FDA.reportPublic FDA data

Haloperidol

Product NDC
60687-799
11-digit product format
606870799
Labeler code
60687
Product ID
60687-799_2e1c7e24-1a56-569f-e063-6294a90ad540
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Haloperidol
Dosage form
SOLUTION
Route
ORAL
Labeler
American Health Packaging
Application
ANDA073037
Marketing category
ANDA
Marketing start
2024-04-15
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
ce329990-eb12-45a5-87d5-ce5ef054ca71Product name220190930

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
60687-799-17Haloperidol10 in 1 CASESOLUTION102
60687-799-40Haloperidol5 mL in 1 CUP, UNIT-DOSESOLUTION52
60687-799-46Haloperidol10 in 1 TRAYSOLUTION102

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60687-799-17ML - Milliliter60687-799ee109afd-861f-49dd-b356-d04668b96faa12024-04-05
60687-799-40ML - Milliliter60687-79987c0ed40-dd71-4f4b-85fc-498e24c926c112024-04-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60687-799HALOPERIDOL SOLUTION [AMERICAN HEALTH PACKAGING]2Current NDC, 3 package rows20250221_862d9bcd-aaaf-4b10-9013-f696f4cf9581.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
141935haloperidol 2 MG in 1 mL Concentrate for Oral SolutionPSN862d9bcd-aaaf-4b10-9013-f696f4cf95812
141935haloperidol 2 MG/ML Oral SolutionSCD862d9bcd-aaaf-4b10-9013-f696f4cf95812
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 startSampleExclude flagStatus
60687-799-176068707991710 TRAY in 1 CASE (60687-799-17) / 10 CUP, UNIT-DOSE in 1 TRAY (60687-799-46) / 5 mL in 1 CUP, UNIT-DOSE (60687-799-40) 10 tray2024-04-15NoNoHistorical
60687-799-40606870799405 mL in 1 CUP, UNIT-DOSE5 mlHistorical
60687-799-466068707994610 in 1 TRAYHistorical