Home NDC 17856-0501-1 Haloperidol
Product NDC 17856-0501
Requested package NDC 17856-0501-1
11-digit product format 178560501
Labeler code 17856
Product ID 17856-0501_86053e77-056c-40db-9d08-2411c6ec1abc
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Haloperidol
Dosage form SOLUTION
Route ORAL
Labeler ATLANTIC BIOLOGICALS CORP.
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 2021-12-31
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 · 18 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…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 1332a3947898…d4bfe170f9cd…2022-08-30 03:57 UTC · source 2022-08-29 fb8cb913e6d1…eb8c232b6be0…2022-04-09 23:13 UTC · source 2022-04-08 86f5da6cb304…a595104c45d7…2022-04-04 05:40 UTC · source 2022-04-01 bd6a592717d7…303034d00443…
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# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 17856-0501-1 Haloperidol 72 in 1 BOX, UNIT-DOSE SOLUTION 72 1 17856-0501-1 Haloperidol 5 mL in 1 CUP, UNIT-DOSE SOLUTION 5 1 17856-0501-4 Haloperidol 4 mL in 1 CUP, UNIT-DOSE SOLUTION 4 1 17856-0501-4 Haloperidol 72 in 1 BOX, UNIT-DOSE SOLUTION 72 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 17856-0501 HALOPERIDOL SOLUTION [ATLANTIC BIOLOGICALS CORP.] 1 Legacy NDC, 4 package rows 20200731_3766e48c-4bd3-448c-a526-06a347ea8f5a.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
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 17856-0501-1 17856050101 72 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (17856-0501-1) > 5 mL in 1 CUP, UNIT-DOSE 2020-07-30 0000-00-00 No No Current