Home NDC 70518-4240 Haloperidol Decanoate
Product NDC 70518-4240
11-digit product format 705184240
Labeler code 70518
Product ID 70518-4240_4006fb6f-a731-50ea-e063-6394a90a5124
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Haloperidol Decanoate
Dosage form INJECTION
Route INTRAMUSCULAR
Labeler REMEDYREPACK INC.
Application ANDA216730
Marketing category ANDA
Marketing start 2024-12-16
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 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 A216730-001 HALOPERIDOL DECANOATE HALOPERIDOL DECANOATE EQ 50MG BASE/ML INJECTABLE / INJECTION AO RS 2023-05-23 A216730-002 HALOPERIDOL DECANOATE HALOPERIDOL DECANOATE EQ 100MG BASE/ML INJECTABLE / INJECTION AO RS 2023-05-23
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 2 · 46 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 A216730-001 HALOPERIDOL DECANOATE EQ 50MG BASE/ML INJECTABLE / INJECTION AO RS 2023-05-23 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A216730-002 HALOPERIDOL DECANOATE EQ 100MG BASE/ML INJECTABLE / INJECTION AO RS 2023-05-23 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A216730-001 HALOPERIDOL DECANOATE EQ 50MG BASE/ML INJECTABLE / INJECTION AO RS 2023-05-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A216730-002 HALOPERIDOL DECANOATE EQ 100MG BASE/ML INJECTABLE / INJECTION AO RS 2023-05-23 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216730-001 HALOPERIDOL DECANOATE EQ 50MG BASE/ML INJECTABLE / INJECTION AO RS 2023-05-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216730-002 HALOPERIDOL DECANOATE EQ 100MG BASE/ML INJECTABLE / INJECTION AO RS 2023-05-23 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A216730-001 HALOPERIDOL DECANOATE EQ 50MG BASE/ML INJECTABLE / INJECTION AO 2023-05-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A216730-002 HALOPERIDOL DECANOATE EQ 100MG BASE/ML INJECTABLE / INJECTION AO 2023-05-23 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A216730-001 HALOPERIDOL DECANOATE EQ 50MG BASE/ML INJECTABLE / INJECTION AO 2023-05-23 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A216730-002 HALOPERIDOL DECANOATE EQ 100MG BASE/ML INJECTABLE / INJECTION AO 2023-05-23 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A216730-001 HALOPERIDOL DECANOATE EQ 50MG BASE/ML INJECTABLE / INJECTION AO 2023-05-23 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A216730-002 HALOPERIDOL DECANOATE EQ 100MG BASE/ML INJECTABLE / INJECTION AO 2023-05-23 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A216730-001 HALOPERIDOL DECANOATE EQ 50MG BASE/ML INJECTABLE / INJECTION AO 2023-05-23 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A216730-002 HALOPERIDOL DECANOATE EQ 100MG BASE/ML INJECTABLE / INJECTION AO 2023-05-23 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A216730-001 HALOPERIDOL DECANOATE EQ 50MG BASE/ML INJECTABLE / INJECTION AO 2023-05-23 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A216730-002 HALOPERIDOL DECANOATE EQ 100MG BASE/ML INJECTABLE / INJECTION AO 2023-05-23 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A216730-001 HALOPERIDOL DECANOATE EQ 50MG BASE/ML INJECTABLE / INJECTION AO 2023-05-23 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A216730-002 HALOPERIDOL DECANOATE EQ 100MG BASE/ML INJECTABLE / INJECTION AO 2023-05-23 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A216730-001 HALOPERIDOL DECANOATE EQ 50MG BASE/ML INJECTABLE / INJECTION AO 2023-05-23 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A216730-002 HALOPERIDOL DECANOATE EQ 100MG BASE/ML INJECTABLE / INJECTION AO 2023-05-23 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A216730-001 HALOPERIDOL DECANOATE EQ 50MG BASE/ML INJECTABLE / INJECTION AO 2023-05-23 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A216730-002 HALOPERIDOL DECANOATE EQ 100MG BASE/ML INJECTABLE / INJECTION AO 2023-05-23 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A216730-001 HALOPERIDOL DECANOATE EQ 50MG BASE/ML INJECTABLE / INJECTION AO 2023-05-23 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A216730-002 HALOPERIDOL DECANOATE EQ 100MG BASE/ML INJECTABLE / INJECTION AO 2023-05-23 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A216730-001 HALOPERIDOL DECANOATE EQ 50MG BASE/ML INJECTABLE / INJECTION AO 2023-05-23 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A216730-002 HALOPERIDOL DECANOATE EQ 100MG BASE/ML INJECTABLE / INJECTION AO 2023-05-23 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A216730-001 HALOPERIDOL DECANOATE EQ 50MG BASE/ML INJECTABLE / INJECTION AO 2023-05-23 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A216730-002 HALOPERIDOL DECANOATE EQ 100MG BASE/ML INJECTABLE / INJECTION AO 2023-05-23 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A216730-001 HALOPERIDOL DECANOATE EQ 50MG BASE/ML INJECTABLE / INJECTION AO 2023-05-23 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A216730-002 HALOPERIDOL DECANOATE EQ 100MG BASE/ML INJECTABLE / INJECTION AO 2023-05-23 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A216730-001 HALOPERIDOL DECANOATE EQ 50MG BASE/ML INJECTABLE / INJECTION AO 2023-05-23 6a51e52b5d6a…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A216730-002 HALOPERIDOL DECANOATE EQ 100MG BASE/ML INJECTABLE / INJECTION AO 2023-05-23 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A216730-001 HALOPERIDOL DECANOATE EQ 50MG BASE/ML INJECTABLE / INJECTION AO 2023-05-23 1c564ffb4f44…2024-02-18 07:12 UTC 2024-02 A216730-002 HALOPERIDOL DECANOATE EQ 100MG BASE/ML INJECTABLE / INJECTION AO 2023-05-23 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A216730-001 HALOPERIDOL DECANOATE EQ 50MG BASE/ML INJECTABLE / INJECTION AO 2023-05-23 ea1830bbd6c7…2023-12-20 04:57 UTC 2023-12 A216730-002 HALOPERIDOL DECANOATE EQ 100MG BASE/ML INJECTABLE / INJECTION AO 2023-05-23 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A216730-001 HALOPERIDOL DECANOATE EQ 50MG BASE/ML INJECTABLE / INJECTION AO 2023-05-23 a72a2bbeb626…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A216730-002 HALOPERIDOL DECANOATE EQ 100MG BASE/ML INJECTABLE / INJECTION AO 2023-05-23 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A216730-001 HALOPERIDOL DECANOATE EQ 50MG BASE/ML INJECTABLE / INJECTION AO 2023-05-23 9b2671bbb829…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A216730-002 HALOPERIDOL DECANOATE EQ 100MG BASE/ML INJECTABLE / INJECTION AO 2023-05-23 9b2671bbb829…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 46 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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1719803 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 70518-4240-0 Haloperidol Decanoate 10 in 1 CARTON INJECTION 10 3 70518-4240-1 Haloperidol Decanoate 1 mL in 1 VIAL INJECTION 1 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70518-4240 HALOPERIDOL DECANOATE INJECTION [REMEDYREPACK INC.] 1 Current NDC, 2 package rows 20241218_2cdd9fca-afe5-4bfa-8db1-337beec13c6b.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 · 4 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Haloperidol Decanoate HALOPERIDOL DECANOATE NorthStar RxLLC b83cb022-cfeb-4492-927b-0b461f7201d4 2026-06-15 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 216730 application number: ANDA216730 Haloperidol Decanoate HALOPERIDOL DECANOATE Lifestar Pharma LLC 8a96195e-97cd-4161-96e0-494a1636fa9c 2026-06-15 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 216730 application number: ANDA216730 Haloperidol Decanoate HALOPERIDOL DECANOATE REMEDYREPACK INC. 530f440f-d4e8-423a-99a2-02d02e794ccb 2026-06-01 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 216730 application number: ANDA216730 Haloperidol Decanoate HALOPERIDOL DECANOATE REMEDYREPACK INC. 2cdd9fca-afe5-4bfa-8db1-337beec13c6b 2025-09-30 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 216730 application number: ANDA216730 ndc (product): 70518-4240
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 70518-4240-0 70518424000 10 VIAL in 1 CARTON (70518-4240-0) / 1 mL in 1 VIAL (70518-4240-1) 10 vial 2024-12-16 No No Current 70518-4240-1 70518424001 1 mL in 1 VIAL 1 ml Historical