Home NDC 67046-1496 Haloperidol
Product NDC 67046-1496
11-digit product format 670461496
Labeler code 67046
Product ID 67046-1496_2ccc2445-6ffa-75b8-e063-6294a90a57f5
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name haloperidol
Dosage form TABLET
Route ORAL
Labeler Coupler LLC
Application ANDA070278
Marketing category ANDA
Marketing start 2025-01-28
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 310670 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 67046-1496-3 Haloperidol 30 in 1 BLISTER PACK TABLET 30 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 67046-1496 HALOPERIDOL TABLET [COUPLER LLC] 1 Current NDC, 1 package rows 20250130_2ccc2e26-de98-af81-e063-6394a90a040b.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 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 ndc (product): 67046-1496 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 Sample Exclude flag Status 67046-1496-3 67046149603 30 TABLET in 1 BLISTER PACK (67046-1496-3) 30 tablet 2025-01-28 No No Current