FDA.reportPublic FDA data

Haloperidol Decanoate

Product NDC
64725-0471
11-digit product format
647250471
Labeler code
64725
Product ID
64725-0471_b948d2eb-c7fa-49f2-bd68-18482f85dc72
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
HALOPERIDOL DECANOATE
Dosage form
INJECTION
Route
INTRAMUSCULAR
Labeler
TYA Pharmaceuticals
Application
ANDA074893
Marketing category
ANDA
Marketing start
2000-07-12
Marketing end
0000-00-00
Substance
HALOPERIDOL DECANOATE
Active strength
100 mg/mL
Pharmacologic classes
Typical Antipsychotic [EPC]
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

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
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
64725-0471-12020-01-31C16284748780-19d75b9d0-bd40-f424-e053-dadaa90a57ceHaloperidol Decanoate Injection

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
64725-0471-1Haloperidol Decanoate1 mL in 1 CARTONINJECTION12

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
HALOPERIDOL DECANOATEACTIVE INGREDIENTAC20PJ4101HALOPERIDOL DECANOATE INJECTION [TYA PHARMACEUTICALS]2
HALOPERIDOLACTIVE MOIETYJ6292F8L3DHALOPERIDOL DECANOATE INJECTION [TYA PHARMACEUTICALS]2
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBHHALOPERIDOL DECANOATE INJECTION [TYA PHARMACEUTICALS]2
SESAME OILINACTIVE INGREDIENTQX10HYY4QVHALOPERIDOL DECANOATE INJECTION [TYA PHARMACEUTICALS]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64725-0471HALOPERIDOL DECANOATE INJECTION [TYA PHARMACEUTICALS]2Legacy NDC, 1 package rows20141031_3b2b3ba9-4c4e-489d-b836-e2a4a9ff8502.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1719803haloperidol decanoate 100 MG in 1 ML InjectionPSN3b2b3ba9-4c4e-489d-b836-e2a4a9ff85022
17198031 ML haloperidol decanoate 100 MG/ML InjectionSCD3b2b3ba9-4c4e-489d-b836-e2a4a9ff85022
1719803haloperidol decanoate 100 MG per 1 ML InjectionSY3b2b3ba9-4c4e-489d-b836-e2a4a9ff85022

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
64725-0471-1647250471011 mL in 1 CARTON1 mlHistorical