Home NDC 55154-9553 Haloperidol
Product NDC 55154-9553
11-digit product format 551549553
Labeler code 55154
Product ID 55154-9553_84352a05-b400-4c22-98bc-84a07e0d9929
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name HALOPERIDOL LACTATE
Dosage form INJECTION, SOLUTION
Route INTRAMUSCULAR
Labeler Cardinal Health 107, LLC
Application ANDA075689
Marketing category ANDA
Marketing start 2010-12-15
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 A075689-001 HALOPERIDOL HALOPERIDOL LACTATE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2001-03-09
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A075689-001 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 A075689-001 HALOPERIDOL EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2001-03-09 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A075689-001 HALOPERIDOL EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2001-03-09 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075689-001 HALOPERIDOL EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2001-03-09 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A075689-001 HALOPERIDOL EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2001-03-09 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075689-001 HALOPERIDOL EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2001-03-09 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075689-001 HALOPERIDOL EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2001-03-09 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075689-001 HALOPERIDOL EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2001-03-09 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075689-001 HALOPERIDOL EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2001-03-09 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075689-001 HALOPERIDOL EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2001-03-09 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075689-001 HALOPERIDOL EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2001-03-09 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A075689-001 HALOPERIDOL EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2001-03-09 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A075689-001 HALOPERIDOL EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2001-03-09 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A075689-001 HALOPERIDOL EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2001-03-09 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A075689-001 HALOPERIDOL EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2001-03-09 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A075689-001 HALOPERIDOL EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2001-03-09 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A075689-001 HALOPERIDOL EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2001-03-09 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A075689-001 HALOPERIDOL EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2001-03-09 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A075689-001 HALOPERIDOL EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2001-03-09 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A075689-001 HALOPERIDOL EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2001-03-09 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A075689-001 HALOPERIDOL EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2001-03-09 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A075689-001 HALOPERIDOL EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2001-03-09 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A075689-001 HALOPERIDOL EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2001-03-09 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A075689-001 HALOPERIDOL EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2001-03-09 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A075689-001 HALOPERIDOL EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2001-03-09 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A075689-001 HALOPERIDOL EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2001-03-09 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A075689-001 HALOPERIDOL EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2001-03-09 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A075689-001 HALOPERIDOL EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2001-03-09 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A075689-001 HALOPERIDOL EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2001-03-09 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A075689-001 HALOPERIDOL EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2001-03-09 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A075689-001 HALOPERIDOL EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2001-03-09 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A075689-001 HALOPERIDOL EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2001-03-09 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A075689-001 HALOPERIDOL EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2001-03-09 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A075689-001 HALOPERIDOL EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2001-03-09 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A075689-001 HALOPERIDOL EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2001-03-09 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A075689-001 HALOPERIDOL EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2001-03-09 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A075689-001 HALOPERIDOL EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2001-03-09 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A075689-001 HALOPERIDOL EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2001-03-09 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A075689-001 HALOPERIDOL EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2001-03-09 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A075689-001 HALOPERIDOL EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2001-03-09 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A075689-001 HALOPERIDOL EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2001-03-09 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 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 55154-9553-5 Haloperidol 5 in 1 BAG INJECTION, SOLUTION 5 13 55154-9553-5 Haloperidol 1 mL in 1 VIAL INJECTION, SOLUTION 1 13
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 55154-9553 HALOPERIDOL (HALOPERIDOL LACTATE) INJECTION, SOLUTION [CARDINAL HEALTH 107, LLC] 12 Current NDC, Legacy NDC, 2 package rows 20240119_e2eed126-cb82-42b1-9b48-9cbeb6873b50.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 HALOPERIDOL LACTATE Cardinal Health 107, LLC e2eed126-cb82-42b1-9b48-9cbeb6873b50 2026-06-18 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 075689 application number: ANDA075689 ndc (product): 55154-9553 Haloperidol HALOPERIDOL LACTATE REMEDYREPACK INC. e702b2f0-d464-41c3-977a-d37bb22c0ab0 2026-03-12 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 075689 application number: ANDA075689 Haloperidol HALOPERIDOL LACTATE Fresenius Kabi USA, LLC b1ad2abd-a9d6-44e3-957b-36a73260f4f5 2022-01-25 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 075689 application number: ANDA075689 HALOPERIDOL HALOPERIDOL LACTATE HF Acquisition Co LLC, DBA HealthFirst beb6d1cf-98db-d0a5-e053-2995a90ace90 2021-03-29 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 075689 application number: ANDA075689
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 55154-9553-5 55154955305 5 VIAL in 1 BAG (55154-9553-5) / 1 mL in 1 VIAL 5 vial 2010-12-15 0000-00-00 No No Current