Haloperidol

Product NDC
51079-734
11-digit product format
510790734
Labeler code
51079
Product ID
51079-734_3dd4fea4-d455-5a4d-e063-6394a90ab14c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
haloperidol
Dosage form
TABLET
Route
ORAL
Labeler
Mylan Institutional Inc.
Application
ANDA070278
Marketing category
ANDA
Marketing start
2004-02-01
Substance
HALOPERIDOL
Active strength
1 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
HALOPERIDOL1 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiJ6292F8L3D
Rxcui310670, 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
51079-734-01Haloperidol1 in 1 BLISTER PACKTABLET118
51079-734-20Haloperidol100 in 1 CARTONTABLET10018

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51079-734-01EA - Each51079-73456e00373-d10b-4f4b-95ea-ab66840f942412012-07-24
51079-734-20EA - Each51079-73418da52cc-aa53-4bb6-bbbd-5f154c4d218012012-07-24

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
51079-734HALOPERIDOL TABLET [MYLAN INSTITUTIONAL INC.]16Current NDC, Legacy 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
51079-734-01510790734011 in 1 BLISTER PACKHistorical
51079-734-2051079073420100 BLISTER PACK in 1 CARTON (51079-734-20) / 1 TABLET in 1 BLISTER PACK (51079-734-01) 100 blister pack2004-02-010000-00-00NoNoCurrent