Haloperidol

Product NDC
69292-590
11-digit product format
692920590
Labeler code
69292
Product ID
69292-590_8c9cdd3d-9751-404a-9ceb-276e8dfa6391
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Haloperidol
Dosage form
TABLET
Route
ORAL
Labeler
Amici Pharmaceuticals, LLC
Application
ANDA071173
Marketing category
ANDA
Marketing start
2022-04-18
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
69292-590-01Haloperidol100 in 1 BOTTLETABLET1002

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69292-590-01EA - Each69292-59012265f87-f075-47c3-a1cd-78d6c5fbd95212022-05-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69292-590HALOPERIDOL TABLET [AMICI PHARMACEUTICALS, LLC]2Current NDC, Legacy NDC, 1 package rows20220503_9a9e20dd-646a-4fe9-a345-1b5bda8e7775.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310670haloperidol 0.5 MG Oral TabletPSN9a9e20dd-646a-4fe9-a345-1b5bda8e77752
310671haloperidol 1 MG Oral TabletPSN9a9e20dd-646a-4fe9-a345-1b5bda8e77752
314035haloperidol 10 MG Oral TabletPSN9a9e20dd-646a-4fe9-a345-1b5bda8e77752
314034haloperidol 2 MG Oral TabletPSN9a9e20dd-646a-4fe9-a345-1b5bda8e77752
197754haloperidol 20 MG Oral TabletPSN9a9e20dd-646a-4fe9-a345-1b5bda8e77752
310672haloperidol 5 MG Oral TabletPSN9a9e20dd-646a-4fe9-a345-1b5bda8e77752
310670haloperidol 0.5 MG Oral TabletSCD9a9e20dd-646a-4fe9-a345-1b5bda8e77752
310671haloperidol 1 MG Oral TabletSCD9a9e20dd-646a-4fe9-a345-1b5bda8e77752
314035haloperidol 10 MG Oral TabletSCD9a9e20dd-646a-4fe9-a345-1b5bda8e77752
314034haloperidol 2 MG Oral TabletSCD9a9e20dd-646a-4fe9-a345-1b5bda8e77752
197754haloperidol 20 MG Oral TabletSCD9a9e20dd-646a-4fe9-a345-1b5bda8e77752
310672haloperidol 5 MG Oral TabletSCD9a9e20dd-646a-4fe9-a345-1b5bda8e77752

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69292-590-0169292059001100 TABLET in 1 BOTTLE (69292-590-01) 100 tablet2022-04-180000-00-00NoNoCurrent