FDA.reportPublic FDA data

Haloperidol

Product NDC
58657-704
11-digit product format
586570704
Labeler code
58657
Product ID
58657-704_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
2019-11-25
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
58657-704-01Haloperidol100 in 1 BOTTLETABLET1007
58657-704-10Haloperidol1000 in 1 BOTTLETABLET10007

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
58657-704-01EA - Each58657-704b692673e-00cd-4296-9539-6c740478604d12020-01-03

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58657-704HALOPERIDOL TABLET [METHOD PHARMACEUTICALS, LLC]6Current NDC, Legacy NDC, 2 package rows20241130_87f8773b-bf89-4f7e-bff4-8cad117d5776.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314035haloperidol 10 MG Oral TabletPSNdf340d75-7387-4084-9d76-167283ee7462105
314035haloperidol 10 MG Oral TabletSCDdf340d75-7387-4084-9d76-167283ee7462105
314035haloperidol 10 MG Oral TabletPSNb9e8f5f2-6d59-4a2c-8ccf-88bb58753f60101
314035haloperidol 10 MG Oral TabletSCDb9e8f5f2-6d59-4a2c-8ccf-88bb58753f60101
310670haloperidol 0.5 MG Oral TabletPSN87f8773b-bf89-4f7e-bff4-8cad117d57767
310671haloperidol 1 MG Oral TabletPSN87f8773b-bf89-4f7e-bff4-8cad117d57767
314035haloperidol 10 MG Oral TabletPSN87f8773b-bf89-4f7e-bff4-8cad117d57767
314034haloperidol 2 MG Oral TabletPSN87f8773b-bf89-4f7e-bff4-8cad117d57767
197754haloperidol 20 MG Oral TabletPSN87f8773b-bf89-4f7e-bff4-8cad117d57767
310672haloperidol 5 MG Oral TabletPSN87f8773b-bf89-4f7e-bff4-8cad117d57767
310670haloperidol 0.5 MG Oral TabletSCD87f8773b-bf89-4f7e-bff4-8cad117d57767
310671haloperidol 1 MG Oral TabletSCD87f8773b-bf89-4f7e-bff4-8cad117d57767
314035haloperidol 10 MG Oral TabletSCD87f8773b-bf89-4f7e-bff4-8cad117d57767
314034haloperidol 2 MG Oral TabletSCD87f8773b-bf89-4f7e-bff4-8cad117d57767
197754haloperidol 20 MG Oral TabletSCD87f8773b-bf89-4f7e-bff4-8cad117d57767
310672haloperidol 5 MG Oral TabletSCD87f8773b-bf89-4f7e-bff4-8cad117d57767
314035haloperidol 10 MG Oral TabletPSNa3afd19a-c340-4fad-8ddd-d712425153456
314035haloperidol 10 MG Oral TabletSCDa3afd19a-c340-4fad-8ddd-d712425153456

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
58657-704-0158657070401100 TABLET in 1 BOTTLE (58657-704-01) 100 tablet2019-11-250000-00-00NoNoCurrent
58657-704-10586570704101000 TABLET in 1 BOTTLE (58657-704-10) 1000 tablet2019-11-250000-00-00NoNoCurrent