Home NDC 0832-1550 Haloperidol
Product NDC 0832-1550
11-digit product format 008321550
Labeler code 0832
Product ID 0832-1550_326f5ed0-bc46-a1f5-e063-6394a90af2c1
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Haloperidol
Dosage form TABLET
Route ORAL
Labeler Upsher-Smith Laboratories, LLC
Application ANDA211061
Marketing category ANDA
Marketing start 2020-01-09
Substance HALOPERIDOL
Active strength 10 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 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.
Additional Listing Data#
Finished product Yes
Brand name base Haloperidol
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength HALOPERIDOL 10 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 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 0832-1550-01 Haloperidol 100 in 1 CARTON TABLET 100 6 0832-1550-11 Haloperidol 100 in 1 BOTTLE TABLET 100 6 0832-1550-89 Haloperidol 1 in 1 BLISTER PACK TABLET 1 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0832-1550 HALOPERIDOL TABLET [UPSHER-SMITH LABORATORIES, LLC] 6 Current NDC, Legacy NDC, 3 package rows 20250419_afb3ac3e-7459-42d3-b5ca-e0d6d27ced73.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.
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 0832-1550-01 00832155001 100 BLISTER PACK in 1 CARTON (0832-1550-01) / 1 TABLET in 1 BLISTER PACK (0832-1550-89) 100 blister pack 2022-09-30 0000-00-00 No No Current 0832-1550-11 00832155011 100 TABLET in 1 BOTTLE (0832-1550-11) 100 tablet 2020-01-13 0000-00-00 No No Current 0832-1550-89 00832155089 1 in 1 BLISTER PACK Historical