Haldol Decanoate

Product NDC
50458-253
11-digit product format
504580253
Labeler code
50458
Product ID
50458-253_43588a6b-8b38-dcaa-e063-6294a90a1666
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Haloperidol Decanoate
Dosage form
INJECTION
Route
INTRAMUSCULAR
Labeler
Janssen Pharmaceuticals, Inc.
Application
NDA018701
Marketing category
NDA
Marketing start
1986-01-14
Marketing end
2027-05-31
Substance
HALOPERIDOL DECANOATE
Active strength
50 mg/mL
Pharmacologic classes
Typical Antipsychotic [EPC]
NDC exclude flag
No
Current FDA listing
Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage50458-25350458-253-01DDiscontinued by firm2026-08-17

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N018701-001HALDOLHALOPERIDOL DECANOATEEQ 50MG BASE/MLINJECTABLE / INJECTIONRLD1986-01-14
N018701-002HALDOLHALOPERIDOL DECANOATEEQ 100MG BASE/MLINJECTABLE / INJECTIONRLD1997-01-31

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07N018701-001HALDOLEQ 50MG BASE/MLINJECTABLE / INJECTIONRLD1986-01-14caaa826d4ba7…
2026-08-18 06:07:402026-07N018701-002HALDOLEQ 100MG BASE/MLINJECTABLE / INJECTIONRLD1997-01-31caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N018701-001HALDOLEQ 50MG BASE/MLINJECTABLE / INJECTIONRLD1986-01-14011fe1cb6892…
2026-02-19 14:30 UTC2026-02N018701-002HALDOLEQ 100MG BASE/MLINJECTABLE / INJECTIONRLD1997-01-31011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N018701-001HALDOLEQ 50MG BASE/MLINJECTABLE / INJECTIONRLD1986-01-1431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N018701-002HALDOLEQ 100MG BASE/MLINJECTABLE / INJECTIONRLD1997-01-3131067a03dcf5…
2025-08-23 18:47 UTC2025-08N018701-001HALDOLEQ 50MG BASE/MLINJECTABLE / INJECTIONAORLD, RS1986-01-146a471c1ec25d…
2025-08-23 18:47 UTC2025-08N018701-002HALDOLEQ 100MG BASE/MLINJECTABLE / INJECTIONAORLD, RS1997-01-316a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N018701-001HALDOLEQ 50MG BASE/MLINJECTABLE / INJECTIONAORLD, RS1986-01-14fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N018701-002HALDOLEQ 100MG BASE/MLINJECTABLE / INJECTIONAORLD, RS1997-01-31fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N018701-001HALDOLEQ 50MG BASE/MLINJECTABLE / INJECTIONAORLD, RS1986-01-14b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N018701-002HALDOLEQ 100MG BASE/MLINJECTABLE / INJECTIONAORLD, RS1997-01-31b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N018701-001HALDOLEQ 50MG BASE/MLINJECTABLE / INJECTIONAORLD, RS1986-01-1403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N018701-002HALDOLEQ 100MG BASE/MLINJECTABLE / INJECTIONAORLD, RS1997-01-3103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N018701-001HALDOLEQ 50MG BASE/MLINJECTABLE / INJECTIONAORLD, RS1986-01-142680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N018701-002HALDOLEQ 100MG BASE/MLINJECTABLE / INJECTIONAORLD, RS1997-01-312680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N018701-001HALDOLEQ 50MG BASE/MLINJECTABLE / INJECTIONAORLD, RS1986-01-145bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N018701-002HALDOLEQ 100MG BASE/MLINJECTABLE / INJECTIONAORLD, RS1997-01-315bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N018701-001HALDOLEQ 50MG BASE/MLINJECTABLE / INJECTIONAORLD, RS1986-01-14d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N018701-002HALDOLEQ 100MG BASE/MLINJECTABLE / INJECTIONAORLD, RS1997-01-31d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N018701-001HALDOLEQ 50MG BASE/MLINJECTABLE / INJECTIONAORLD, RS1986-01-14d06236e962d9…
2024-10-29 15:01 UTC2024-10N018701-002HALDOLEQ 100MG BASE/MLINJECTABLE / INJECTIONAORLD, RS1997-01-31d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N018701-001HALDOLEQ 50MG BASE/MLINJECTABLE / INJECTIONAORLD, RS1986-01-1479d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N018701-002HALDOLEQ 100MG BASE/MLINJECTABLE / INJECTIONAORLD, RS1997-01-3179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N018701-001HALDOLEQ 50MG BASE/MLINJECTABLE / INJECTIONAORLD, RS1986-01-14301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N018701-002HALDOLEQ 100MG BASE/MLINJECTABLE / INJECTIONAORLD, RS1997-01-31301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N018701-001HALDOLEQ 50MG BASE/MLINJECTABLE / INJECTIONAORLD, RS1986-01-141e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N018701-002HALDOLEQ 100MG BASE/MLINJECTABLE / INJECTIONAORLD, RS1997-01-311e350fbaab3a…
2024-05-31 18:47 UTC2024-05N018701-001HALDOLEQ 50MG BASE/MLINJECTABLE / INJECTIONAORLD, RS1986-01-148072bd15b7f6…
2024-05-31 18:47 UTC2024-05N018701-002HALDOLEQ 100MG BASE/MLINJECTABLE / INJECTIONAORLD, RS1997-01-318072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N018701-001HALDOLEQ 50MG BASE/MLINJECTABLE / INJECTIONAORLD, RS1986-01-145c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N018701-002HALDOLEQ 100MG BASE/MLINJECTABLE / INJECTIONAORLD, RS1997-01-315c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N018701-001HALDOLEQ 50MG BASE/MLINJECTABLE / INJECTIONAORLD, RS1986-01-145d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N018701-002HALDOLEQ 100MG BASE/MLINJECTABLE / INJECTIONAORLD, RS1997-01-315d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N018701-001HALDOLEQ 50MG BASE/MLINJECTABLE / INJECTIONAORLD, RS1986-01-144b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N018701-002HALDOLEQ 100MG BASE/MLINJECTABLE / INJECTIONAORLD, RS1997-01-314b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N018701-001HALDOLEQ 50MG BASE/MLINJECTABLE / INJECTIONAORLD, RS1986-01-1474a2ff9319b5…
2019-12-13 00:20 UTC2019-12N018701-002HALDOLEQ 100MG BASE/MLINJECTABLE / INJECTIONAORLD, RS1997-01-3174a2ff9319b5…
2022-03-09 01:35 UTC2022-03N018701-001HALDOLEQ 50MG BASE/MLINJECTABLE / INJECTIONAORLD, RS1986-01-14bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N018701-002HALDOLEQ 100MG BASE/MLINJECTABLE / INJECTIONAORLD, RS1997-01-31bb7c543d1eb4…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 76 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2025-08-23 18:47 UTC2025-08N018701-001AO16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N018701-002AO16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N018701-001AO1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N018701-002AO1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N018701-001AO1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N018701-002AO1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N018701-001AO103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N018701-002AO103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N018701-001AO12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N018701-002AO12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N018701-001AO15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N018701-002AO15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N018701-001AO1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N018701-002AO1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N018701-001AO1d06236e962d9…
2024-10-29 15:01 UTC2024-10N018701-002AO1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N018701-001AO179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N018701-002AO179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N018701-001AO1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N018701-002AO1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N018701-001AO11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N018701-002AO11e350fbaab3a…
2024-05-31 18:47 UTC2024-05N018701-001AO18072bd15b7f6…
2024-05-31 18:47 UTC2024-05N018701-002AO18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N018701-001AO15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N018701-002AO15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N018701-001AO15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N018701-002AO15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N018701-001AO14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N018701-002AO14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N018701-001AO174a2ff9319b5…
2019-12-13 00:20 UTC2019-12N018701-002AO174a2ff9319b5…
2022-03-09 01:35 UTC2022-03N018701-001AO1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N018701-002AO1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N018701-001AO1782e0a99824c…
2021-12-28 21:50 UTC2021-12N018701-002AO1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N018701-001AO187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N018701-002AO187673890dc5c…
2021-03-12 10:30 UTC2021-03N018701-001AO15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03N018701-002AO15aa47cf7b7d7…

Additional Listing Data#

Finished product
Yes
Brand name base
Haldol Decanoate

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HALOPERIDOL DECANOATE50 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
AC20PJ4101Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1719803Internal RxNorm lookup
1719847Internal RxNorm lookup
1719862Internal RxNorm lookup
1720026Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
af0159a8-dff5-449a-aa2b-a0c430081e21Available on FDA.report

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
50458-253-01Haldol Decanoate1 mL in 1 AMPULEINJECTION125
50458-253-01Haldol Decanoate10 in 1 BOXINJECTION1025
50458-253-03Haldol Decanoate3 in 1 BOXINJECTION325
50458-253-03Haldol Decanoate1 mL in 1 AMPULEINJECTION125

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50458-253-03ML - Milliliter50458-25367fb19f0-d329-4540-875c-0db335a2b23412012-07-24

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50458-253HALDOL DECANOATE (HALOPERIDOL DECANOATE) INJECTION [JANSSEN PHARMACEUTICALS, INC.]24Current NDC, Legacy NDC, 4 package rows20250131_af0159a8-dff5-449a-aa2b-a0c430081e21.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Haldol DecanoateHALOPERIDOL DECANOATEJanssen Pharmaceuticals, Inc.af0159a8-dff5-449a-aa2b-a0c430081e212025-11-11Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 018701
application number: NDA018701
ndc (product): 50458-253
Haloperidol DecanoateHALOPERIDOL DECANOATEPatriot Pharmaceuticals LLC9f0f42a8-5f7c-4be7-93ef-3ec225502cc62025-02-19Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 018701
application number: NDA018701

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1719847Haldol Decanoate 100 MG in 1 ML InjectionPSNaf0159a8-dff5-449a-aa2b-a0c430081e2125
1720026Haldol Decanoate 50 MG in 1 ML InjectionPSNaf0159a8-dff5-449a-aa2b-a0c430081e2125
1719803haloperidol decanoate 100 MG in 1 ML InjectionPSNaf0159a8-dff5-449a-aa2b-a0c430081e2125
1719862haloperidol decanoate 50 MG in 1 ML InjectionPSNaf0159a8-dff5-449a-aa2b-a0c430081e2125
17198471 ML haloperidol decanoate 100 MG/ML Injection [Haldol]SBDaf0159a8-dff5-449a-aa2b-a0c430081e2125
17200261 ML haloperidol decanoate 50 MG/ML Injection [Haldol]SBDaf0159a8-dff5-449a-aa2b-a0c430081e2125
17198031 ML haloperidol decanoate 100 MG/ML InjectionSCDaf0159a8-dff5-449a-aa2b-a0c430081e2125
17198621 ML haloperidol decanoate 50 MG/ML InjectionSCDaf0159a8-dff5-449a-aa2b-a0c430081e2125
17198471 ML Haldol 100 MG/ML InjectionSYaf0159a8-dff5-449a-aa2b-a0c430081e2125
17200261 ML Haldol 50 MG/ML InjectionSYaf0159a8-dff5-449a-aa2b-a0c430081e2125
1719847Haldol Decanoate 100 MG per 1 ML InjectionSYaf0159a8-dff5-449a-aa2b-a0c430081e2125
1720026Haldol Decanoate 50 MG per 1 ML InjectionSYaf0159a8-dff5-449a-aa2b-a0c430081e2125
1719803haloperidol decanoate 100 MG per 1 ML InjectionSYaf0159a8-dff5-449a-aa2b-a0c430081e2125
1719862haloperidol decanoate 50 MG per 1 ML InjectionSYaf0159a8-dff5-449a-aa2b-a0c430081e2125

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50458-253-01504580253011 mL in 1 AMPULE1 mlHistorical
50458-253-03504580253033 AMPULE in 1 BOX (50458-253-03) / 1 mL in 1 AMPULE3 ampule1986-01-142027-05-31NoNoCurrent