Home NDC 0615-8355 Haloperidol
Product NDC 0615-8355
11-digit product format 006158355
Labeler code 0615
Product ID 0615-8355_b2861983-5663-4c40-b300-4a5248c6c892
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Haloperidol
Dosage form TABLET
Route ORAL
Labeler NCS HealthCare of KY, LLC dba Vangard Labs
Application ANDA211061
Marketing category ANDA
Marketing start 2020-01-09
Marketing end 2026-05-31
Substance HALOPERIDOL
Active strength 5 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 A211061-001 HALOPERIDOL HALOPERIDOL 0.5MG TABLET / ORAL AB 2020-01-08 A211061-002 HALOPERIDOL HALOPERIDOL 1MG TABLET / ORAL AB 2020-01-08 A211061-003 HALOPERIDOL HALOPERIDOL 2MG TABLET / ORAL AB 2020-01-08 A211061-004 HALOPERIDOL HALOPERIDOL 5MG TABLET / ORAL AB 2020-01-08 A211061-005 HALOPERIDOL HALOPERIDOL 10MG TABLET / ORAL AB 2020-01-08 A211061-006 HALOPERIDOL HALOPERIDOL 20MG TABLET / ORAL AB 2020-01-08
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 6 · 222 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 A211061-001 HALOPERIDOL 0.5MG TABLET / ORAL AB 2020-01-08 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A211061-002 HALOPERIDOL 1MG TABLET / ORAL AB 2020-01-08 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A211061-003 HALOPERIDOL 2MG TABLET / ORAL AB 2020-01-08 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A211061-004 HALOPERIDOL 5MG TABLET / ORAL AB 2020-01-08 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A211061-005 HALOPERIDOL 10MG TABLET / ORAL AB 2020-01-08 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A211061-006 HALOPERIDOL 20MG TABLET / ORAL AB 2020-01-08 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211061-001 HALOPERIDOL 0.5MG TABLET / ORAL AB 2020-01-08 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211061-002 HALOPERIDOL 1MG TABLET / ORAL AB 2020-01-08 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211061-003 HALOPERIDOL 2MG TABLET / ORAL AB 2020-01-08 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211061-004 HALOPERIDOL 5MG TABLET / ORAL AB 2020-01-08 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211061-005 HALOPERIDOL 10MG TABLET / ORAL AB 2020-01-08 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211061-006 HALOPERIDOL 20MG TABLET / ORAL AB 2020-01-08 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A211061-001 HALOPERIDOL 0.5MG TABLET / ORAL AB 2020-01-08 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A211061-002 HALOPERIDOL 1MG TABLET / ORAL AB 2020-01-08 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A211061-003 HALOPERIDOL 2MG TABLET / ORAL AB 2020-01-08 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A211061-004 HALOPERIDOL 5MG TABLET / ORAL AB 2020-01-08 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A211061-005 HALOPERIDOL 10MG TABLET / ORAL AB 2020-01-08 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A211061-006 HALOPERIDOL 20MG TABLET / ORAL AB 2020-01-08 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211061-001 HALOPERIDOL 0.5MG TABLET / ORAL AB 2020-01-08 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211061-002 HALOPERIDOL 1MG TABLET / ORAL AB 2020-01-08 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211061-003 HALOPERIDOL 2MG TABLET / ORAL AB 2020-01-08 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211061-004 HALOPERIDOL 5MG TABLET / ORAL AB 2020-01-08 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211061-005 HALOPERIDOL 10MG TABLET / ORAL AB 2020-01-08 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211061-006 HALOPERIDOL 20MG TABLET / ORAL AB 2020-01-08 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A211061-001 HALOPERIDOL 0.5MG TABLET / ORAL AB 2020-01-08 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A211061-002 HALOPERIDOL 1MG TABLET / ORAL AB 2020-01-08 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A211061-003 HALOPERIDOL 2MG TABLET / ORAL AB 2020-01-08 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A211061-004 HALOPERIDOL 5MG TABLET / ORAL AB 2020-01-08 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A211061-005 HALOPERIDOL 10MG TABLET / ORAL AB 2020-01-08 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A211061-006 HALOPERIDOL 20MG TABLET / ORAL AB 2020-01-08 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A211061-001 HALOPERIDOL 0.5MG TABLET / ORAL AB 2020-01-08 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A211061-002 HALOPERIDOL 1MG TABLET / ORAL AB 2020-01-08 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A211061-003 HALOPERIDOL 2MG TABLET / ORAL AB 2020-01-08 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A211061-004 HALOPERIDOL 5MG TABLET / ORAL AB 2020-01-08 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A211061-005 HALOPERIDOL 10MG TABLET / ORAL AB 2020-01-08 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A211061-006 HALOPERIDOL 20MG TABLET / ORAL AB 2020-01-08 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A211061-001 HALOPERIDOL 0.5MG TABLET / ORAL AB 2020-01-08 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A211061-002 HALOPERIDOL 1MG TABLET / ORAL AB 2020-01-08 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A211061-003 HALOPERIDOL 2MG TABLET / ORAL AB 2020-01-08 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A211061-004 HALOPERIDOL 5MG TABLET / ORAL AB 2020-01-08 2680178bc6a6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 6 · 222 observed states.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0615-8355-39 Haloperidol 30 in 1 BLISTER PACK TABLET 30 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0615-8355 HALOPERIDOL TABLET [NCS HEALTHCARE OF KY, LLC DBA VANGARD LABS] 2 Current NDC, Legacy NDC, 1 package rows 20241020_e7dcb764-d58d-4476-b981-3bd54f0d896e.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 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Haloperidol HALOPERIDOL Upsher-Smith Laboratories, LLC afb3ac3e-7459-42d3-b5ca-e0d6d27ced73 2026-08-05 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 211061 application number: ANDA211061
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0615-8355-39 00615835539 30 TABLET in 1 BLISTER PACK (0615-8355-39) 30 tablet 2020-10-20 2026-05-31 No No Current