FDA.reportPublic FDA data

Haloperidol decanoate

Product NDC
70771-1853
11-digit product format
707711853
Labeler code
70771
Product ID
70771-1853_04562fb6-450e-4345-ac35-6bc8c940682a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Haloperidol decanoate
Dosage form
INJECTION
Route
INTRAMUSCULAR
Labeler
Zydus Lifesciences Limited
Application
ANDA211180
Marketing category
ANDA
Marketing start
2019-11-14
Substance
HALOPERIDOL DECANOATE
Active strength
100 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 DECANOATE100 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
70771-1853-1Haloperidol decanoate1 in 1 CARTONINJECTION11
70771-1853-1Haloperidol decanoate1 mL in 1 VIAL, SINGLE-DOSEINJECTION11
70771-1853-5Haloperidol decanoate5 in 1 CARTONINJECTION51
70771-1853-5Haloperidol decanoate1 mL in 1 VIAL, SINGLE-DOSEINJECTION11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70771-1853HALOPERIDOL DECANOATE INJECTION [ZYDUS LIFESCIENCES LIMITED]1Current NDC, 4 package rows20230902_d21796e5-9f29-4c0a-8eed-70aeb9f0e5e9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1719803haloperidol decanoate 100 MG in 1 ML InjectionPSNd21796e5-9f29-4c0a-8eed-70aeb9f0e5e91
859871haloperidol decanoate 100 MG/ML Injectable SolutionPSNd21796e5-9f29-4c0a-8eed-70aeb9f0e5e91
1719862haloperidol decanoate 50 MG in 1 ML InjectionPSNd21796e5-9f29-4c0a-8eed-70aeb9f0e5e91
859867haloperidol decanoate 50 MG/ML Injectable SolutionPSNd21796e5-9f29-4c0a-8eed-70aeb9f0e5e91
17198031 ML haloperidol decanoate 100 MG/ML InjectionSCDd21796e5-9f29-4c0a-8eed-70aeb9f0e5e91
17198621 ML haloperidol decanoate 50 MG/ML InjectionSCDd21796e5-9f29-4c0a-8eed-70aeb9f0e5e91
859871haloperidol decanoate 100 MG/ML Injectable SolutionSCDd21796e5-9f29-4c0a-8eed-70aeb9f0e5e91
859867haloperidol decanoate 50 MG/ML Injectable SolutionSCDd21796e5-9f29-4c0a-8eed-70aeb9f0e5e91
859871haloperidol 100 MG/ML (as haloperidol decanoate) Injectable SolutionSYd21796e5-9f29-4c0a-8eed-70aeb9f0e5e91
859867haloperidol 50 MG/ML (as haloperidol decanoate) Injectable SolutionSYd21796e5-9f29-4c0a-8eed-70aeb9f0e5e91
1719803haloperidol decanoate 100 MG per 1 ML InjectionSYd21796e5-9f29-4c0a-8eed-70aeb9f0e5e91
1719862haloperidol decanoate 50 MG per 1 ML InjectionSYd21796e5-9f29-4c0a-8eed-70aeb9f0e5e91

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
70771-1853-1707711853011 VIAL, SINGLE-DOSE in 1 CARTON (70771-1853-1) / 1 mL in 1 VIAL, SINGLE-DOSE2019-11-14NoNoHistorical
70771-1853-5707711853055 VIAL, SINGLE-DOSE in 1 CARTON (70771-1853-5) / 1 mL in 1 VIAL, SINGLE-DOSE2019-11-14NoNoHistorical