FDA.reportPublic FDA data

Haloperidol

Product NDC
68084-250
11-digit product format
680840250
Labeler code
68084
Product ID
68084-250_37b3725e-fe41-d384-e063-6294a90a61da
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Haloperidol
Dosage form
TABLET
Route
ORAL
Labeler
American Health Packaging
Application
ANDA077580
Marketing category
ANDA
Marketing start
2008-04-04
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, 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
68084-250-11Haloperidol1 in 1 BLISTER PACKTABLET111
68084-250-21Haloperidol30 in 1 BOX, UNIT-DOSETABLET3011

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68084-250-11EA - Each68084-2506bcabb55-6169-4073-87c3-b2e1d3caa6d012014-02-04
68084-250-21EA - Each68084-250b03276a2-9cd3-4dfb-a9ec-bb26dc5e847c12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
HALOPERIDOLACTIVE INGREDIENTJ6292F8L3DHALOPERIDOL TABLET [AMERICAN HEALTH PACKAGING]2
HALOPERIDOLACTIVE MOIETYJ6292F8L3DHALOPERIDOL TABLET [AMERICAN HEALTH PACKAGING]2
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATEINACTIVE INGREDIENTO7TSZ97GEPHALOPERIDOL TABLET [AMERICAN HEALTH PACKAGING]2
CALCIUM STEARATEINACTIVE INGREDIENT776XM7047LHALOPERIDOL TABLET [AMERICAN HEALTH PACKAGING]2
D&C RED NO. 27INACTIVE INGREDIENT2LRS185U6KHALOPERIDOL TABLET [AMERICAN HEALTH PACKAGING]2
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GHALOPERIDOL TABLET [AMERICAN HEALTH PACKAGING]2
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDHALOPERIDOL TABLET [AMERICAN HEALTH PACKAGING]2
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8HALOPERIDOL TABLET [AMERICAN HEALTH PACKAGING]2
POVIDONE K30INACTIVE INGREDIENTU725QWY32XHALOPERIDOL TABLET [AMERICAN HEALTH PACKAGING]2
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2HALOPERIDOL TABLET [AMERICAN HEALTH PACKAGING]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJHALOPERIDOL TABLET [AMERICAN HEALTH PACKAGING]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68084-250HALOPERIDOL TABLET [AMERICAN HEALTH PACKAGING]10Current NDC, Legacy NDC, 2 package rows20240723_0ac0cc44-3924-447d-9051-f84c44312380.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314035haloperidol 10 MG Oral TabletPSN0ac0cc44-3924-447d-9051-f84c4431238011
197754haloperidol 20 MG Oral TabletPSN0ac0cc44-3924-447d-9051-f84c4431238011
314035haloperidol 10 MG Oral TabletSCD0ac0cc44-3924-447d-9051-f84c4431238011
197754haloperidol 20 MG Oral TabletSCD0ac0cc44-3924-447d-9051-f84c4431238011

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68084-250-11680840250111 in 1 BLISTER PACKHistorical
68084-250-216808402502130 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-250-21) / 1 TABLET in 1 BLISTER PACK (68084-250-11) 30 blister pack2008-04-040000-00-00NoNoCurrent