FDA.reportPublic FDA data

Haloperidol decanoate

Product NDC
70710-1461
11-digit product format
707101461
Labeler code
70710
Product ID
70710-1461_f334b686-e82e-43d7-beb6-b1a7fb692af6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Haloperidol decanoate
Dosage form
INJECTION
Route
INTRAMUSCULAR
Labeler
Zydus Pharmaceuticals USA Inc.
Application
ANDA211180
Marketing category
ANDA
Marketing start
2019-11-14
Substance
HALOPERIDOL DECANOATE
Active strength
50 mg/mL
Pharmacologic classes
Typical Antipsychotic [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Haloperidol decanoate
Listing expiration
2027-12-31

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
70710-1461-6Haloperidol decanoate10 in 1 CARTONINJECTION109
70710-1461-6Haloperidol decanoate1 mL in 1 VIAL, SINGLE-DOSEINJECTION19
70710-1461-9Haloperidol decanoate1 mL in 1 VIAL, SINGLE-DOSEINJECTION19
70710-1461-9Haloperidol decanoate3 in 1 CARTONINJECTION39

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70710-1461-1ML - Milliliter70710-1461a31d5091-85ad-4bac-9c74-69fcd6692c0412021-06-02
70710-1461-6ML - Milliliter70710-1461aff1cd36-3390-43cb-a891-cf6c74083f4712020-02-13
70710-1461-9ML - Milliliter70710-146127d72f6f-bf61-4e08-8a3f-5b9ec3130aaa12020-02-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70710-1461HALOPERIDOL DECANOATE INJECTION [ZYDUS PHARMACEUTICALS USA INC.]8Current NDC, Legacy NDC, 4 package rows20250215_6d2d7612-ad47-4ee7-a42c-945c976d947b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1719803haloperidol decanoate 100 MG in 1 ML InjectionPSN6d2d7612-ad47-4ee7-a42c-945c976d947b9
859871haloperidol decanoate 100 MG/ML Injectable SolutionPSN6d2d7612-ad47-4ee7-a42c-945c976d947b9
1719862haloperidol decanoate 50 MG in 1 ML InjectionPSN6d2d7612-ad47-4ee7-a42c-945c976d947b9
859867haloperidol decanoate 50 MG/ML Injectable SolutionPSN6d2d7612-ad47-4ee7-a42c-945c976d947b9
17198031 ML haloperidol decanoate 100 MG/ML InjectionSCD6d2d7612-ad47-4ee7-a42c-945c976d947b9
17198621 ML haloperidol decanoate 50 MG/ML InjectionSCD6d2d7612-ad47-4ee7-a42c-945c976d947b9
859871haloperidol decanoate 100 MG/ML Injectable SolutionSCD6d2d7612-ad47-4ee7-a42c-945c976d947b9
859867haloperidol decanoate 50 MG/ML Injectable SolutionSCD6d2d7612-ad47-4ee7-a42c-945c976d947b9
859871haloperidol 100 MG/ML (as haloperidol decanoate) Injectable SolutionSY6d2d7612-ad47-4ee7-a42c-945c976d947b9
859867haloperidol 50 MG/ML (as haloperidol decanoate) Injectable SolutionSY6d2d7612-ad47-4ee7-a42c-945c976d947b9
1719803haloperidol decanoate 100 MG per 1 ML InjectionSY6d2d7612-ad47-4ee7-a42c-945c976d947b9
1719862haloperidol decanoate 50 MG per 1 ML InjectionSY6d2d7612-ad47-4ee7-a42c-945c976d947b9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70710-1461-67071014610610 VIAL, SINGLE-DOSE in 1 CARTON (70710-1461-6) / 1 mL in 1 VIAL, SINGLE-DOSE2019-11-140000-00-00NoNoCurrent
70710-1461-9707101461093 VIAL, SINGLE-DOSE in 1 CARTON (70710-1461-9) / 1 mL in 1 VIAL, SINGLE-DOSE2019-11-140000-00-00NoNoCurrent