FDA.reportPublic FDA data

HALOPERIDOL DECANOATE

Product NDC
68001-578
11-digit product format
680010578
Labeler code
68001
Product ID
68001-578_048557ea-f859-f0f2-e063-6294a90af5ab
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
HALOPERIDOL DECANOATE
Dosage form
INJECTION
Route
INTRAMUSCULAR
Labeler
BluePoint Laboratories
Application
ANDA209101
Marketing category
ANDA
Marketing start
2023-09-15
Substance
HALOPERIDOL DECANOATE
Active strength
50 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 DECANOATE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HALOPERIDOL DECANOATE50 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiAC20PJ4101
Rxcui859871, 1719803, 1719862

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
68001-578-48HALOPERIDOL DECANOATE3 in 1 CARTONINJECTION33
68001-578-59HALOPERIDOL DECANOATE1 mL in 1 AMPULEINJECTION13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68001-578-48ML - Milliliter68001-5786e5ec7bd-dae4-4707-bb62-0eeff5807b2412023-06-06
68001-578-59ML - Milliliter68001-578b8cfb930-5e16-4ed9-92d4-0c552167154712023-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68001-578HALOPERIDOL DECANOATE INJECTION [BLUEPOINT LABORATORIES]3Current NDC, 2 package rows20230915_f2d14406-2ad4-4c5b-9c24-a026f27b415d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1719803haloperidol decanoate 100 MG in 1 ML InjectionPSNf2d14406-2ad4-4c5b-9c24-a026f27b415d3
859871haloperidol decanoate 100 MG/ML Injectable SolutionPSNf2d14406-2ad4-4c5b-9c24-a026f27b415d3
1719862haloperidol decanoate 50 MG in 1 ML InjectionPSNf2d14406-2ad4-4c5b-9c24-a026f27b415d3
17198031 ML haloperidol decanoate 100 MG/ML InjectionSCDf2d14406-2ad4-4c5b-9c24-a026f27b415d3
17198621 ML haloperidol decanoate 50 MG/ML InjectionSCDf2d14406-2ad4-4c5b-9c24-a026f27b415d3
859871haloperidol decanoate 100 MG/ML Injectable SolutionSCDf2d14406-2ad4-4c5b-9c24-a026f27b415d3
859871haloperidol 100 MG/ML (as haloperidol decanoate) Injectable SolutionSYf2d14406-2ad4-4c5b-9c24-a026f27b415d3
1719803haloperidol decanoate 100 MG per 1 ML InjectionSYf2d14406-2ad4-4c5b-9c24-a026f27b415d3
1719862haloperidol decanoate 50 MG per 1 ML InjectionSYf2d14406-2ad4-4c5b-9c24-a026f27b415d3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68001-578-48680010578483 AMPULE in 1 CARTON (68001-578-48) / 1 mL in 1 AMPULE (68001-578-59) 3 ampule2023-09-15NoNoHistorical
68001-578-59680010578591 mL in 1 AMPULE1 mlHistorical