FDA.reportPublic FDA data

Haloperidol

Product NDC
71247-154
11-digit product format
712470154
Labeler code
71247
Product ID
71247-154_ef4d587e-1e3e-4dbd-82f8-b102ec30df12
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Haloperidol
Dosage form
TABLET
Route
ORAL
Labeler
Innogenix, Inc.
Application
ANDA071173
Marketing category
ANDA
Marketing start
2021-02-18
Substance
HALOPERIDOL
Active strength
10 mg/1
Pharmacologic classes
Typical Antipsychotic [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Haloperidol
Listing expiration
2027-12-31

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
71247-154-01Haloperidol100 in 1 BOTTLETABLET1004
71247-154-10Haloperidol1000 in 1 BOTTLETABLET10004

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71247-154-01EA - Each71247-154c1b26c5c-6bde-4d21-bbda-cde94fab940812021-07-15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71247-154HALOPERIDOL TABLET [INNOGENIX, INC.]2Current NDC, Legacy NDC, 2 package rows20230113_2c26af24-5ed3-4eb7-8d29-d6a019320a70.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310670haloperidol 0.5 MG Oral TabletPSN2c26af24-5ed3-4eb7-8d29-d6a019320a704
310671haloperidol 1 MG Oral TabletPSN2c26af24-5ed3-4eb7-8d29-d6a019320a704
314035haloperidol 10 MG Oral TabletPSN2c26af24-5ed3-4eb7-8d29-d6a019320a704
314034haloperidol 2 MG Oral TabletPSN2c26af24-5ed3-4eb7-8d29-d6a019320a704
197754haloperidol 20 MG Oral TabletPSN2c26af24-5ed3-4eb7-8d29-d6a019320a704
310672haloperidol 5 MG Oral TabletPSN2c26af24-5ed3-4eb7-8d29-d6a019320a704
310670haloperidol 0.5 MG Oral TabletSCD2c26af24-5ed3-4eb7-8d29-d6a019320a704
310671haloperidol 1 MG Oral TabletSCD2c26af24-5ed3-4eb7-8d29-d6a019320a704
314035haloperidol 10 MG Oral TabletSCD2c26af24-5ed3-4eb7-8d29-d6a019320a704
314034haloperidol 2 MG Oral TabletSCD2c26af24-5ed3-4eb7-8d29-d6a019320a704
197754haloperidol 20 MG Oral TabletSCD2c26af24-5ed3-4eb7-8d29-d6a019320a704
310672haloperidol 5 MG Oral TabletSCD2c26af24-5ed3-4eb7-8d29-d6a019320a704

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71247-154-0171247015401100 TABLET in 1 BOTTLE (71247-154-01) 100 tablet2021-02-180000-00-00NoNoCurrent
71247-154-10712470154101000 TABLET in 1 BOTTLE (71247-154-10) 1000 tablet2021-02-180000-00-00NoNoCurrent