 100 tablet2008-01-030000-00-00NoNoCurrent
65841-627-10658410627101000 TABLET in 1 BOTTLE (65841-627-10) 1000 tablet2008-01-030000-00-00NoNoCurrent