Home NDC 0143-9319 Haloperidol
Product NDC 0143-9319
11-digit product format 001439319
Labeler code 0143
Product ID 0143-9319_b93ee0dc-a484-402b-8345-3d68ba0c689a
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Haloperidol lactate
Dosage form INJECTION
Route INTRAMUSCULAR
Labeler Hikma Pharmaceuticals USA Inc.
Application ANDA075858
Marketing category ANDA
Marketing start 2018-09-14
Substance HALOPERIDOL LACTATE
Active strength 5 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 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A075858-001 HALOPERIDOL HALOPERIDOL LACTATE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2001-06-18
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A075858-001 AP
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 · 42 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 A075858-001 HALOPERIDOL EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2001-06-18 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A075858-001 HALOPERIDOL EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2001-06-18 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075858-001 HALOPERIDOL EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2001-06-18 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A075858-001 HALOPERIDOL EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2001-06-18 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075858-001 HALOPERIDOL EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2001-06-18 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075858-001 HALOPERIDOL EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2001-06-18 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075858-001 HALOPERIDOL EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2001-06-18 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075858-001 HALOPERIDOL EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2001-06-18 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075858-001 HALOPERIDOL EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2001-06-18 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075858-001 HALOPERIDOL EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2001-06-18 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A075858-001 HALOPERIDOL EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2001-06-18 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A075858-001 HALOPERIDOL EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2001-06-18 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A075858-001 HALOPERIDOL EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2001-06-18 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A075858-001 HALOPERIDOL EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2001-06-18 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A075858-001 HALOPERIDOL EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2001-06-18 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A075858-001 HALOPERIDOL EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2001-06-18 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A075858-001 HALOPERIDOL EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2001-06-18 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A075858-001 HALOPERIDOL EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2001-06-18 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A075858-001 HALOPERIDOL EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2001-06-18 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A075858-001 HALOPERIDOL EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2001-06-18 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A075858-001 HALOPERIDOL EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2001-06-18 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A075858-001 HALOPERIDOL EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2001-06-18 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A075858-001 HALOPERIDOL EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2001-06-18 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A075858-001 HALOPERIDOL EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2001-06-18 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A075858-001 HALOPERIDOL EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2001-06-18 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A075858-001 HALOPERIDOL EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2001-06-18 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A075858-001 HALOPERIDOL EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2001-06-18 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A075858-001 HALOPERIDOL EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2001-06-18 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A075858-001 HALOPERIDOL EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2001-06-18 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A075858-001 HALOPERIDOL EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2001-06-18 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A075858-001 HALOPERIDOL EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2001-06-18 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A075858-001 HALOPERIDOL EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2001-06-18 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A075858-001 HALOPERIDOL EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2001-06-18 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A075858-001 HALOPERIDOL EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2001-06-18 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A075858-001 HALOPERIDOL EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2001-06-18 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A075858-001 HALOPERIDOL EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2001-06-18 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A075858-001 HALOPERIDOL EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2001-06-18 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A075858-001 HALOPERIDOL EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2001-06-18 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A075858-001 HALOPERIDOL EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2001-06-18 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A075858-001 HALOPERIDOL EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2001-06-18 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Haloperidol
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength HALOPERIDOL LACTATE 5 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 6387S86PK3 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1719646 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 0143-9319-25 Haloperidol 1 mL in 1 VIAL INJECTION 1 4 0143-9319-25 Haloperidol 25 in 1 BOX INJECTION 25 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0143-9319 HALOPERIDOL (HALOPERIDOL LACTATE) INJECTION [HIKMA PHARMACEUTICALS USA INC.] 4 Current NDC, Legacy NDC, 2 package rows 20220727_ec7a3560-71c3-43f5-bc6c-d51eadfd2aa1.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 0143-9319-25 00143931925 25 VIAL in 1 BOX (0143-9319-25) / 1 mL in 1 VIAL 25 vial 2018-09-14 0000-00-00 No No Current