Haloperidol decanoate

Product NDC
72785-0005
11-digit product format
727850005
Labeler code
72785
Product ID
72785-0005_ed63a7e6-a769-4c05-8e33-d724debffa7e
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
Marketing end
0000-00-00
Substance
HALOPERIDOL DECANOATE
Active strength
50 mg/mL
Pharmacologic classes
Typical Antipsychotic [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

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 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct72785-0005DDiscontinued by firm2026-08-17
excluded packagepackage72785-000572785-0005-1DDiscontinued by firm2026-08-17
excluded packagepackage72785-000572785-0005-5DDiscontinued 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 · 36 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage72785-0005-1d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage72785-0005-5d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage72785-0005-1f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage72785-0005-5f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage72785-0005-12ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage72785-0005-52ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage72785-0005-1a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage72785-0005-5a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage72785-0005-1cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage72785-0005-5cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage72785-0005-1cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage72785-0005-5cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage72785-0005-1302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage72785-0005-5302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage72785-0005-1ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage72785-0005-5ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage72785-0005-10efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage72785-0005-50efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage72785-0005-1ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage72785-0005-5ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage72785-0005-1367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage72785-0005-5367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage72785-0005-1557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage72785-0005-5557ba5c1ecfa…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
A211180-001HALOPERIDOL DECANOATEHALOPERIDOL DECANOATEEQ 50MG BASE/MLINJECTABLE / INJECTIONAO2019-10-22
A211180-002HALOPERIDOL DECANOATEHALOPERIDOL DECANOATEEQ 100MG BASE/MLINJECTABLE / INJECTIONAO2019-10-22

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A211180-001AO
A211180-002AO

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 2 · 80 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A211180-001HALOPERIDOL DECANOATEEQ 50MG BASE/MLINJECTABLE / INJECTIONAO2019-10-22caaa826d4ba7…
2026-08-18 06:07:402026-07A211180-002HALOPERIDOL DECANOATEEQ 100MG BASE/MLINJECTABLE / INJECTIONAO2019-10-22caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A211180-001HALOPERIDOL DECANOATEEQ 50MG BASE/MLINJECTABLE / INJECTIONAO2019-10-22011fe1cb6892…
2026-02-19 14:30 UTC2026-02A211180-002HALOPERIDOL DECANOATEEQ 100MG BASE/MLINJECTABLE / INJECTIONAO2019-10-22011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211180-001HALOPERIDOL DECANOATEEQ 50MG BASE/MLINJECTABLE / INJECTIONAO2019-10-2231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211180-002HALOPERIDOL DECANOATEEQ 100MG BASE/MLINJECTABLE / INJECTIONAO2019-10-2231067a03dcf5…
2025-08-23 18:47 UTC2025-08A211180-001HALOPERIDOL DECANOATEEQ 50MG BASE/MLINJECTABLE / INJECTIONAO2019-10-226a471c1ec25d…
2025-08-23 18:47 UTC2025-08A211180-002HALOPERIDOL DECANOATEEQ 100MG BASE/MLINJECTABLE / INJECTIONAO2019-10-226a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211180-001HALOPERIDOL DECANOATEEQ 50MG BASE/MLINJECTABLE / INJECTIONAO2019-10-22fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211180-002HALOPERIDOL DECANOATEEQ 100MG BASE/MLINJECTABLE / INJECTIONAO2019-10-22fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211180-001HALOPERIDOL DECANOATEEQ 50MG BASE/MLINJECTABLE / INJECTIONAO2019-10-22b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211180-002HALOPERIDOL DECANOATEEQ 100MG BASE/MLINJECTABLE / INJECTIONAO2019-10-22b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211180-001HALOPERIDOL DECANOATEEQ 50MG BASE/MLINJECTABLE / INJECTIONAO2019-10-2203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211180-002HALOPERIDOL DECANOATEEQ 100MG BASE/MLINJECTABLE / INJECTIONAO2019-10-2203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211180-001HALOPERIDOL DECANOATEEQ 50MG BASE/MLINJECTABLE / INJECTIONAO2019-10-222680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211180-002HALOPERIDOL DECANOATEEQ 100MG BASE/MLINJECTABLE / INJECTIONAO2019-10-222680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211180-001HALOPERIDOL DECANOATEEQ 50MG BASE/MLINJECTABLE / INJECTIONAO2019-10-225bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211180-002HALOPERIDOL DECANOATEEQ 100MG BASE/MLINJECTABLE / INJECTIONAO2019-10-225bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A211180-001HALOPERIDOL DECANOATEEQ 50MG BASE/MLINJECTABLE / INJECTIONAO2019-10-22d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A211180-002HALOPERIDOL DECANOATEEQ 100MG BASE/MLINJECTABLE / INJECTIONAO2019-10-22d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A211180-001HALOPERIDOL DECANOATEEQ 50MG BASE/MLINJECTABLE / INJECTIONAO2019-10-22d06236e962d9…
2024-10-29 15:01 UTC2024-10A211180-002HALOPERIDOL DECANOATEEQ 100MG BASE/MLINJECTABLE / INJECTIONAO2019-10-22d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A211180-001HALOPERIDOL DECANOATEEQ 50MG BASE/MLINJECTABLE / INJECTIONAO2019-10-2279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A211180-002HALOPERIDOL DECANOATEEQ 100MG BASE/MLINJECTABLE / INJECTIONAO2019-10-2279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A211180-001HALOPERIDOL DECANOATEEQ 50MG BASE/MLINJECTABLE / INJECTIONAO2019-10-22301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A211180-002HALOPERIDOL DECANOATEEQ 100MG BASE/MLINJECTABLE / INJECTIONAO2019-10-22301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A211180-001HALOPERIDOL DECANOATEEQ 50MG BASE/MLINJECTABLE / INJECTIONAO2019-10-221e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A211180-002HALOPERIDOL DECANOATEEQ 100MG BASE/MLINJECTABLE / INJECTIONAO2019-10-221e350fbaab3a…
2024-05-31 18:47 UTC2024-05A211180-001HALOPERIDOL DECANOATEEQ 50MG BASE/MLINJECTABLE / INJECTIONAO2019-10-228072bd15b7f6…
2024-05-31 18:47 UTC2024-05A211180-002HALOPERIDOL DECANOATEEQ 100MG BASE/MLINJECTABLE / INJECTIONAO2019-10-228072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A211180-001HALOPERIDOL DECANOATEEQ 50MG BASE/MLINJECTABLE / INJECTIONAO2019-10-225c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A211180-002HALOPERIDOL DECANOATEEQ 100MG BASE/MLINJECTABLE / INJECTIONAO2019-10-225c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A211180-001HALOPERIDOL DECANOATEEQ 50MG BASE/MLINJECTABLE / INJECTIONAO2019-10-225d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A211180-002HALOPERIDOL DECANOATEEQ 100MG BASE/MLINJECTABLE / INJECTIONAO2019-10-225d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A211180-001HALOPERIDOL DECANOATEEQ 50MG BASE/MLINJECTABLE / INJECTIONAO2019-10-224b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A211180-002HALOPERIDOL DECANOATEEQ 100MG BASE/MLINJECTABLE / INJECTIONAO2019-10-224b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A211180-001HALOPERIDOL DECANOATEEQ 50MG BASE/MLINJECTABLE / INJECTIONAO2019-10-2274a2ff9319b5…
2019-12-13 00:20 UTC2019-12A211180-002HALOPERIDOL DECANOATEEQ 100MG BASE/MLINJECTABLE / INJECTIONAO2019-10-2274a2ff9319b5…
2022-03-09 01:35 UTC2022-03A211180-001HALOPERIDOL DECANOATEEQ 50MG BASE/MLINJECTABLE / INJECTIONAO2019-10-22bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A211180-002HALOPERIDOL DECANOATEEQ 100MG BASE/MLINJECTABLE / INJECTIONAO2019-10-22bb7c543d1eb4…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 80 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A211180-001AO1caaa826d4ba7…
2026-08-18 06:07:402026-07A211180-002AO1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A211180-001AO1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A211180-002AO1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211180-001AO131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211180-002AO131067a03dcf5…
2025-08-23 18:47 UTC2025-08A211180-001AO16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A211180-002AO16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211180-001AO1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211180-002AO1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211180-001AO1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211180-002AO1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211180-001AO103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211180-002AO103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211180-001AO12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211180-002AO12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211180-001AO15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211180-002AO15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A211180-001AO1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A211180-002AO1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A211180-001AO1d06236e962d9…
2024-10-29 15:01 UTC2024-10A211180-002AO1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A211180-001AO179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A211180-002AO179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A211180-001AO1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A211180-002AO1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A211180-001AO11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A211180-002AO11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A211180-001AO18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A211180-002AO18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A211180-001AO15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A211180-002AO15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A211180-001AO15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A211180-002AO15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A211180-001AO14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A211180-002AO14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A211180-001AO174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A211180-002AO174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A211180-001AO1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A211180-002AO1bb7c543d1eb4…

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 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Haloperidol decanoateHALOPERIDOL DECANOATEZydus Pharmaceuticals USA Inc.6d2d7612-ad47-4ee7-a42c-945c976d947b2026-07-10Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211180
application number: ANDA211180
Haloperidol decanoateHALOPERIDOL DECANOATEBluePoint Laboratories3d011250-a517-4c27-8ce3-d59d441ea61c2026-03-24Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211180
application number: ANDA211180
Haloperidol decanoateHALOPERIDOL DECANOATEZydus Lifesciences Limitedd21796e5-9f29-4c0a-8eed-70aeb9f0e5e92023-09-01Exact identifier
application applno (ANDA): 211180
application number: ANDA211180

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
72785-0005-1727850005011 VIAL, MULTI-DOSE in 1 CARTON (72785-0005-1) > 5 mL in 1 VIAL, MULTI-DOSE2019-11-140000-00-00NoNoCurrent
72785-0005-5727850005055 VIAL, MULTI-DOSE in 1 CARTON (72785-0005-5) > 5 mL in 1 VIAL, MULTI-DOSE2019-11-140000-00-00NoNoCurrent