FDA.reportPublic FDA data

Haloperidol

Product NDC
10135-757
11-digit product format
101350757
Labeler code
10135
Product ID
10135-757_23e5e8d5-bddd-f9a9-e063-6394a90adb0c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Haloperidol
Dosage form
TABLET
Route
ORAL
Labeler
Marlex Pharmaceuticals, Inc.
Application
ANDA071173
Marketing category
ANDA
Marketing start
2022-08-01
Substance
HALOPERIDOL
Active strength
20 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
HALOPERIDOL20 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
10135-757-01Haloperidol100 in 1 BOTTLETABLET1002
10135-757-10Haloperidol1000 in 1 BOTTLETABLET10002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10135-757HALOPERIDOL TABLET [MARLEX PHARMACEUTICALS, INC.]2Current NDC, Legacy NDC, 2 package rows20241009_e7a61604-741f-2d3b-e053-2995a90a62fc.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310670haloperidol 0.5 MG Oral TabletPSNe7a61604-741f-2d3b-e053-2995a90a62fc2
310671haloperidol 1 MG Oral TabletPSNe7a61604-741f-2d3b-e053-2995a90a62fc2
314035haloperidol 10 MG Oral TabletPSNe7a61604-741f-2d3b-e053-2995a90a62fc2
314034haloperidol 2 MG Oral TabletPSNe7a61604-741f-2d3b-e053-2995a90a62fc2
197754haloperidol 20 MG Oral TabletPSNe7a61604-741f-2d3b-e053-2995a90a62fc2
310672haloperidol 5 MG Oral TabletPSNe7a61604-741f-2d3b-e053-2995a90a62fc2
310670haloperidol 0.5 MG Oral TabletSCDe7a61604-741f-2d3b-e053-2995a90a62fc2
310671haloperidol 1 MG Oral TabletSCDe7a61604-741f-2d3b-e053-2995a90a62fc2
314035haloperidol 10 MG Oral TabletSCDe7a61604-741f-2d3b-e053-2995a90a62fc2
314034haloperidol 2 MG Oral TabletSCDe7a61604-741f-2d3b-e053-2995a90a62fc2
197754haloperidol 20 MG Oral TabletSCDe7a61604-741f-2d3b-e053-2995a90a62fc2
310672haloperidol 5 MG Oral TabletSCDe7a61604-741f-2d3b-e053-2995a90a62fc2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
10135-757-0110135075701100 TABLET in 1 BOTTLE (10135-757-01) 100 tablet2022-08-010000-00-00NoNoCurrent
10135-757-10101350757101000 TABLET in 1 BOTTLE (10135-757-10) 1000 tablet2022-08-010000-00-00NoNoCurrent