Home NDC 63187-842-90 Haloperidol
Product NDC 63187-842
Requested package NDC 63187-842-90
11-digit product format 631870842
Labeler code 63187
Product ID 63187-842_2274db0b-42a3-484e-941c-990bad99df65
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Haloperidol
Dosage form TABLET
Route ORAL
Labeler Proficient Rx LP
Application ANDA071209
Marketing category ANDA
Marketing start 1986-11-17
Marketing end 0000-00-00
Substance HALOPERIDOL
Active strength 5 mg/1
Pharmacologic classes Typical Antipsychotic [EPC]
NDC exclude flag No
Listing certified through 2020-12-31
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 · 2 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 63187-842 63187-842-90 D Discontinued by firm excluded / ndc_excluded.zip d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 63187-842 63187-842-90 D Discontinued by firm excluded / ndc_excluded.zip f5e01cc5f278…a2eaf40c39c3…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 4 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A071209-001 HALOPERIDOL HALOPERIDOL 5MG TABLET / ORAL AB 1986-11-17 A071209-002 HALOPERIDOL HALOPERIDOL 0.5MG TABLET / ORAL AB 1986-11-17 A071209-003 HALOPERIDOL HALOPERIDOL 1MG TABLET / ORAL AB 1986-11-17 A071209-004 HALOPERIDOL HALOPERIDOL 2MG TABLET / ORAL 1986-11-17
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 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 4 · 135 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 A071209-001 HALOPERIDOL 5MG TABLET / ORAL AB 1986-11-17 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A071209-002 HALOPERIDOL 0.5MG TABLET / ORAL AB 1986-11-17 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A071209-003 HALOPERIDOL 1MG TABLET / ORAL AB 1986-11-17 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A071209-004 HALOPERIDOL 2MG TABLET / ORAL 1986-11-17 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A071209-001 HALOPERIDOL 5MG TABLET / ORAL AB 1986-11-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A071209-002 HALOPERIDOL 0.5MG TABLET / ORAL AB 1986-11-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A071209-003 HALOPERIDOL 1MG TABLET / ORAL AB 1986-11-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A071209-004 HALOPERIDOL 2MG TABLET / ORAL 1986-11-17 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A071209-001 HALOPERIDOL 5MG TABLET / ORAL AB 1986-11-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A071209-002 HALOPERIDOL 0.5MG TABLET / ORAL AB 1986-11-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A071209-003 HALOPERIDOL 1MG TABLET / ORAL AB 1986-11-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A071209-004 HALOPERIDOL 2MG TABLET / ORAL 1986-11-17 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A071209-001 HALOPERIDOL 5MG TABLET / ORAL AB 1986-11-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A071209-002 HALOPERIDOL 0.5MG TABLET / ORAL AB 1986-11-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A071209-003 HALOPERIDOL 1MG TABLET / ORAL AB 1986-11-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A071209-004 HALOPERIDOL 2MG TABLET / ORAL 1986-11-17 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A071209-001 HALOPERIDOL 5MG TABLET / ORAL AB 1986-11-17 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A071209-002 HALOPERIDOL 0.5MG TABLET / ORAL AB 1986-11-17 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A071209-003 HALOPERIDOL 1MG TABLET / ORAL AB 1986-11-17 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A071209-004 HALOPERIDOL 2MG TABLET / ORAL 1986-11-17 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A071209-001 HALOPERIDOL 5MG TABLET / ORAL AB 1986-11-17 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A071209-002 HALOPERIDOL 0.5MG TABLET / ORAL AB 1986-11-17 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A071209-003 HALOPERIDOL 1MG TABLET / ORAL AB 1986-11-17 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A071209-004 HALOPERIDOL 2MG TABLET / ORAL 1986-11-17 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A071209-001 HALOPERIDOL 5MG TABLET / ORAL AB 1986-11-17 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A071209-002 HALOPERIDOL 0.5MG TABLET / ORAL AB 1986-11-17 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A071209-003 HALOPERIDOL 1MG TABLET / ORAL AB 1986-11-17 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A071209-004 HALOPERIDOL 2MG TABLET / ORAL 1986-11-17 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A071209-001 HALOPERIDOL 5MG TABLET / ORAL AB 1986-11-17 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A071209-002 HALOPERIDOL 0.5MG TABLET / ORAL AB 1986-11-17 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A071209-003 HALOPERIDOL 1MG TABLET / ORAL AB 1986-11-17 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A071209-004 HALOPERIDOL 2MG TABLET / ORAL 1986-11-17 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A071209-001 HALOPERIDOL 5MG TABLET / ORAL AB 1986-11-17 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A071209-002 HALOPERIDOL 0.5MG TABLET / ORAL AB 1986-11-17 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A071209-003 HALOPERIDOL 1MG TABLET / ORAL AB 1986-11-17 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A071209-004 HALOPERIDOL 2MG TABLET / ORAL 1986-11-17 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A071209-001 HALOPERIDOL 5MG TABLET / ORAL AB 1986-11-17 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A071209-002 HALOPERIDOL 0.5MG TABLET / ORAL AB 1986-11-17 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A071209-003 HALOPERIDOL 1MG TABLET / ORAL AB 1986-11-17 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A071209-004 HALOPERIDOL 2MG TABLET / ORAL 1986-11-17 d8e5a09893c0…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 104 observed states.
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63187-842 HALOPERIDOL TABLET [PROFICIENT RX LP] 3 Legacy NDC 20191113_e5c28155-a7a5-4d1e-aae5-99408b5f457c.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 63187-842-90 63187084290 90 TABLET in 1 BOTTLE (63187-842-90) 90 tablet 2017-05-01 0000-00-00 No No Current