Home NDC 0904-7504 Haloperidol
Product NDC 0904-7504
11-digit product format 009047504
Labeler code 0904
Product ID 0904-7504_8a1014d0-d917-40b7-bddd-9ac97df91ef4
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name haloperidol
Dosage form TABLET
Route ORAL
Labeler Major Pharmaceuticals
Application ANDA216918
Marketing category ANDA
Marketing start 2025-01-28
Substance HALOPERIDOL
Active strength 2 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 42 .
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 A216918-001 HALOPERIDOL HALOPERIDOL 0.5MG TABLET / ORAL AB 2024-04-11 A216918-002 HALOPERIDOL HALOPERIDOL 1MG TABLET / ORAL AB 2024-04-11 A216918-003 HALOPERIDOL HALOPERIDOL 2MG TABLET / ORAL AB 2024-04-11 A216918-004 HALOPERIDOL HALOPERIDOL 5MG TABLET / ORAL AB 2024-04-11 A216918-005 HALOPERIDOL HALOPERIDOL 10MG TABLET / ORAL AB 2024-04-11 A216918-006 HALOPERIDOL HALOPERIDOL 20MG TABLET / ORAL AB 2024-04-11
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 6 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 3 · 96 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 A216918-001 HALOPERIDOL 0.5MG TABLET / ORAL AB 2024-04-11 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A216918-002 HALOPERIDOL 1MG TABLET / ORAL AB 2024-04-11 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A216918-003 HALOPERIDOL 2MG TABLET / ORAL AB 2024-04-11 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A216918-004 HALOPERIDOL 5MG TABLET / ORAL AB 2024-04-11 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A216918-005 HALOPERIDOL 10MG TABLET / ORAL AB 2024-04-11 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A216918-006 HALOPERIDOL 20MG TABLET / ORAL AB 2024-04-11 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A216918-001 HALOPERIDOL 0.5MG TABLET / ORAL AB 2024-04-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A216918-002 HALOPERIDOL 1MG TABLET / ORAL AB 2024-04-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A216918-003 HALOPERIDOL 2MG TABLET / ORAL AB 2024-04-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A216918-004 HALOPERIDOL 5MG TABLET / ORAL AB 2024-04-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A216918-005 HALOPERIDOL 10MG TABLET / ORAL AB 2024-04-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A216918-006 HALOPERIDOL 20MG TABLET / ORAL AB 2024-04-11 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216918-001 HALOPERIDOL 0.5MG TABLET / ORAL AB 2024-04-11 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216918-002 HALOPERIDOL 1MG TABLET / ORAL AB 2024-04-11 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216918-003 HALOPERIDOL 2MG TABLET / ORAL AB 2024-04-11 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216918-004 HALOPERIDOL 5MG TABLET / ORAL AB 2024-04-11 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216918-005 HALOPERIDOL 10MG TABLET / ORAL AB 2024-04-11 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216918-006 HALOPERIDOL 20MG TABLET / ORAL AB 2024-04-11 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A216918-001 HALOPERIDOL 0.5MG TABLET / ORAL AB 2024-04-11 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A216918-002 HALOPERIDOL 1MG TABLET / ORAL AB 2024-04-11 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A216918-003 HALOPERIDOL 2MG TABLET / ORAL AB 2024-04-11 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A216918-004 HALOPERIDOL 5MG TABLET / ORAL AB 2024-04-11 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A216918-005 HALOPERIDOL 10MG TABLET / ORAL AB 2024-04-11 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A216918-006 HALOPERIDOL 20MG TABLET / ORAL AB 2024-04-11 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A216918-001 HALOPERIDOL 0.5MG TABLET / ORAL AB 2024-04-11 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A216918-002 HALOPERIDOL 1MG TABLET / ORAL AB 2024-04-11 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A216918-003 HALOPERIDOL 2MG TABLET / ORAL AB 2024-04-11 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A216918-004 HALOPERIDOL 5MG TABLET / ORAL AB 2024-04-11 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A216918-005 HALOPERIDOL 10MG TABLET / ORAL AB 2024-04-11 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A216918-006 HALOPERIDOL 20MG TABLET / ORAL AB 2024-04-11 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A216918-001 HALOPERIDOL 0.5MG TABLET / ORAL AB 2024-04-11 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A216918-002 HALOPERIDOL 1MG TABLET / ORAL AB 2024-04-11 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A216918-003 HALOPERIDOL 2MG TABLET / ORAL AB 2024-04-11 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A216918-004 HALOPERIDOL 5MG TABLET / ORAL AB 2024-04-11 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A216918-005 HALOPERIDOL 10MG TABLET / ORAL AB 2024-04-11 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A216918-006 HALOPERIDOL 20MG TABLET / ORAL AB 2024-04-11 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A216918-001 HALOPERIDOL 0.5MG TABLET / ORAL AB 2024-04-11 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A216918-002 HALOPERIDOL 1MG TABLET / ORAL AB 2024-04-11 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A216918-003 HALOPERIDOL 2MG TABLET / ORAL AB 2024-04-11 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A216918-004 HALOPERIDOL 5MG TABLET / ORAL AB 2024-04-11 03ed91905a0d…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 96 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 2 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 314034 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 0904-7504-61 Haloperidol 100 in 1 CARTON TABLET 100 1 0904-7504-61 Haloperidol 1 in 1 BLISTER PACK TABLET 1 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0904-7504 HALOPERIDOL TABLET [MAJOR PHARMACEUTICALS] 1 Current NDC, 2 package rows 20250130_8a1014d0-d917-40b7-bddd-9ac97df91ef4.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 · 5 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Haloperidol HALOPERIDOL REMEDYREPACK INC. addb5b30-d1f8-47dd-ba4c-94d0b01ae17c 2026-08-14 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 216918 application number: ANDA216918 Haloperidol HALOPERIDOL NCS HealthCare of KY, LLC dba Vangard Labs 8743da03-67f1-4cb0-8159-45141cb5466e 2026-04-14 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 216918 application number: ANDA216918 Haloperidol HALOPERIDOL REMEDYREPACK INC. a0751f2e-05ab-4ba9-9bae-7b791bf1a621 2025-10-01 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 216918 application number: ANDA216918 Haloperidol HALOPERIDOL Major Pharmaceuticals 8a1014d0-d917-40b7-bddd-9ac97df91ef4 2025-01-28 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 216918 application number: ANDA216918 ndc (product): 0904-7504 Haloperidol HALOPERIDOL Lifestar Pharma LLC 00bb61c8-db35-4c04-9ef7-47d447d2496b 2024-11-15 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 216918 application number: ANDA216918
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 0904-7504-61 00904750461 100 BLISTER PACK in 1 CARTON (0904-7504-61) / 1 TABLET in 1 BLISTER PACK 100 blister pack 2025-01-28 No No Current