Haloperidol

Product NDC
0121-0581
11-digit product format
001210581
Labeler code
0121
Product ID
0121-0581_0f6d8b89-8c33-4459-84af-e588eb27587c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Haloperidol
Dosage form
SOLUTION
Route
ORAL
Labeler
PAI Holdings, LLC dba PAI Pharma
Application
ANDA073037
Marketing category
ANDA
Marketing start
2009-11-10
Substance
HALOPERIDOL
Active strength
2 mg/mL
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/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiJ6292F8L3D
Rxcui141935

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
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
ce329990-eb12-45a5-87d5-ce5ef054ca71Product name220190930
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
597b1cfd-7b31-5048-62be-ca5cd740da2fProduct name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0121-0581-04Haloperidol120 mL in 1 BOTTLESOLUTION12015
0121-0581-05Haloperidol10 in 1 CASESOLUTION1015
0121-0581-05Haloperidol10 in 1 TRAYSOLUTION1015
0121-0581-15Haloperidol15 mL in 1 BOTTLESOLUTION1515

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0121-0581-04ML - Milliliter0121-05817936e21b-781d-419e-8b9c-7324f1dfe4f412012-07-24
0121-0581-05ML - Milliliter0121-05812d16f3e2-191e-4ce7-9087-5fd7d81ad71212012-07-24
0121-0581-15ML - Milliliter0121-0581361087fb-5e0f-48e4-87b9-a6da0b2f36f012021-02-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
HaloperidolACTIVE INGREDIENTJ6292F8L3DHALOPERIDOL SOLUTION, CONCENTRATE [PHARMACEUTICAL ASSOCIATES, INC.]4
HaloperidolACTIVE MOIETYJ6292F8L3DHALOPERIDOL SOLUTION, CONCENTRATE [PHARMACEUTICAL ASSOCIATES, INC.]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0121-0581HALOPERIDOL SOLUTION [PAI HOLDINGS, LLC DBA PAI PHARMA]15Current NDC, Legacy NDC, 4 package rows20250210_b488c106-f1ee-4b7b-8516-01162fb929f7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
141935haloperidol 2 MG in 1 mL Concentrate for Oral SolutionPSNb488c106-f1ee-4b7b-8516-01162fb929f715
141935haloperidol 2 MG/ML Oral SolutionSCDb488c106-f1ee-4b7b-8516-01162fb929f715
141935haloperidol 2 MG per 1 ML Concentrate for Oral SolutionSYb488c106-f1ee-4b7b-8516-01162fb929f715
141935haloperidol 2 MG in 1 mL Concentrate for Oral SolutionPSN599a6800-b2a8-41da-8733-577b819291c72
141935haloperidol 2 MG in 1 mL Concentrate for Oral SolutionPSN862d9bcd-aaaf-4b10-9013-f696f4cf95812
141935haloperidol 2 MG/ML Oral SolutionSCD599a6800-b2a8-41da-8733-577b819291c72
141935haloperidol 2 MG/ML Oral SolutionSCD862d9bcd-aaaf-4b10-9013-f696f4cf95812
141935haloperidol 2 MG per 1 ML Concentrate for Oral SolutionSY599a6800-b2a8-41da-8733-577b819291c72
141935haloperidol 2 MG per 1 ML Concentrate for Oral SolutionSY862d9bcd-aaaf-4b10-9013-f696f4cf95812

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0121-0581-0400121058104120 mL in 1 BOTTLE (0121-0581-04) 120 ml2009-11-100000-00-00NoNoCurrent
0121-0581-050012105810510 TRAY in 1 CASE (0121-0581-05) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE10 tray2009-11-100000-00-00NoNoCurrent
0121-0581-150012105811515 mL in 1 BOTTLE (0121-0581-15) 15 ml2020-06-120000-00-00NoNoCurrent