Home NDC 53808-0264 Haloperidol
Product NDC 53808-0264
11-digit product format 538080264
Labeler code 53808
Product ID 53808-0264_3cf84e3a-2a50-4d72-9461-ffd9c78bd244
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name haloperidol
Dosage form TABLET
Route ORAL
Labeler State of Florida DOH Central Pharmacy
Application ANDA070278
Marketing category ANDA
Marketing start 2009-07-01
Marketing end 0000-00-00
Substance HALOPERIDOL
Active strength 5 mg/1
Pharmacologic classes Typical Antipsychotic [EPC]
NDC exclude flag E
Listing certified through 2017-12-31
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 · 44 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 53808-0264-1 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 53808-0264-1 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 53808-0264-1 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 53808-0264-1 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 53808-0264-1 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 53808-0264-1 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 53808-0264-1 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 53808-0264-1 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 53808-0264-1 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 53808-0264-1 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 53808-0264-1 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 53808-0264-1 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 excluded product product 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 53808-0264-1 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 excluded product product 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 53808-0264-1 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 excluded product product 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 53808-0264-1 1332a3947898…d4bfe170f9cd…2022-08-30 03:57 UTC · source 2022-08-29 excluded product product fb8cb913e6d1…eb8c232b6be0…2022-08-30 03:57 UTC · source 2022-08-29 excluded package package 53808-0264-1 fb8cb913e6d1…eb8c232b6be0…2022-04-09 23:13 UTC · source 2022-04-08 excluded product product 86f5da6cb304…a595104c45d7…2022-04-09 23:13 UTC · source 2022-04-08 excluded package package 53808-0264-1 86f5da6cb304…a595104c45d7…2022-04-04 05:40 UTC · source 2022-04-01 excluded product product bd6a592717d7…303034d00443…2022-04-04 05:40 UTC · source 2022-04-01 excluded package package 53808-0264-1 bd6a592717d7…303034d00443…2021-12-27 23:28 UTC · source 2021-12-27 excluded product product 8dfbde2a14a4…c9ff85d89658…2021-12-27 23:28 UTC · source 2021-12-27 excluded package package 53808-0264-1 8dfbde2a14a4…c9ff85d89658…2020-12-18 03:04 UTC · source 2020-12-17 excluded product product e2bbac7714bc…27bdfed8d636…2020-12-18 03:04 UTC · source 2020-12-17 excluded package package 53808-0264-1 e2bbac7714bc…27bdfed8d636…2020-06-10 20:45 UTC · source 2020-06-10 excluded product product 9bebd1f3094a…5416666fcb17…2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 53808-0264-1 9bebd1f3094a…5416666fcb17…2019-12-08 06:16 UTC · source 2019-12-05 excluded product product 110d247fa046…a55b01930146…2019-12-08 06:16 UTC · source 2019-12-05 excluded package package 53808-0264-1 110d247fa046…a55b01930146…
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 A070278-001 HALOPERIDOL HALOPERIDOL 2MG TABLET / ORAL AB RS 1986-06-10 A070278-002 HALOPERIDOL HALOPERIDOL 10MG TABLET / ORAL AB 2009-07-16 A070278-003 HALOPERIDOL HALOPERIDOL 20MG TABLET / ORAL 2009-07-16 A070278-004 HALOPERIDOL HALOPERIDOL 1MG TABLET / ORAL AB 1986-06-10 A070278-005 HALOPERIDOL HALOPERIDOL 5MG TABLET / ORAL AB 1986-06-10 A070278-006 HALOPERIDOL HALOPERIDOL 0.5MG TABLET / ORAL AB 1986-06-10
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 5 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 7 · 246 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 A070278-001 HALOPERIDOL 2MG TABLET / ORAL AB RS 1986-06-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A070278-002 HALOPERIDOL 10MG TABLET / ORAL AB 2009-07-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A070278-003 HALOPERIDOL 20MG TABLET / ORAL AB 2009-07-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A070278-004 HALOPERIDOL 1MG TABLET / ORAL AB 1986-06-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A070278-005 HALOPERIDOL 5MG TABLET / ORAL AB 1986-06-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A070278-006 HALOPERIDOL 0.5MG TABLET / ORAL AB 1986-06-10 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A070278-001 HALOPERIDOL 2MG TABLET / ORAL AB RS 1986-06-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A070278-002 HALOPERIDOL 10MG TABLET / ORAL AB 2009-07-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A070278-003 HALOPERIDOL 20MG TABLET / ORAL AB 2009-07-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A070278-004 HALOPERIDOL 1MG TABLET / ORAL AB 1986-06-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A070278-005 HALOPERIDOL 5MG TABLET / ORAL AB 1986-06-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A070278-006 HALOPERIDOL 0.5MG TABLET / ORAL AB 1986-06-10 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A070278-001 HALOPERIDOL 2MG TABLET / ORAL AB RS 1986-06-10 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A070278-002 HALOPERIDOL 10MG TABLET / ORAL AB 2009-07-16 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A070278-003 HALOPERIDOL 20MG TABLET / ORAL AB 2009-07-16 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A070278-004 HALOPERIDOL 1MG TABLET / ORAL AB 1986-06-10 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A070278-005 HALOPERIDOL 5MG TABLET / ORAL AB 1986-06-10 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A070278-006 HALOPERIDOL 0.5MG TABLET / ORAL AB 1986-06-10 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A070278-001 HALOPERIDOL 2MG TABLET / ORAL AB RS 1986-06-10 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A070278-002 HALOPERIDOL 10MG TABLET / ORAL AB 2009-07-16 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A070278-003 HALOPERIDOL 20MG TABLET / ORAL AB 2009-07-16 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A070278-004 HALOPERIDOL 1MG TABLET / ORAL AB 1986-06-10 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A070278-005 HALOPERIDOL 5MG TABLET / ORAL AB 1986-06-10 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A070278-006 HALOPERIDOL 0.5MG TABLET / ORAL AB 1986-06-10 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A070278-001 HALOPERIDOL 2MG TABLET / ORAL AB RS 1986-06-10 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A070278-002 HALOPERIDOL 10MG TABLET / ORAL AB 2009-07-16 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A070278-003 HALOPERIDOL 20MG TABLET / ORAL AB 2009-07-16 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A070278-004 HALOPERIDOL 1MG TABLET / ORAL AB 1986-06-10 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A070278-005 HALOPERIDOL 5MG TABLET / ORAL AB 1986-06-10 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A070278-006 HALOPERIDOL 0.5MG TABLET / ORAL AB 1986-06-10 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A070278-001 HALOPERIDOL 2MG TABLET / ORAL AB RS 1986-06-10 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A070278-002 HALOPERIDOL 10MG TABLET / ORAL AB 2009-07-16 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A070278-003 HALOPERIDOL 20MG TABLET / ORAL AB 2009-07-16 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A070278-004 HALOPERIDOL 1MG TABLET / ORAL AB 1986-06-10 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A070278-005 HALOPERIDOL 5MG TABLET / ORAL AB 1986-06-10 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A070278-006 HALOPERIDOL 0.5MG TABLET / ORAL AB 1986-06-10 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A070278-001 HALOPERIDOL 2MG TABLET / ORAL AB RS 1986-06-10 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A070278-002 HALOPERIDOL 10MG TABLET / ORAL AB 2009-07-16 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A070278-003 HALOPERIDOL 20MG TABLET / ORAL AB 2009-07-16 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A070278-004 HALOPERIDOL 1MG TABLET / ORAL AB 1986-06-10 2680178bc6a6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 7 · 241 observed states.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 53808-0264-1 Haloperidol 30 in 1 BLISTER PACK TABLET 30 1
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 53808-0264 HALOPERIDOL TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 Legacy NDC, 1 package rows 20100614_82305b49-9fdf-425b-98d7-39c2ac156918.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 · 4 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Haloperidol HALOPERIDOL Cardinal Health 107, LLC 8ca14b79-6671-4e44-aa34-6564a92aa197 2025-10-14 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 070278 application number: ANDA070278 Haloperidol HALOPERIDOL Mylan Institutional Inc. ad7d2f17-a4e8-4ebc-9baf-5983ac626782 2025-09-02 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 070278 application number: ANDA070278 Haloperidol HALOPERIDOL Coupler LLC 2ccc2e26-de98-af81-e063-6394a90a040b 2025-01-28 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 070278 application number: ANDA070278 Haloperidol HALOPERIDOL Mylan Pharmaceuticals Inc. c559b0b0-4087-d12a-e718-c18ccb6811e6 2025-01-15 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 070278 application number: ANDA070278
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Status 53808-0264-1 53808026401 30 in 1 BLISTER PACK Historical