Home DailyMed d21796e5-9f29-4c0a-8eed-70aeb9f0e5e9 Haloperidol Decanoate Injection For Intramuscular Injection Only Drug label information. FDA.report displays public Structured Product Labeling data from DailyMed and legacy FDA.report DailyMed cache rows. This page is not medical advice, prescribing advice, or a substitute for the official label reviewed by a qualified healthcare professional. Labeling can change; when a current hydrated DailyMed SPL record is available, FDA.report shows that newer record before legacy cached files.
Manufacturer Zydus Lifesciences Limited
Effective date 2023-09-01
Label type HUMAN PRESCRIPTION DRUG LABEL
Version 1
Source full-release
Hydrated at 2026-05-31 20:52:47 Label at a glance# Product Haloperidol decanoate
Active ingredient HALOPERIDOL DECANOATE
Label structure 1 sections
DailyMed RxNorm Mappings# RxCUI, RxNorm string, TTY table RxCUI RxNorm string TTY SPL version 1719803 haloperidol decanoate 100 MG in 1 ML Injection PSN 1 859871 haloperidol decanoate 100 MG/ML Injectable Solution PSN 1 1719862 haloperidol decanoate 50 MG in 1 ML Injection PSN 1 859867 haloperidol decanoate 50 MG/ML Injectable Solution PSN 1 1719803 1 ML haloperidol decanoate 100 MG/ML Injection SCD 1 1719862 1 ML haloperidol decanoate 50 MG/ML Injection SCD 1 859871 haloperidol decanoate 100 MG/ML Injectable Solution SCD 1 859867 haloperidol decanoate 50 MG/ML Injectable Solution SCD 1 859871 haloperidol 100 MG/ML (as haloperidol decanoate) Injectable Solution SY 1 859867 haloperidol 50 MG/ML (as haloperidol decanoate) Injectable Solution SY 1 1719803 haloperidol decanoate 100 MG per 1 ML Injection SY 1 1719862 haloperidol decanoate 50 MG per 1 ML Injection SY 1
DailyMed Pharmacologic Classes# DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 70771-1851-6 Haloperidol decanoate 10 in 1 CARTON INJECTION 10 1 70771-1851-6 Haloperidol decanoate 1 mL in 1 VIAL, SINGLE-DOSE INJECTION 1 1 70771-1851-9 Haloperidol decanoate 1 mL in 1 VIAL, SINGLE-DOSE INJECTION 1 1 70771-1851-9 Haloperidol decanoate 3 in 1 CARTON INJECTION 3 1 70771-1852-1 Haloperidol decanoate 1 in 1 CARTON INJECTION 1 1 70771-1852-1 Haloperidol decanoate 5 mL in 1 VIAL, MULTI-DOSE INJECTION 5 1 70771-1852-5 Haloperidol decanoate 5 mL in 1 VIAL, MULTI-DOSE INJECTION 5 1 70771-1852-5 Haloperidol decanoate 5 in 1 CARTON INJECTION 5 1 70771-1853-1 Haloperidol decanoate 1 in 1 CARTON INJECTION 1 1 70771-1853-1 Haloperidol decanoate 1 mL in 1 VIAL, SINGLE-DOSE INJECTION 1 1 70771-1853-5 Haloperidol decanoate 5 in 1 CARTON INJECTION 5 1 70771-1853-5 Haloperidol decanoate 1 mL in 1 VIAL, SINGLE-DOSE INJECTION 1 1 70771-1854-1 Haloperidol decanoate 5 mL in 1 VIAL, MULTI-DOSE INJECTION 5 1 70771-1854-1 Haloperidol decanoate 1 in 1 CARTON INJECTION 1 1 70771-1854-5 Haloperidol decanoate 5 mL in 1 VIAL, MULTI-DOSE INJECTION 5 1 70771-1854-5 Haloperidol decanoate 5 in 1 CARTON INJECTION 5 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70771-1851 HALOPERIDOL DECANOATE INJECTION [ZYDUS LIFESCIENCES LIMITED] 1 Current NDC, 4 package rows 20230902_d21796e5-9f29-4c0a-8eed-70aeb9f0e5e9.zip 70771-1852 HALOPERIDOL DECANOATE INJECTION [ZYDUS LIFESCIENCES LIMITED] 1 Current NDC, 4 package rows 20230902_d21796e5-9f29-4c0a-8eed-70aeb9f0e5e9.zip 70771-1853 HALOPERIDOL DECANOATE INJECTION [ZYDUS LIFESCIENCES LIMITED] 1 Current NDC, 4 package rows 20230902_d21796e5-9f29-4c0a-8eed-70aeb9f0e5e9.zip 70771-1854 HALOPERIDOL DECANOATE INJECTION [ZYDUS LIFESCIENCES LIMITED] 1 Current NDC, 4 package rows 20230902_d21796e5-9f29-4c0a-8eed-70aeb9f0e5e9.zip
Products# Every source-derived product name is available through these pages.
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Haloperidol decanoate HALOPERIDOL SESAME OIL BENZYL ALCOHOL Ingredients# Every source-derived ingredient row is available through these pages.
DailyMed ingredient rows page 1 of 1 · 12 matching rows.
Orange Book application contexts# All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.
Orange Book application contexts page 1 of 1 · 1 matching rows.
Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A211180-001 HALOPERIDOL DECANOATE HALOPERIDOL DECANOATE EQ 50MG BASE/ML INJECTABLE / INJECTION AO 2019-10-22 A211180-002 HALOPERIDOL DECANOATE HALOPERIDOL DECANOATE EQ 100MG BASE/ML INJECTABLE / INJECTION AO 2019-10-22
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-10-15 13:18:30 2026-09 A211180-001 HALOPERIDOL DECANOATE EQ 50MG BASE/ML INJECTABLE / INJECTION AO 2019-10-22 c2088c7a36db…2026-10-15 13:18:30 2026-09 A211180-002 HALOPERIDOL DECANOATE EQ 100MG BASE/ML INJECTABLE / INJECTION AO 2019-10-22 c2088c7a36db…2026-09-14 22:38:34 2026-08 A211180-001 HALOPERIDOL DECANOATE EQ 50MG BASE/ML INJECTABLE / INJECTION AO 2019-10-22 84e616aacf4f…2026-09-14 22:38:34 2026-08 A211180-002 HALOPERIDOL DECANOATE EQ 100MG BASE/ML INJECTABLE / INJECTION AO 2019-10-22 84e616aacf4f…2026-08-18 06:07:40 2026-07 A211180-001 HALOPERIDOL DECANOATE EQ 50MG BASE/ML INJECTABLE / INJECTION AO 2019-10-22 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A211180-002 HALOPERIDOL DECANOATE EQ 100MG BASE/ML INJECTABLE / INJECTION AO 2019-10-22 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A211180-001 HALOPERIDOL DECANOATE EQ 50MG BASE/ML INJECTABLE / INJECTION AO 2019-10-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A211180-002 HALOPERIDOL DECANOATE EQ 100MG BASE/ML INJECTABLE / INJECTION AO 2019-10-22 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211180-001 HALOPERIDOL DECANOATE EQ 50MG BASE/ML INJECTABLE / INJECTION AO 2019-10-22 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211180-002 HALOPERIDOL DECANOATE EQ 100MG BASE/ML INJECTABLE / INJECTION AO 2019-10-22 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A211180-001 HALOPERIDOL DECANOATE EQ 50MG BASE/ML INJECTABLE / INJECTION AO 2019-10-22 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A211180-002 HALOPERIDOL DECANOATE EQ 100MG BASE/ML INJECTABLE / INJECTION AO 2019-10-22 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211180-001 HALOPERIDOL DECANOATE EQ 50MG BASE/ML INJECTABLE / INJECTION AO 2019-10-22 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211180-002 HALOPERIDOL DECANOATE EQ 100MG BASE/ML INJECTABLE / INJECTION AO 2019-10-22 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A211180-001 HALOPERIDOL DECANOATE EQ 50MG BASE/ML INJECTABLE / INJECTION AO 2019-10-22 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A211180-002 HALOPERIDOL DECANOATE EQ 100MG BASE/ML INJECTABLE / INJECTION AO 2019-10-22 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A211180-001 HALOPERIDOL DECANOATE EQ 50MG BASE/ML INJECTABLE / INJECTION AO 2019-10-22 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A211180-002 HALOPERIDOL DECANOATE EQ 100MG BASE/ML INJECTABLE / INJECTION AO 2019-10-22 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A211180-001 HALOPERIDOL DECANOATE EQ 50MG BASE/ML INJECTABLE / INJECTION AO 2019-10-22 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A211180-002 HALOPERIDOL DECANOATE EQ 100MG BASE/ML INJECTABLE / INJECTION AO 2019-10-22 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A211180-001 HALOPERIDOL DECANOATE EQ 50MG BASE/ML INJECTABLE / INJECTION AO 2019-10-22 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A211180-002 HALOPERIDOL DECANOATE EQ 100MG BASE/ML INJECTABLE / INJECTION AO 2019-10-22 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A211180-001 HALOPERIDOL DECANOATE EQ 50MG BASE/ML INJECTABLE / INJECTION AO 2019-10-22 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A211180-002 HALOPERIDOL DECANOATE EQ 100MG BASE/ML INJECTABLE / INJECTION AO 2019-10-22 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A211180-001 HALOPERIDOL DECANOATE EQ 50MG BASE/ML INJECTABLE / INJECTION AO 2019-10-22 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A211180-002 HALOPERIDOL DECANOATE EQ 100MG BASE/ML INJECTABLE / INJECTION AO 2019-10-22 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A211180-001 HALOPERIDOL DECANOATE EQ 50MG BASE/ML INJECTABLE / INJECTION AO 2019-10-22 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A211180-002 HALOPERIDOL DECANOATE EQ 100MG BASE/ML INJECTABLE / INJECTION AO 2019-10-22 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A211180-001 HALOPERIDOL DECANOATE EQ 50MG BASE/ML INJECTABLE / INJECTION AO 2019-10-22 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A211180-002 HALOPERIDOL DECANOATE EQ 100MG BASE/ML INJECTABLE / INJECTION AO 2019-10-22 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A211180-001 HALOPERIDOL DECANOATE EQ 50MG BASE/ML INJECTABLE / INJECTION AO 2019-10-22 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A211180-002 HALOPERIDOL DECANOATE EQ 100MG BASE/ML INJECTABLE / INJECTION AO 2019-10-22 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A211180-001 HALOPERIDOL DECANOATE EQ 50MG BASE/ML INJECTABLE / INJECTION AO 2019-10-22 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A211180-002 HALOPERIDOL DECANOATE EQ 100MG BASE/ML INJECTABLE / INJECTION AO 2019-10-22 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A211180-001 HALOPERIDOL DECANOATE EQ 50MG BASE/ML INJECTABLE / INJECTION AO 2019-10-22 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A211180-002 HALOPERIDOL DECANOATE EQ 100MG BASE/ML INJECTABLE / INJECTION AO 2019-10-22 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A211180-001 HALOPERIDOL DECANOATE EQ 50MG BASE/ML INJECTABLE / INJECTION AO 2019-10-22 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A211180-002 HALOPERIDOL DECANOATE EQ 100MG BASE/ML INJECTABLE / INJECTION AO 2019-10-22 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A211180-001 HALOPERIDOL DECANOATE EQ 50MG BASE/ML INJECTABLE / INJECTION AO 2019-10-22 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A211180-002 HALOPERIDOL DECANOATE EQ 100MG BASE/ML INJECTABLE / INJECTION AO 2019-10-22 4b0b4de00fa7…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 84 observed states.
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