Home NDC 0404-9871 Haloperidol Lactate
Product NDC 0404-9871
11-digit product format 004049871
Labeler code 0404
Product ID 0404-9871_74d33642-a53d-4042-aa8f-87460d97fd9f
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Haloperidol
Dosage form INJECTION, SOLUTION
Route INTRAMUSCULAR
Labeler Henry Schein, Inc.
Application ANDA078347
Marketing category ANDA
Marketing start 2022-01-11
Substance HALOPERIDOL LACTATE
Active strength 5 mg/mL
Pharmacologic classes Typical Antipsychotic [EPC]
NDC exclude flag No
Listing certified through 2027-12-31
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 A078347-001 HALOPERIDOL HALOPERIDOL LACTATE EQ 5MG BASE/ML INJECTABLE / INJECTION AP RS 2009-09-14
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A078347-001 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 A078347-001 HALOPERIDOL EQ 5MG BASE/ML INJECTABLE / INJECTION AP RS 2009-09-14 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A078347-001 HALOPERIDOL EQ 5MG BASE/ML INJECTABLE / INJECTION AP RS 2009-09-14 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078347-001 HALOPERIDOL EQ 5MG BASE/ML INJECTABLE / INJECTION AP RS 2009-09-14 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A078347-001 HALOPERIDOL EQ 5MG BASE/ML INJECTABLE / INJECTION AP RS 2009-09-14 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078347-001 HALOPERIDOL EQ 5MG BASE/ML INJECTABLE / INJECTION AP RS 2009-09-14 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078347-001 HALOPERIDOL EQ 5MG BASE/ML INJECTABLE / INJECTION AP RS 2009-09-14 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078347-001 HALOPERIDOL EQ 5MG BASE/ML INJECTABLE / INJECTION AP RS 2009-09-14 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078347-001 HALOPERIDOL EQ 5MG BASE/ML INJECTABLE / INJECTION AP RS 2009-09-14 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078347-001 HALOPERIDOL EQ 5MG BASE/ML INJECTABLE / INJECTION AP RS 2009-09-14 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078347-001 HALOPERIDOL EQ 5MG BASE/ML INJECTABLE / INJECTION AP RS 2009-09-14 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A078347-001 HALOPERIDOL EQ 5MG BASE/ML INJECTABLE / INJECTION AP RS 2009-09-14 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A078347-001 HALOPERIDOL EQ 5MG BASE/ML INJECTABLE / INJECTION AP RS 2009-09-14 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A078347-001 HALOPERIDOL EQ 5MG BASE/ML INJECTABLE / INJECTION AP RS 2009-09-14 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A078347-001 HALOPERIDOL EQ 5MG BASE/ML INJECTABLE / INJECTION AP RS 2009-09-14 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A078347-001 HALOPERIDOL EQ 5MG BASE/ML INJECTABLE / INJECTION AP RS 2009-09-14 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A078347-001 HALOPERIDOL EQ 5MG BASE/ML INJECTABLE / INJECTION AP RS 2009-09-14 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A078347-001 HALOPERIDOL EQ 5MG BASE/ML INJECTABLE / INJECTION AP RS 2009-09-14 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A078347-001 HALOPERIDOL EQ 5MG BASE/ML INJECTABLE / INJECTION AP RS 2009-09-14 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A078347-001 HALOPERIDOL EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2009-09-14 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A078347-001 HALOPERIDOL EQ 5MG BASE/ML INJECTABLE / INJECTION AP RS 2009-09-14 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A078347-001 HALOPERIDOL EQ 5MG BASE/ML INJECTABLE / INJECTION AP RS 2009-09-14 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A078347-001 HALOPERIDOL EQ 5MG BASE/ML INJECTABLE / INJECTION AP RS 2009-09-14 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A078347-001 HALOPERIDOL EQ 5MG BASE/ML INJECTABLE / INJECTION AP RS 2009-09-14 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A078347-001 HALOPERIDOL EQ 5MG BASE/ML INJECTABLE / INJECTION AP RS 2009-09-14 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A078347-001 HALOPERIDOL EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2009-09-14 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A078347-001 HALOPERIDOL EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2009-09-14 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A078347-001 HALOPERIDOL EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2009-09-14 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A078347-001 HALOPERIDOL EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2009-09-14 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A078347-001 HALOPERIDOL EQ 5MG BASE/ML INJECTABLE / INJECTION AP RS 2009-09-14 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A078347-001 HALOPERIDOL EQ 5MG BASE/ML INJECTABLE / INJECTION AP RS 2009-09-14 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A078347-001 HALOPERIDOL EQ 5MG BASE/ML INJECTABLE / INJECTION AP RS 2009-09-14 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A078347-001 HALOPERIDOL EQ 5MG BASE/ML INJECTABLE / INJECTION AP RS 2009-09-14 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A078347-001 HALOPERIDOL EQ 5MG BASE/ML INJECTABLE / INJECTION AP RS 2009-09-14 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A078347-001 HALOPERIDOL EQ 5MG BASE/ML INJECTABLE / INJECTION AP RS 2009-09-14 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A078347-001 HALOPERIDOL EQ 5MG BASE/ML INJECTABLE / INJECTION AP RS 2009-09-14 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A078347-001 HALOPERIDOL EQ 5MG BASE/ML INJECTABLE / INJECTION AP RS 2009-09-14 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A078347-001 HALOPERIDOL EQ 5MG BASE/ML INJECTABLE / INJECTION AP RS 2009-09-14 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A078347-001 HALOPERIDOL EQ 5MG BASE/ML INJECTABLE / INJECTION AP RS 2009-09-14 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A078347-001 HALOPERIDOL EQ 5MG BASE/ML INJECTABLE / INJECTION AP RS 2009-09-14 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A078347-001 HALOPERIDOL EQ 5MG BASE/ML INJECTABLE / INJECTION AP RS 2009-09-14 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 Lactate
Listing expiration 2027-12-31 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 0404-9871-01 Haloperidol Lactate 1 mL in 1 VIAL INJECTION, SOLUTION 1 7 0404-9871-01 Haloperidol Lactate 1 in 1 BAG INJECTION, SOLUTION 1 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0404-9871 HALOPERIDOL LACTATE (HALOPERIDOL) INJECTION, SOLUTION [HENRY SCHEIN, INC.] 5 Current NDC, Legacy NDC, 2 package rows 20240502_65df5d2d-79aa-41d4-866a-566e520320f7.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 LACTATE HALOPERIDOL LACTATE REMEDYREPACK INC. 4289f7db-e25d-4578-8adf-f0222ae64aa6 2026-07-14 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 078347 application number: ANDA078347 HALOPERIDOL LACTATE HALOPERIDOL LACTATE Cardinal Health 107, LLC 7d1a9689-23c8-44ef-a474-8c607e13d794 2026-06-02 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 078347 application number: ANDA078347 Haloperidol Lactate HALOPERIDOL Henry Schein, Inc. 65df5d2d-79aa-41d4-866a-566e520320f7 2026-03-02 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 078347 application number: ANDA078347 ndc (product): 0404-9871 HALOPERIDOL LACTATE HALOPERIDOL LACTATE Mylan Institutional LLC 909259a3-7627-4d1e-91d3-3363b3493599 2024-11-14 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 078347 application number: ANDA078347
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 0404-9871-01 00404987101 1 VIAL in 1 BAG (0404-9871-01) / 1 mL in 1 VIAL 1 vial 2022-01-11 0000-00-00 No No Current