Home NDC 10147-0922-5 Haloperidol Decanoate
Product NDC 10147-0922
Requested package NDC 10147-0922-5
11-digit product format 101470922
Labeler code 10147
Product ID 10147-0922_2e815b50-b5db-72e4-e063-6294a90afd55
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Haloperidol Decanoate
Dosage form INJECTION
Route INTRAMUSCULAR
Labeler Patriot Pharmaceuticals LLC
Application NDA018701
Marketing category NDA AUTHORIZED GENERIC
Marketing start 2011-06-17
Substance HALOPERIDOL DECANOATE
Active strength 100 mg/mL
Pharmacologic classes Typical Antipsychotic [EPC]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
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 · 82 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 2026-02-19 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…2021-12-28 21:50 UTC 2021-12 N018701-001 HALDOL EQ 50MG BASE/ML INJECTABLE / INJECTION AO RLD, RS 1986-01-14 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N018701-002 HALDOL EQ 100MG BASE/ML INJECTABLE / INJECTION AO RLD, RS 1997-01-31 782e0a99824c…
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 Haloperidol Decanoate
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength HALOPERIDOL DECANOATE 100 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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1719803 Internal RxNorm lookup 1719862 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 10147-0922-5 Haloperidol Decanoate 1 mL in 1 AMPULE INJECTION 1 13 10147-0922-5 Haloperidol Decanoate 5 in 1 BOX INJECTION 5 13
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 10147-0922 HALOPERIDOL DECANOATE INJECTION [PATRIOT PHARMACEUTICALS LLC] 13 Current NDC, Legacy NDC, 2 package rows 20250221_9f0f42a8-5f7c-4be7-93ef-3ec225502cc6.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 10147-0922-5 10147092205 5 AMPULE in 1 BOX (10147-0922-5) / 1 mL in 1 AMPULE 5 ampule 2011-06-17 0000-00-00 No No Current