Home NDC 55154-5059 Haloperidol
Product NDC 55154-5059
11-digit product format 551545059
Labeler code 55154
Product ID 55154-5059_5565499e-48d0-4218-a6db-09663499f541
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name haloperidol
Dosage form TABLET
Route ORAL
Labeler Cardinal Health 107, LLC
Application ANDA070278
Marketing category ANDA
Marketing start 2004-02-15
Substance HALOPERIDOL
Active strength 5 mg/1
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 1 .
Orange Book products# Current product rows page 1 of 1 · 6 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A070278-001 HALOPERIDOL HALOPERIDOL 2MG TABLET / ORAL AB RS 1986-06-10 A070278-002 HALOPERIDOL HALOPERIDOL 10MG TABLET / ORAL AB 2009-07-16 A070278-003 HALOPERIDOL HALOPERIDOL 20MG TABLET / ORAL 2009-07-16 A070278-004 HALOPERIDOL HALOPERIDOL 1MG TABLET / ORAL AB 1986-06-10 A070278-005 HALOPERIDOL HALOPERIDOL 5MG TABLET / ORAL AB 1986-06-10 A070278-006 HALOPERIDOL HALOPERIDOL 0.5MG TABLET / ORAL AB 1986-06-10
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 5 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 7 · 246 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 2026-02-19 14:30 UTC 2026-02 A070278-001 HALOPERIDOL 2MG TABLET / ORAL AB RS 1986-06-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A070278-002 HALOPERIDOL 10MG TABLET / ORAL AB 2009-07-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A070278-003 HALOPERIDOL 20MG TABLET / ORAL AB 2009-07-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A070278-004 HALOPERIDOL 1MG TABLET / ORAL AB 1986-06-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A070278-005 HALOPERIDOL 5MG TABLET / ORAL AB 1986-06-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A070278-006 HALOPERIDOL 0.5MG TABLET / ORAL AB 1986-06-10 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A070278-001 HALOPERIDOL 2MG TABLET / ORAL AB RS 1986-06-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A070278-002 HALOPERIDOL 10MG TABLET / ORAL AB 2009-07-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A070278-003 HALOPERIDOL 20MG TABLET / ORAL AB 2009-07-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A070278-004 HALOPERIDOL 1MG TABLET / ORAL AB 1986-06-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A070278-005 HALOPERIDOL 5MG TABLET / ORAL AB 1986-06-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A070278-006 HALOPERIDOL 0.5MG TABLET / ORAL AB 1986-06-10 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A070278-001 HALOPERIDOL 2MG TABLET / ORAL AB RS 1986-06-10 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A070278-002 HALOPERIDOL 10MG TABLET / ORAL AB 2009-07-16 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A070278-003 HALOPERIDOL 20MG TABLET / ORAL AB 2009-07-16 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A070278-004 HALOPERIDOL 1MG TABLET / ORAL AB 1986-06-10 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A070278-005 HALOPERIDOL 5MG TABLET / ORAL AB 1986-06-10 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A070278-006 HALOPERIDOL 0.5MG TABLET / ORAL AB 1986-06-10 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A070278-001 HALOPERIDOL 2MG TABLET / ORAL AB RS 1986-06-10 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A070278-002 HALOPERIDOL 10MG TABLET / ORAL AB 2009-07-16 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A070278-003 HALOPERIDOL 20MG TABLET / ORAL AB 2009-07-16 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A070278-004 HALOPERIDOL 1MG TABLET / ORAL AB 1986-06-10 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A070278-005 HALOPERIDOL 5MG TABLET / ORAL AB 1986-06-10 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A070278-006 HALOPERIDOL 0.5MG TABLET / ORAL AB 1986-06-10 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A070278-001 HALOPERIDOL 2MG TABLET / ORAL AB RS 1986-06-10 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A070278-002 HALOPERIDOL 10MG TABLET / ORAL AB 2009-07-16 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A070278-003 HALOPERIDOL 20MG TABLET / ORAL AB 2009-07-16 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A070278-004 HALOPERIDOL 1MG TABLET / ORAL AB 1986-06-10 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A070278-005 HALOPERIDOL 5MG TABLET / ORAL AB 1986-06-10 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A070278-006 HALOPERIDOL 0.5MG TABLET / ORAL AB 1986-06-10 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A070278-001 HALOPERIDOL 2MG TABLET / ORAL AB RS 1986-06-10 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A070278-002 HALOPERIDOL 10MG TABLET / ORAL AB 2009-07-16 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A070278-003 HALOPERIDOL 20MG TABLET / ORAL AB 2009-07-16 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A070278-004 HALOPERIDOL 1MG TABLET / ORAL AB 1986-06-10 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A070278-005 HALOPERIDOL 5MG TABLET / ORAL AB 1986-06-10 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A070278-006 HALOPERIDOL 0.5MG TABLET / ORAL AB 1986-06-10 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A070278-001 HALOPERIDOL 2MG TABLET / ORAL AB RS 1986-06-10 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A070278-002 HALOPERIDOL 10MG TABLET / ORAL AB 2009-07-16 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A070278-003 HALOPERIDOL 20MG TABLET / ORAL AB 2009-07-16 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A070278-004 HALOPERIDOL 1MG TABLET / ORAL AB 1986-06-10 2680178bc6a6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 7 · 241 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 5 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination J6292F8L3D Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 310672 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 55154-5059-0 Haloperidol 1 in 1 BLISTER PACK TABLET 1 8 55154-5059-0 Haloperidol 10 in 1 BAG TABLET 10 8
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 55154-5059 HALOPERIDOL TABLET [CARDINAL HEALTH 107, LLC] 7 Current NDC, Legacy NDC, 2 package rows 20240313_8ca14b79-6671-4e44-aa34-6564a92aa197.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 Cardinal Health 107, LLC 8ca14b79-6671-4e44-aa34-6564a92aa197 2025-10-14 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 070278 application number: ANDA070278 ndc (product): 55154-5059 Haloperidol HALOPERIDOL Mylan Institutional Inc. ad7d2f17-a4e8-4ebc-9baf-5983ac626782 2025-09-02 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 070278 application number: ANDA070278 Haloperidol HALOPERIDOL Coupler LLC 2ccc2e26-de98-af81-e063-6394a90a040b 2025-01-28 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 070278 application number: ANDA070278 Haloperidol HALOPERIDOL Mylan Pharmaceuticals Inc. c559b0b0-4087-d12a-e718-c18ccb6811e6 2025-01-15 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 070278 application number: ANDA070278
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 55154-5059-0 55154505900 10 BLISTER PACK in 1 BAG (55154-5059-0) / 1 TABLET in 1 BLISTER PACK 10 blister pack 2004-02-15 0000-00-00 No No Current