Home NDC 0904-7112 Haloperidol
Product NDC 0904-7112
11-digit product format 009047112
Labeler code 0904
Product ID 0904-7112_eadcea92-7ca6-4bd8-b4e5-f59bf44f3385
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Haloperidol
Dosage form SOLUTION
Route ORAL
Labeler Major Pharmaceuticals
Application ANDA073364
Marketing category ANDA
Marketing start 1993-09-28
Marketing end 0000-00-00
Substance HALOPERIDOL LACTATE
Active strength 2 mg/mL
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 · 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 product product 0904-7112 D Discontinued by firm excluded / ndc_excluded.zip d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 0904-7112 0904-7112-70 D Discontinued by firm excluded / ndc_excluded.zip d630ba8d3edf…732f749b63fb…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A073364-001 HALOPERIDOL HALOPERIDOL LACTATE EQ 2MG BASE/ML CONCENTRATE / ORAL AA 1993-09-28
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A073364-001 AA
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 · 42 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 A073364-001 HALOPERIDOL EQ 2MG BASE/ML CONCENTRATE / ORAL AA 1993-09-28 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A073364-001 HALOPERIDOL EQ 2MG BASE/ML CONCENTRATE / ORAL AA 1993-09-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A073364-001 HALOPERIDOL EQ 2MG BASE/ML CONCENTRATE / ORAL AA 1993-09-28 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A073364-001 HALOPERIDOL EQ 2MG BASE/ML CONCENTRATE / ORAL AA 1993-09-28 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A073364-001 HALOPERIDOL EQ 2MG BASE/ML CONCENTRATE / ORAL AA 1993-09-28 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A073364-001 HALOPERIDOL EQ 2MG BASE/ML CONCENTRATE / ORAL AA 1993-09-28 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A073364-001 HALOPERIDOL EQ 2MG BASE/ML CONCENTRATE / ORAL AA 1993-09-28 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A073364-001 HALOPERIDOL EQ 2MG BASE/ML CONCENTRATE / ORAL AA 1993-09-28 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A073364-001 HALOPERIDOL EQ 2MG BASE/ML CONCENTRATE / ORAL AA 1993-09-28 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A073364-001 HALOPERIDOL EQ 2MG BASE/ML CONCENTRATE / ORAL AA 1993-09-28 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A073364-001 HALOPERIDOL EQ 2MG BASE/ML CONCENTRATE / ORAL AA 1993-09-28 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A073364-001 HALOPERIDOL EQ 2MG BASE/ML CONCENTRATE / ORAL AA 1993-09-28 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A073364-001 HALOPERIDOL EQ 2MG BASE/ML CONCENTRATE / ORAL AA 1993-09-28 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A073364-001 HALOPERIDOL EQ 2MG BASE/ML CONCENTRATE / ORAL AA 1993-09-28 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A073364-001 HALOPERIDOL EQ 2MG BASE/ML CONCENTRATE / ORAL AA 1993-09-28 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A073364-001 HALOPERIDOL EQ 2MG BASE/ML CONCENTRATE / ORAL AA 1993-09-28 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A073364-001 HALOPERIDOL EQ 2MG BASE/ML CONCENTRATE / ORAL AA 1993-09-28 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A073364-001 HALOPERIDOL EQ 2MG BASE/ML CONCENTRATE / ORAL AA 1993-09-28 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A073364-001 HALOPERIDOL EQ 2MG BASE/ML CONCENTRATE / ORAL AA 1993-09-28 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A073364-001 HALOPERIDOL EQ 2MG BASE/ML CONCENTRATE / ORAL AA 1993-09-28 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A073364-001 HALOPERIDOL EQ 2MG BASE/ML CONCENTRATE / ORAL AA 1993-09-28 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A073364-001 HALOPERIDOL EQ 2MG BASE/ML CONCENTRATE / ORAL AA 1993-09-28 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A073364-001 HALOPERIDOL EQ 2MG BASE/ML CONCENTRATE / ORAL AA 1993-09-28 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A073364-001 HALOPERIDOL EQ 2MG BASE/ML CONCENTRATE / ORAL AA 1993-09-28 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A073364-001 HALOPERIDOL EQ 2MG BASE/ML CONCENTRATE / ORAL AA 1993-09-28 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A073364-001 HALOPERIDOL EQ 2MG BASE/ML CONCENTRATE / ORAL AA 1993-09-28 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A073364-001 HALOPERIDOL EQ 2MG BASE/ML CONCENTRATE / ORAL AA 1993-09-28 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A073364-001 HALOPERIDOL EQ 2MG BASE/ML CONCENTRATE / ORAL AA 1993-09-28 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A073364-001 HALOPERIDOL EQ 2MG BASE/ML CONCENTRATE / ORAL AA 1993-09-28 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A073364-001 HALOPERIDOL EQ 2MG BASE/ML CONCENTRATE / ORAL AA 1993-09-28 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A073364-001 HALOPERIDOL EQ 2MG BASE/ML CONCENTRATE / ORAL AA 1993-09-28 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A073364-001 HALOPERIDOL EQ 2MG BASE/ML CONCENTRATE / ORAL AA 1993-09-28 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A073364-001 HALOPERIDOL EQ 2MG BASE/ML CONCENTRATE / ORAL AA 1993-09-28 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A073364-001 HALOPERIDOL EQ 2MG BASE/ML CONCENTRATE / ORAL AA 1993-09-28 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A073364-001 HALOPERIDOL EQ 2MG BASE/ML CONCENTRATE / ORAL AA 1993-09-28 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A073364-001 HALOPERIDOL EQ 2MG BASE/ML CONCENTRATE / ORAL AA 1993-09-28 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A073364-001 HALOPERIDOL EQ 2MG BASE/ML CONCENTRATE / ORAL AA 1993-09-28 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A073364-001 HALOPERIDOL EQ 2MG BASE/ML CONCENTRATE / ORAL AA 1993-09-28 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A073364-001 HALOPERIDOL EQ 2MG BASE/ML CONCENTRATE / ORAL AA 1993-09-28 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A073364-001 HALOPERIDOL EQ 2MG BASE/ML CONCENTRATE / ORAL AA 1993-09-28 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
DailyMed Product Concepts# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0904-7112 HALOPERIDOL SOLUTION [MAJOR PHARMACEUTICALS] 4 Legacy NDC 20241222_bd618699-a635-4c36-8048-fc2efa98840a.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 Lannett Company, Inc. 3e44fed0-6132-4881-a9cd-af6156c7af9c 2024-11-13 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 073364 application number: ANDA073364
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0904-7112-70 00904711270 5 mL in 1 CUP, UNIT-DOSE (0904-7112-70) 5 ml 1993-09-28 0000-00-00 No No Current