Home NDC 63323-469 Haloperidol Decanoate
Product NDC 63323-469
11-digit product format 633230469
Labeler code 63323
Product ID 63323-469_86dff2aa-2ab3-42fc-989e-619b13ace573
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name HALOPERIDOL DECANOATE
Dosage form INJECTION
Route INTRAMUSCULAR
Labeler Fresenius Kabi USA, LLC
Application ANDA074893
Marketing category ANDA
Marketing start 2000-02-16
Substance HALOPERIDOL DECANOATE
Active strength 50 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 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 A074893-001 HALOPERIDOL DECANOATE HALOPERIDOL DECANOATE EQ 50MG BASE/ML INJECTABLE / INJECTION AO 1997-12-19 A074893-002 HALOPERIDOL DECANOATE HALOPERIDOL DECANOATE EQ 100MG BASE/ML INJECTABLE / INJECTION AO 1997-12-19
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 2026-08-18 06:07:40 2026-07 A074893-001 HALOPERIDOL DECANOATE EQ 50MG BASE/ML INJECTABLE / INJECTION AO 1997-12-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A074893-002 HALOPERIDOL DECANOATE EQ 100MG BASE/ML INJECTABLE / INJECTION AO 1997-12-19 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A074893-001 HALOPERIDOL DECANOATE EQ 50MG BASE/ML INJECTABLE / INJECTION AO 1997-12-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A074893-002 HALOPERIDOL DECANOATE EQ 100MG BASE/ML INJECTABLE / INJECTION AO 1997-12-19 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A074893-001 HALOPERIDOL DECANOATE EQ 50MG BASE/ML INJECTABLE / INJECTION AO 1997-12-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A074893-002 HALOPERIDOL DECANOATE EQ 100MG BASE/ML INJECTABLE / INJECTION AO 1997-12-19 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A074893-001 HALOPERIDOL DECANOATE EQ 50MG BASE/ML INJECTABLE / INJECTION AO 1997-12-19 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A074893-002 HALOPERIDOL DECANOATE EQ 100MG BASE/ML INJECTABLE / INJECTION AO 1997-12-19 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A074893-001 HALOPERIDOL DECANOATE EQ 50MG BASE/ML INJECTABLE / INJECTION AO 1997-12-19 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A074893-002 HALOPERIDOL DECANOATE EQ 100MG BASE/ML INJECTABLE / INJECTION AO 1997-12-19 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A074893-001 HALOPERIDOL DECANOATE EQ 50MG BASE/ML INJECTABLE / INJECTION AO 1997-12-19 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A074893-002 HALOPERIDOL DECANOATE EQ 100MG BASE/ML INJECTABLE / INJECTION AO 1997-12-19 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A074893-001 HALOPERIDOL DECANOATE EQ 50MG BASE/ML INJECTABLE / INJECTION AO 1997-12-19 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A074893-002 HALOPERIDOL DECANOATE EQ 100MG BASE/ML INJECTABLE / INJECTION AO 1997-12-19 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A074893-001 HALOPERIDOL DECANOATE EQ 50MG BASE/ML INJECTABLE / INJECTION AO 1997-12-19 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A074893-002 HALOPERIDOL DECANOATE EQ 100MG BASE/ML INJECTABLE / INJECTION AO 1997-12-19 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A074893-001 HALOPERIDOL DECANOATE EQ 50MG BASE/ML INJECTABLE / INJECTION AO 1997-12-19 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A074893-002 HALOPERIDOL DECANOATE EQ 100MG BASE/ML INJECTABLE / INJECTION AO 1997-12-19 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A074893-001 HALOPERIDOL DECANOATE EQ 50MG BASE/ML INJECTABLE / INJECTION AO 1997-12-19 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A074893-002 HALOPERIDOL DECANOATE EQ 100MG BASE/ML INJECTABLE / INJECTION AO 1997-12-19 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A074893-001 HALOPERIDOL DECANOATE EQ 50MG BASE/ML INJECTABLE / INJECTION AO 1997-12-19 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A074893-002 HALOPERIDOL DECANOATE EQ 100MG BASE/ML INJECTABLE / INJECTION AO 1997-12-19 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A074893-001 HALOPERIDOL DECANOATE EQ 50MG BASE/ML INJECTABLE / INJECTION AO 1997-12-19 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A074893-002 HALOPERIDOL DECANOATE EQ 100MG BASE/ML INJECTABLE / INJECTION AO 1997-12-19 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A074893-001 HALOPERIDOL DECANOATE EQ 50MG BASE/ML INJECTABLE / INJECTION AO 1997-12-19 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A074893-002 HALOPERIDOL DECANOATE EQ 100MG BASE/ML INJECTABLE / INJECTION AO 1997-12-19 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A074893-001 HALOPERIDOL DECANOATE EQ 50MG BASE/ML INJECTABLE / INJECTION AO 1997-12-19 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A074893-002 HALOPERIDOL DECANOATE EQ 100MG BASE/ML INJECTABLE / INJECTION AO 1997-12-19 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A074893-001 HALOPERIDOL DECANOATE EQ 50MG BASE/ML INJECTABLE / INJECTION AO 1997-12-19 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A074893-002 HALOPERIDOL DECANOATE EQ 100MG BASE/ML INJECTABLE / INJECTION AO 1997-12-19 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A074893-001 HALOPERIDOL DECANOATE EQ 50MG BASE/ML INJECTABLE / INJECTION AO 1997-12-19 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A074893-002 HALOPERIDOL DECANOATE EQ 100MG BASE/ML INJECTABLE / INJECTION AO 1997-12-19 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A074893-001 HALOPERIDOL DECANOATE EQ 50MG BASE/ML INJECTABLE / INJECTION AO 1997-12-19 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A074893-002 HALOPERIDOL DECANOATE EQ 100MG BASE/ML INJECTABLE / INJECTION AO 1997-12-19 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A074893-001 HALOPERIDOL DECANOATE EQ 50MG BASE/ML INJECTABLE / INJECTION AO 1997-12-19 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A074893-002 HALOPERIDOL DECANOATE EQ 100MG BASE/ML INJECTABLE / INJECTION AO 1997-12-19 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A074893-001 HALOPERIDOL DECANOATE EQ 50MG BASE/ML INJECTABLE / INJECTION AO 1997-12-19 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A074893-002 HALOPERIDOL DECANOATE EQ 100MG BASE/ML INJECTABLE / INJECTION AO 1997-12-19 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A074893-001 HALOPERIDOL DECANOATE EQ 50MG BASE/ML INJECTABLE / INJECTION AO 1997-12-19 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A074893-002 HALOPERIDOL DECANOATE EQ 100MG BASE/ML INJECTABLE / INJECTION AO 1997-12-19 bb7c543d1eb4…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 84 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 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 859867 Internal RxNorm lookup 859871 Internal RxNorm lookup 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 63323-469-01 Haloperidol Decanoate 1 mL in 1 VIAL INJECTION 1 9 63323-469-01 Haloperidol Decanoate 1 in 1 CARTON INJECTION 1 9 63323-469-05 Haloperidol Decanoate 5 mL in 1 VIAL, MULTI-DOSE INJECTION 5 9 63323-469-05 Haloperidol Decanoate 1 in 1 CARTON INJECTION 1 9
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63323-469 HALOPERIDOL DECANOATE INJECTION [FRESENIUS KABI USA, LLC
] 9 Current NDC, Legacy NDC, 4 package rows 20211106_ca9896e0-fb2e-46a4-8700-20d144c14764.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 63323-469-01 63323046901 1 VIAL in 1 CARTON (63323-469-01) / 1 mL in 1 VIAL 1 vial 2000-02-16 0000-00-00 No No Current 63323-469-05 63323046905 1 VIAL, MULTI-DOSE in 1 CARTON (63323-469-05) / 5 mL in 1 VIAL, MULTI-DOSE 2000-02-16 0000-00-00 No No Current