FDA.reportPublic FDA data

Haloperidol

Product NDC
51079-431
11-digit product format
510790431
Labeler code
51079
Product ID
51079-431_d347ec32-b81f-1638-e053-2995a90abefd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
haloperidol
Dosage form
TABLET
Route
ORAL
Labeler
Mylan Institutional Inc.
Application
ANDA070278
Marketing category
ANDA
Marketing start
2009-08-03
Marketing end
0000-00-00
Substance
HALOPERIDOL
Active strength
10 mg/1
Pharmacologic classes
Typical Antipsychotic [EPC]
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

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
51079-431-01Haloperidol1 in 1 BLISTER PACKTABLET118
51079-431-20Haloperidol100 in 1 CARTONTABLET10018

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51079-431-01EA - Each51079-431f370d60f-85c2-4237-9e1f-ce85c974eaa712012-07-24
51079-431-20EA - Each51079-4318488e0b1-bc7a-47e2-9012-b302de846ed212012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
HALOPERIDOLACTIVE INGREDIENTJ6292F8L3DHALOPERIDOL TABLET [MYLAN INSTITUTIONAL INC.]9
HALOPERIDOLACTIVE MOIETYJ6292F8L3DHALOPERIDOL TABLET [MYLAN INSTITUTIONAL INC.]9
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UHALOPERIDOL TABLET [MYLAN INSTITUTIONAL INC.]9
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDHALOPERIDOL TABLET [MYLAN INSTITUTIONAL INC.]9
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8HALOPERIDOL TABLET [MYLAN INSTITUTIONAL INC.]9
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30HALOPERIDOL TABLET [MYLAN INSTITUTIONAL INC.]9
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4HALOPERIDOL TABLET [MYLAN INSTITUTIONAL INC.]9
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JHALOPERIDOL TABLET [MYLAN INSTITUTIONAL INC.]9
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJHALOPERIDOL TABLET [MYLAN INSTITUTIONAL INC.]9

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51079-431HALOPERIDOL TABLET [MYLAN INSTITUTIONAL INC.]16Legacy NDC, 2 package rows20211217_ad7d2f17-a4e8-4ebc-9baf-5983ac626782.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310670haloperidol 0.5 MG Oral TabletPSNad7d2f17-a4e8-4ebc-9baf-5983ac62678218
310671haloperidol 1 MG Oral TabletPSNad7d2f17-a4e8-4ebc-9baf-5983ac62678218
314035haloperidol 10 MG Oral TabletPSNad7d2f17-a4e8-4ebc-9baf-5983ac62678218
314034haloperidol 2 MG Oral TabletPSNad7d2f17-a4e8-4ebc-9baf-5983ac62678218
310672haloperidol 5 MG Oral TabletPSNad7d2f17-a4e8-4ebc-9baf-5983ac62678218
310670haloperidol 0.5 MG Oral TabletSCDad7d2f17-a4e8-4ebc-9baf-5983ac62678218
310671haloperidol 1 MG Oral TabletSCDad7d2f17-a4e8-4ebc-9baf-5983ac62678218
314035haloperidol 10 MG Oral TabletSCDad7d2f17-a4e8-4ebc-9baf-5983ac62678218
314034haloperidol 2 MG Oral TabletSCDad7d2f17-a4e8-4ebc-9baf-5983ac62678218
310672haloperidol 5 MG Oral TabletSCDad7d2f17-a4e8-4ebc-9baf-5983ac62678218

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51079-431-01510790431011 in 1 BLISTER PACKHistorical
51079-431-2051079043120100 BLISTER PACK in 1 CARTON (51079-431-20) > 1 TABLET in 1 BLISTER PACK (51079-431-01) 100 blister pack2009-08-030000-00-00NoNoCurrent