Home NDC 35573-440-02 HALOPERIDOL
Product NDC 35573-440
Requested package NDC 35573-440-02
11-digit product format 355730440
Labeler code 35573
Product ID 35573-440_553e9517-6ce2-4105-99fc-02de9c95ad6f
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name HALOPERIDOL
Dosage form TABLET
Route ORAL
Labeler Burel Pharmaceuticals, LLC
Application ANDA071130
Marketing category ANDA
Marketing start 2021-05-31
Marketing end 0000-00-00
Substance HALOPERIDOL
Active strength 2 mg/1
Pharmacologic classes Typical Antipsychotic [EPC]
NDC exclude flag No
Listing certified through 2022-12-31
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 10 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…
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 A071130-001 HALOPERIDOL HALOPERIDOL 2MG TABLET / ORAL AB 1987-02-17 A071130-002 HALOPERIDOL HALOPERIDOL 5MG TABLET / ORAL AB 1987-02-17 A071130-003 HALOPERIDOL HALOPERIDOL 10MG TABLET / ORAL AB 1987-05-12 A071130-004 HALOPERIDOL HALOPERIDOL 0.5MG TABLET / ORAL AB 2026-04-08 A071130-005 HALOPERIDOL HALOPERIDOL 1MG TABLET / ORAL AB 2026-04-08 A071130-006 HALOPERIDOL HALOPERIDOL 20MG TABLET / ORAL AB 2026-04-08
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 2 · 72 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 A071130-001 HALOPERIDOL 2MG TABLET / ORAL AB 1987-02-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A071130-002 HALOPERIDOL 5MG TABLET / ORAL AB 1987-02-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A071130-003 HALOPERIDOL 10MG TABLET / ORAL AB 1987-05-12 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A071130-001 HALOPERIDOL 2MG TABLET / ORAL AB 1987-02-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A071130-002 HALOPERIDOL 5MG TABLET / ORAL AB 1987-02-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A071130-003 HALOPERIDOL 10MG TABLET / ORAL AB 1987-05-12 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A071130-001 HALOPERIDOL 2MG TABLET / ORAL AB 1987-02-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A071130-002 HALOPERIDOL 5MG TABLET / ORAL AB 1987-02-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A071130-003 HALOPERIDOL 10MG TABLET / ORAL AB 1987-05-12 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A071130-001 HALOPERIDOL 2MG TABLET / ORAL AB 1987-02-17 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A071130-002 HALOPERIDOL 5MG TABLET / ORAL AB 1987-02-17 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A071130-003 HALOPERIDOL 10MG TABLET / ORAL AB 1987-05-12 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A071130-001 HALOPERIDOL 2MG TABLET / ORAL AB 1987-02-17 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A071130-002 HALOPERIDOL 5MG TABLET / ORAL AB 1987-02-17 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A071130-003 HALOPERIDOL 10MG TABLET / ORAL AB 1987-05-12 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A071130-001 HALOPERIDOL 2MG TABLET / ORAL AB 1987-02-17 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A071130-002 HALOPERIDOL 5MG TABLET / ORAL AB 1987-02-17 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A071130-003 HALOPERIDOL 10MG TABLET / ORAL AB 1987-05-12 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A071130-001 HALOPERIDOL 2MG TABLET / ORAL AB 1987-02-17 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A071130-002 HALOPERIDOL 5MG TABLET / ORAL AB 1987-02-17 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A071130-003 HALOPERIDOL 10MG TABLET / ORAL AB 1987-05-12 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A071130-001 HALOPERIDOL 2MG TABLET / ORAL AB 1987-02-17 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A071130-002 HALOPERIDOL 5MG TABLET / ORAL AB 1987-02-17 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A071130-003 HALOPERIDOL 10MG TABLET / ORAL AB 1987-05-12 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A071130-001 HALOPERIDOL 2MG TABLET / ORAL AB 1987-02-17 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A071130-002 HALOPERIDOL 5MG TABLET / ORAL AB 1987-02-17 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A071130-003 HALOPERIDOL 10MG TABLET / ORAL AB 1987-05-12 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A071130-001 HALOPERIDOL 2MG TABLET / ORAL AB 1987-02-17 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A071130-002 HALOPERIDOL 5MG TABLET / ORAL AB 1987-02-17 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A071130-003 HALOPERIDOL 10MG TABLET / ORAL AB 1987-05-12 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A071130-001 HALOPERIDOL 2MG TABLET / ORAL AB 1987-02-17 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A071130-002 HALOPERIDOL 5MG TABLET / ORAL AB 1987-02-17 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A071130-003 HALOPERIDOL 10MG TABLET / ORAL AB 1987-05-12 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A071130-001 HALOPERIDOL 2MG TABLET / ORAL AB 1987-02-17 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A071130-002 HALOPERIDOL 5MG TABLET / ORAL AB 1987-02-17 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A071130-003 HALOPERIDOL 10MG TABLET / ORAL AB 1987-05-12 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A071130-001 HALOPERIDOL 2MG TABLET / ORAL AB 1987-02-17 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A071130-002 HALOPERIDOL 5MG TABLET / ORAL AB 1987-02-17 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A071130-003 HALOPERIDOL 10MG TABLET / ORAL AB 1987-05-12 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A071130-001 HALOPERIDOL 2MG TABLET / ORAL AB 1987-02-17 8072bd15b7f6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 64 observed states.
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 · 2 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 35573-440-02 35573044002 100 TABLET in 1 BOTTLE (35573-440-02) 100 tablet 2021-05-31 0000-00-00 No No Current