FDA.reportPublic FDA data

HALOPERIDOL DECANOATE

Product NDC
70069-381
11-digit product format
700690381
Labeler code
70069
Product ID
70069-381_f6d888a0-65a7-4073-8671-b00b4bfaff4c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
HALOPERIDOL DECANOATE
Dosage form
INJECTION
Route
INTRAMUSCULAR
Labeler
Somerset Therapeutics, LLC
Application
ANDA209101
Marketing category
ANDA
Marketing start
2019-04-04
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
Rxcui859867, 859871, 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
70069-381-01HALOPERIDOL DECANOATE1 in 1 CARTONINJECTION119
70069-381-01HALOPERIDOL DECANOATE1 mL in 1 VIAL, SINGLE-DOSEINJECTION119
70069-381-10HALOPERIDOL DECANOATE1 mL in 1 VIAL, SINGLE-DOSEINJECTION119
70069-381-10HALOPERIDOL DECANOATE10 in 1 CARTONINJECTION1019

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70069-381-01ML - Milliliter70069-3816b8294d0-65d6-4e13-b798-539a2d718a0612019-08-06
70069-381-10ML - Milliliter70069-381408d4cd8-0e86-41a8-8a93-bd7174d6381a12019-08-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70069-381HALOPERIDOL DECANOATE INJECTION [SOMERSET THERAPEUTICS, LLC]19Current NDC, Legacy NDC, 4 package rows20231219_f2bff27f-929f-4f7d-b3eb-084ebc2a885f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1719803haloperidol decanoate 100 MG in 1 ML InjectionPSNf2bff27f-929f-4f7d-b3eb-084ebc2a885f19
859871haloperidol decanoate 100 MG/ML Injectable SolutionPSNf2bff27f-929f-4f7d-b3eb-084ebc2a885f19
1719862haloperidol decanoate 50 MG in 1 ML InjectionPSNf2bff27f-929f-4f7d-b3eb-084ebc2a885f19
859867haloperidol decanoate 50 MG/ML Injectable SolutionPSNf2bff27f-929f-4f7d-b3eb-084ebc2a885f19
17198031 ML haloperidol decanoate 100 MG/ML InjectionSCDf2bff27f-929f-4f7d-b3eb-084ebc2a885f19
17198621 ML haloperidol decanoate 50 MG/ML InjectionSCDf2bff27f-929f-4f7d-b3eb-084ebc2a885f19
859871haloperidol decanoate 100 MG/ML Injectable SolutionSCDf2bff27f-929f-4f7d-b3eb-084ebc2a885f19
859867haloperidol decanoate 50 MG/ML Injectable SolutionSCDf2bff27f-929f-4f7d-b3eb-084ebc2a885f19
859871haloperidol 100 MG/ML (as haloperidol decanoate) Injectable SolutionSYf2bff27f-929f-4f7d-b3eb-084ebc2a885f19
859867haloperidol 50 MG/ML (as haloperidol decanoate) Injectable SolutionSYf2bff27f-929f-4f7d-b3eb-084ebc2a885f19
1719803haloperidol decanoate 100 MG per 1 ML InjectionSYf2bff27f-929f-4f7d-b3eb-084ebc2a885f19
1719862haloperidol decanoate 50 MG per 1 ML InjectionSYf2bff27f-929f-4f7d-b3eb-084ebc2a885f19

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70069-381-01700690381011 VIAL, SINGLE-DOSE in 1 CARTON (70069-381-01) / 1 mL in 1 VIAL, SINGLE-DOSE2019-10-040000-00-00NoNoCurrent
70069-381-107006903811010 VIAL, SINGLE-DOSE in 1 CARTON (70069-381-10) / 1 mL in 1 VIAL, SINGLE-DOSE2019-04-040000-00-00NoNoCurrent