Home NDC 50458-253 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 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 date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N018701-001 HALDOL HALOPERIDOL DECANOATE EQ 50MG BASE/ML INJECTABLE / INJECTION RLD 1986-01-14 N018701-002 HALDOL HALOPERIDOL DECANOATE EQ 100MG BASE/ML INJECTABLE / INJECTION RLD 1997-01-31
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-18 06:07:40 2026-07 N018701-001 HALDOL EQ 50MG BASE/ML INJECTABLE / INJECTION RLD 1986-01-14 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N018701-002 HALDOL EQ 100MG BASE/ML INJECTABLE / INJECTION RLD 1997-01-31 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N018701-001 HALDOL EQ 50MG BASE/ML INJECTABLE / INJECTION RLD 1986-01-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N018701-002 HALDOL EQ 100MG BASE/ML INJECTABLE / INJECTION RLD 1997-01-31 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N018701-001 HALDOL EQ 50MG BASE/ML INJECTABLE / INJECTION RLD 1986-01-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N018701-002 HALDOL EQ 100MG BASE/ML INJECTABLE / INJECTION RLD 1997-01-31 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N018701-001 HALDOL EQ 50MG BASE/ML INJECTABLE / INJECTION AO RLD, RS 1986-01-14 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N018701-002 HALDOL EQ 100MG BASE/ML INJECTABLE / INJECTION AO RLD, RS 1997-01-31 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N018701-001 HALDOL EQ 50MG BASE/ML INJECTABLE / INJECTION AO RLD, RS 1986-01-14 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N018701-002 HALDOL EQ 100MG BASE/ML INJECTABLE / INJECTION AO RLD, RS 1997-01-31 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N018701-001 HALDOL EQ 50MG BASE/ML INJECTABLE / INJECTION AO RLD, RS 1986-01-14 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N018701-002 HALDOL EQ 100MG BASE/ML INJECTABLE / INJECTION AO RLD, RS 1997-01-31 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N018701-001 HALDOL EQ 50MG BASE/ML INJECTABLE / INJECTION AO RLD, RS 1986-01-14 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N018701-002 HALDOL EQ 100MG BASE/ML INJECTABLE / INJECTION AO RLD, RS 1997-01-31 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N018701-001 HALDOL EQ 50MG BASE/ML INJECTABLE / INJECTION AO RLD, RS 1986-01-14 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N018701-002 HALDOL EQ 100MG BASE/ML INJECTABLE / INJECTION AO RLD, RS 1997-01-31 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N018701-001 HALDOL EQ 50MG BASE/ML INJECTABLE / INJECTION AO RLD, RS 1986-01-14 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N018701-002 HALDOL EQ 100MG BASE/ML INJECTABLE / INJECTION AO RLD, RS 1997-01-31 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N018701-001 HALDOL EQ 50MG BASE/ML INJECTABLE / INJECTION AO RLD, RS 1986-01-14 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N018701-002 HALDOL EQ 100MG BASE/ML INJECTABLE / INJECTION AO RLD, RS 1997-01-31 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N018701-001 HALDOL EQ 50MG BASE/ML INJECTABLE / INJECTION AO RLD, RS 1986-01-14 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N018701-002 HALDOL EQ 100MG BASE/ML INJECTABLE / INJECTION AO RLD, RS 1997-01-31 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N018701-001 HALDOL EQ 50MG BASE/ML INJECTABLE / INJECTION AO RLD, RS 1986-01-14 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N018701-002 HALDOL EQ 100MG BASE/ML INJECTABLE / INJECTION AO RLD, RS 1997-01-31 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N018701-001 HALDOL EQ 50MG BASE/ML INJECTABLE / INJECTION AO RLD, RS 1986-01-14 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N018701-002 HALDOL EQ 100MG BASE/ML INJECTABLE / INJECTION AO RLD, RS 1997-01-31 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N018701-001 HALDOL EQ 50MG BASE/ML INJECTABLE / INJECTION AO RLD, RS 1986-01-14 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N018701-002 HALDOL EQ 100MG BASE/ML INJECTABLE / INJECTION AO RLD, RS 1997-01-31 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N018701-001 HALDOL EQ 50MG BASE/ML INJECTABLE / INJECTION AO RLD, RS 1986-01-14 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N018701-002 HALDOL EQ 100MG BASE/ML INJECTABLE / INJECTION AO RLD, RS 1997-01-31 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N018701-001 HALDOL EQ 50MG BASE/ML INJECTABLE / INJECTION AO RLD, RS 1986-01-14 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N018701-002 HALDOL EQ 100MG BASE/ML INJECTABLE / INJECTION AO RLD, RS 1997-01-31 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N018701-001 HALDOL EQ 50MG BASE/ML INJECTABLE / INJECTION AO RLD, RS 1986-01-14 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N018701-002 HALDOL EQ 100MG BASE/ML INJECTABLE / INJECTION AO RLD, RS 1997-01-31 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N018701-001 HALDOL EQ 50MG BASE/ML INJECTABLE / INJECTION AO RLD, RS 1986-01-14 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N018701-002 HALDOL EQ 100MG BASE/ML INJECTABLE / INJECTION AO RLD, RS 1997-01-31 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N018701-001 HALDOL EQ 50MG BASE/ML INJECTABLE / INJECTION AO RLD, RS 1986-01-14 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N018701-002 HALDOL EQ 100MG BASE/ML INJECTABLE / INJECTION AO RLD, RS 1997-01-31 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N018701-001 HALDOL EQ 50MG BASE/ML INJECTABLE / INJECTION AO RLD, RS 1986-01-14 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N018701-002 HALDOL EQ 100MG BASE/ML INJECTABLE / INJECTION AO RLD, RS 1997-01-31 bb7c543d1eb4…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 76 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Haldol Decanoate Active Ingredients# Ingredient, Strength table Ingredient Strength HALOPERIDOL DECANOATE 50 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination AC20PJ4101 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1719803 Internal RxNorm lookup 1719847 Internal RxNorm lookup 1719862 Internal RxNorm lookup 1720026 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 50458-253-01 Haldol Decanoate 1 mL in 1 AMPULE INJECTION 1 25 50458-253-01 Haldol Decanoate 10 in 1 BOX INJECTION 10 25 50458-253-03 Haldol Decanoate 3 in 1 BOX INJECTION 3 25 50458-253-03 Haldol Decanoate 1 mL in 1 AMPULE INJECTION 1 25
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50458-253 HALDOL DECANOATE (HALOPERIDOL DECANOATE) INJECTION [JANSSEN PHARMACEUTICALS, INC.] 24 Current NDC, Legacy NDC, 4 package rows 20250131_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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 50458-253-01 50458025301 1 mL in 1 AMPULE 1 ml Historical 50458-253-03 50458025303 3 AMPULE in 1 BOX (50458-253-03) / 1 mL in 1 AMPULE 3 ampule 1986-01-14 2027-05-31 No No Current