Haloperidol

Product NDC
68382-409
11-digit product format
683820409
Labeler code
68382
Product ID
68382-409_8d46c061-97af-4b2c-a788-bb08031d2c6f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Haloperidol
Dosage form
TABLET
Route
ORAL
Labeler
Zydus Pharmaceuticals USA Inc.
Application
ANDA077580
Marketing category
ANDA
Marketing start
2023-02-01
Substance
HALOPERIDOL
Active strength
2 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
HALOPERIDOL2 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
68382-409-01Haloperidol100 in 1 BOTTLETABLET10015
68382-409-10Haloperidol1000 in 1 BOTTLETABLET100015
68382-409-30Haloperidol10 in 1 BLISTER PACKTABLET1015
68382-409-77Haloperidol10 in 1 CARTONTABLET1015

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68382-409-01EA - Each68382-409bf12aacf-0422-4dc8-9bb8-d7b9fb06206412023-04-07

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
HALOPERIDOLACTIVE INGREDIENTJ6292F8L3DHALOPERIDOL TABLET [ZYDUS PHARMACEUTICALS (USA) INC.]5
HALOPERIDOLACTIVE MOIETYJ6292F8L3DHALOPERIDOL TABLET [ZYDUS PHARMACEUTICALS (USA) INC.]5
CALCIUM STEARATEINACTIVE INGREDIENT776XM7047LHALOPERIDOL TABLET [ZYDUS PHARMACEUTICALS (USA) INC.]5
D&C RED NO. 27INACTIVE INGREDIENT2LRS185U6KHALOPERIDOL TABLET [ZYDUS PHARMACEUTICALS (USA) INC.]5
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GHALOPERIDOL TABLET [ZYDUS PHARMACEUTICALS (USA) INC.]5
DIBASIC CALCIUM PHOSPHATE DIHYDRATEINACTIVE INGREDIENTO7TSZ97GEPHALOPERIDOL TABLET [ZYDUS PHARMACEUTICALS (USA) INC.]5
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDHALOPERIDOL TABLET [ZYDUS PHARMACEUTICALS (USA) INC.]5
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8HALOPERIDOL TABLET [ZYDUS PHARMACEUTICALS (USA) INC.]5
POVIDONE K30INACTIVE INGREDIENTU725QWY32XHALOPERIDOL TABLET [ZYDUS PHARMACEUTICALS (USA) INC.]5
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2HALOPERIDOL TABLET [ZYDUS PHARMACEUTICALS (USA) INC.]5
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJHALOPERIDOL TABLET [ZYDUS PHARMACEUTICALS (USA) INC.]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68382-409HALOPERIDOL TABLET [ZYDUS PHARMACEUTICALS USA INC.]15Current NDC, 4 package rows20241120_54502f78-7244-454a-9171-4e73127f1456.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310670haloperidol 0.5 MG Oral TabletPSN54502f78-7244-454a-9171-4e73127f145615
310671haloperidol 1 MG Oral TabletPSN54502f78-7244-454a-9171-4e73127f145615
314035haloperidol 10 MG Oral TabletPSN54502f78-7244-454a-9171-4e73127f145615
314034haloperidol 2 MG Oral TabletPSN54502f78-7244-454a-9171-4e73127f145615
197754haloperidol 20 MG Oral TabletPSN54502f78-7244-454a-9171-4e73127f145615
310672haloperidol 5 MG Oral TabletPSN54502f78-7244-454a-9171-4e73127f145615
310670haloperidol 0.5 MG Oral TabletSCD54502f78-7244-454a-9171-4e73127f145615
310671haloperidol 1 MG Oral TabletSCD54502f78-7244-454a-9171-4e73127f145615
314035haloperidol 10 MG Oral TabletSCD54502f78-7244-454a-9171-4e73127f145615
314034haloperidol 2 MG Oral TabletSCD54502f78-7244-454a-9171-4e73127f145615
197754haloperidol 20 MG Oral TabletSCD54502f78-7244-454a-9171-4e73127f145615
310672haloperidol 5 MG Oral TabletSCD54502f78-7244-454a-9171-4e73127f145615
314034haloperidol 2 MG Oral TabletPSN26a590a4-bcbb-a9cd-e063-6394a90a2aac1
314034haloperidol 2 MG Oral TabletSCD26a590a4-bcbb-a9cd-e063-6394a90a2aac1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68382-409-0168382040901100 TABLET in 1 BOTTLE (68382-409-01) 100 tablet2023-02-01NoNoCurrent
68382-409-10683820409101000 TABLET in 1 BOTTLE (68382-409-10) 1000 tablet2023-02-01NoNoCurrent
68382-409-306838204093010 in 1 BLISTER PACKHistorical
68382-409-776838204097710 BLISTER PACK in 1 CARTON (68382-409-77) / 10 TABLET in 1 BLISTER PACK (68382-409-30) 10 blister pack2023-02-01NoNoCurrent