Home NDC 70518-4285 Haloperidol
Product NDC 70518-4285
11-digit product format 705184285
Labeler code 70518
Product ID 70518-4285_401b5d09-1bca-e6e0-e063-6294a90a2a0a
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name haloperidol
Dosage form TABLET
Route ORAL
Labeler REMEDYREPACK INC.
Application ANDA216918
Marketing category ANDA
Marketing start 2025-02-11
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 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 · 90 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 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…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A216918-005 HALOPERIDOL 10MG TABLET / ORAL AB 2024-04-11 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A216918-006 HALOPERIDOL 20MG TABLET / ORAL AB 2024-04-11 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A216918-001 HALOPERIDOL 0.5MG TABLET / ORAL AB 2024-04-11 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A216918-002 HALOPERIDOL 1MG TABLET / ORAL AB 2024-04-11 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A216918-003 HALOPERIDOL 2MG TABLET / ORAL AB 2024-04-11 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A216918-004 HALOPERIDOL 5MG TABLET / ORAL AB 2024-04-11 2680178bc6a6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 90 observed states.
openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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 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 ndc (product): 70518-4285 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 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
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 70518-4285-0 Haloperidol 30 in 1 BLISTER PACK TABLET 30 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70518-4285 HALOPERIDOL TABLET [REMEDYREPACK INC.] 1 Current NDC, 1 package rows 20250214_a0751f2e-05ab-4ba9-9bae-7b791bf1a621.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 70518-4285-0 70518428500 30 TABLET in 1 BLISTER PACK (70518-4285-0) 30 tablet 2025-02-11 No No Current