Haloperidol

Product NDC
68382-080
11-digit product format
683820080
Labeler code
68382
Product ID
68382-080_8d46c061-97af-4b2c-a788-bb08031d2c6f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Haloperidol
Dosage form
TABLET
Route
ORAL
Labeler
Zydus Pharmaceuticals USA Inc.
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
68382-080-01Haloperidol100 in 1 BOTTLETABLET10015
68382-080-06Haloperidol30 in 1 BOTTLETABLET3015
68382-080-10Haloperidol1000 in 1 BOTTLETABLET100015

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68382-080HALOPERIDOL TABLET [ZYDUS PHARMACEUTICALS USA INC.]15Current NDC, Legacy NDC, 3 package rows20241120_54502f78-7244-454a-9171-4e73127f1456.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310670haloperidol 0.5 MG Oral TabletPSN54502f78-7244-454a-9171-4e73127f145615
310671haloperidol 1 MG Oral TabletPSN54502f78-7244-454a-9171-4e73127f145615
314035haloperidol 10 MG Oral TabletPSN54502f78-7244-454a-9171-4e73127f145615
314034haloperidol 2 MG Oral TabletPSN54502f78-7244-454a-9171-4e73127f145615
197754haloperidol 20 MG Oral TabletPSN54502f78-7244-454a-9171-4e73127f145615
310672haloperidol 5 MG Oral TabletPSN54502f78-7244-454a-9171-4e73127f145615
310670haloperidol 0.5 MG Oral TabletSCD54502f78-7244-454a-9171-4e73127f145615
310671haloperidol 1 MG Oral TabletSCD54502f78-7244-454a-9171-4e73127f145615
314035haloperidol 10 MG Oral TabletSCD54502f78-7244-454a-9171-4e73127f145615
314034haloperidol 2 MG Oral TabletSCD54502f78-7244-454a-9171-4e73127f145615
197754haloperidol 20 MG Oral TabletSCD54502f78-7244-454a-9171-4e73127f145615
310672haloperidol 5 MG Oral TabletSCD54502f78-7244-454a-9171-4e73127f145615
314035haloperidol 10 MG Oral TabletPSN746f3ab9-9e6e-4ce8-9384-0c7a57de800713
314035haloperidol 10 MG Oral TabletSCD746f3ab9-9e6e-4ce8-9384-0c7a57de800713
314035haloperidol 10 MG Oral TabletPSNe07f02d4-2768-4978-97ee-23ac52d0b84611
314035haloperidol 10 MG Oral TabletPSN0ac0cc44-3924-447d-9051-f84c4431238011
197754haloperidol 20 MG Oral TabletPSN0ac0cc44-3924-447d-9051-f84c4431238011
197754haloperidol 20 MG Oral TabletPSNe07f02d4-2768-4978-97ee-23ac52d0b84611
310672haloperidol 5 MG Oral TabletPSNe07f02d4-2768-4978-97ee-23ac52d0b84611
314035haloperidol 10 MG Oral TabletSCDe07f02d4-2768-4978-97ee-23ac52d0b84611
314035haloperidol 10 MG Oral TabletSCD0ac0cc44-3924-447d-9051-f84c4431238011
197754haloperidol 20 MG Oral TabletSCDe07f02d4-2768-4978-97ee-23ac52d0b84611
197754haloperidol 20 MG Oral TabletSCD0ac0cc44-3924-447d-9051-f84c4431238011
310672haloperidol 5 MG Oral TabletSCDe07f02d4-2768-4978-97ee-23ac52d0b84611
314035haloperidol 10 MG Oral TabletPSNdef76be8-49c2-4e7d-832f-2bfb1fc090ac2
314035haloperidol 10 MG Oral TabletSCDdef76be8-49c2-4e7d-832f-2bfb1fc090ac2
314035haloperidol 10 MG Oral TabletPSN509e5424-1323-c841-e063-6294a90a27141
314035haloperidol 10 MG Oral TabletSCD509e5424-1323-c841-e063-6294a90a27141

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68382-080-0168382008001100 TABLET in 1 BOTTLE (68382-080-01) 100 tablet2008-01-030000-00-00NoNoCurrent
68382-080-066838200800630 TABLET in 1 BOTTLE (68382-080-06) 30 tablet2008-01-030000-00-00NoNoCurrent
68382-080-10683820080101000 TABLET in 1 BOTTLE (68382-080-10) 1000 tablet2008-01-030000-00-00NoNoCurrent