Home NDC 0378-0257 Haloperidol
Product NDC 0378-0257
11-digit product format 003780257
Labeler code 0378
Product ID 0378-0257_1b33ae94-4fa5-4298-a713-3e049c47588c
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name haloperidol
Dosage form TABLET
Route ORAL
Labeler Mylan Pharmaceuticals Inc.
Application ANDA070278
Marketing category ANDA
Marketing start 1986-06-10
Marketing end 2027-05-31
Substance HALOPERIDOL
Active strength 1 mg/1
Pharmacologic classes Typical Antipsychotic [EPC]
NDC exclude flag No
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 Active Ingredients# Ingredient, Strength table Ingredient Strength HALOPERIDOL 1 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 · 6 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 197754 Internal RxNorm lookup 310670 Internal RxNorm lookup 310671 Internal RxNorm lookup 310672 Internal RxNorm lookup 314034 Internal RxNorm lookup 314035 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 0378-0257-01 Haloperidol 100 in 1 BOTTLE, PLASTIC TABLET 100 22 0378-0257-10 Haloperidol 1000 in 1 BOTTLE, PLASTIC TABLET 1000 22
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded HALOPERIDOL ACTIVE INGREDIENT J6292F8L3D HALOPERIDOL TABLET [MYLAN PHARMACEUTICALS INC.] 11 HALOPERIDOL ACTIVE MOIETY J6292F8L3D HALOPERIDOL TABLET [MYLAN PHARMACEUTICALS INC.] 11 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U HALOPERIDOL TABLET [MYLAN PHARMACEUTICALS INC.] 11 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD HALOPERIDOL TABLET [MYLAN PHARMACEUTICALS INC.] 11 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 HALOPERIDOL TABLET [MYLAN PHARMACEUTICALS INC.] 11 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 HALOPERIDOL TABLET [MYLAN PHARMACEUTICALS INC.] 11 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 HALOPERIDOL TABLET [MYLAN PHARMACEUTICALS INC.] 11 SODIUM LAURYL SULFATE INACTIVE INGREDIENT 368GB5141J HALOPERIDOL TABLET [MYLAN PHARMACEUTICALS INC.] 11 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ HALOPERIDOL TABLET [MYLAN PHARMACEUTICALS INC.] 11 HALOPERIDOL ACTIVE INGREDIENT J6292F8L3D HALOPERIDOL TABLET [MYLAN INSTITUTIONAL INC.] 9 HALOPERIDOL ACTIVE MOIETY J6292F8L3D HALOPERIDOL TABLET [MYLAN INSTITUTIONAL INC.] 9 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U HALOPERIDOL TABLET [MYLAN INSTITUTIONAL INC.] 9 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD HALOPERIDOL TABLET [MYLAN INSTITUTIONAL INC.] 9 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 HALOPERIDOL TABLET [MYLAN INSTITUTIONAL INC.] 9 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 HALOPERIDOL TABLET [MYLAN INSTITUTIONAL INC.] 9 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 HALOPERIDOL TABLET [MYLAN INSTITUTIONAL INC.] 9 SODIUM LAURYL SULFATE INACTIVE INGREDIENT 368GB5141J HALOPERIDOL TABLET [MYLAN INSTITUTIONAL INC.] 9 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ HALOPERIDOL TABLET [MYLAN INSTITUTIONAL INC.] 9 HALOPERIDOL ACTIVE INGREDIENT J6292F8L3D HALOPERIDOL TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 5 HALOPERIDOL ACTIVE MOIETY J6292F8L3D HALOPERIDOL TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 5 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U HALOPERIDOL TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 5 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 HALOPERIDOL TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 5 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 HALOPERIDOL TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 5 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 HALOPERIDOL TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 5 SODIUM LAURYL SULFATE INACTIVE INGREDIENT 368GB5141J HALOPERIDOL TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 5 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ HALOPERIDOL TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 5 HALOPERIDOL ACTIVE INGREDIENT J6292F8L3D HALOPERIDOL TABLET [PHYSICIANS TOTAL CARE, INC.] 4 HALOPERIDOL ACTIVE MOIETY J6292F8L3D HALOPERIDOL TABLET [PHYSICIANS TOTAL CARE, INC.] 4 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U HALOPERIDOL TABLET [PHYSICIANS TOTAL CARE, INC.] 4 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD HALOPERIDOL TABLET [PHYSICIANS TOTAL CARE, INC.] 4 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 HALOPERIDOL TABLET [PHYSICIANS TOTAL CARE, INC.] 4 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 HALOPERIDOL TABLET [PHYSICIANS TOTAL CARE, INC.] 4 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 HALOPERIDOL TABLET [PHYSICIANS TOTAL CARE, INC.] 4 SODIUM LAURYL SULFATE INACTIVE INGREDIENT 368GB5141J HALOPERIDOL TABLET [PHYSICIANS TOTAL CARE, INC.] 4 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ HALOPERIDOL TABLET [PHYSICIANS TOTAL CARE, INC.] 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0378-0257 HALOPERIDOL TABLET [MYLAN PHARMACEUTICALS INC.] 21 Current NDC, Legacy NDC, 2 package rows 20250326_c559b0b0-4087-d12a-e718-c18ccb6811e6.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 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 ndc (product): 0378-0257
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 0378-0257-01 00378025701 100 TABLET in 1 BOTTLE, PLASTIC (0378-0257-01) 100 tablet 1986-06-10 0000-00-00 No No Current 0378-0257-10 00378025710 1000 TABLET in 1 BOTTLE, PLASTIC (0378-0257-10) 1000 tablet 1986-06-10 2027-05-31 No No Current