Home NDC 0121-0581 Haloperidol
Product NDC 0121-0581
11-digit product format 001210581
Labeler code 0121
Product ID 0121-0581_0f6d8b89-8c33-4459-84af-e588eb27587c
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Haloperidol
Dosage form SOLUTION
Route ORAL
Labeler PAI Holdings, LLC dba PAI Pharma
Application ANDA073037
Marketing category ANDA
Marketing start 2009-11-10
Substance HALOPERIDOL
Active strength 2 mg/mL
Pharmacologic classes Typical Antipsychotic [EPC]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
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 A073037-001 HALOPERIDOL HALOPERIDOL LACTATE EQ 2MG BASE/ML CONCENTRATE / ORAL AA RS 1993-02-26
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A073037-001 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 · 41 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 A073037-001 HALOPERIDOL EQ 2MG BASE/ML CONCENTRATE / ORAL AA RS 1993-02-26 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A073037-001 HALOPERIDOL EQ 2MG BASE/ML CONCENTRATE / ORAL AA RS 1993-02-26 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A073037-001 HALOPERIDOL EQ 2MG BASE/ML CONCENTRATE / ORAL AA RS 1993-02-26 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A073037-001 HALOPERIDOL EQ 2MG BASE/ML CONCENTRATE / ORAL AA RS 1993-02-26 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A073037-001 HALOPERIDOL EQ 2MG BASE/ML CONCENTRATE / ORAL AA RS 1993-02-26 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A073037-001 HALOPERIDOL EQ 2MG BASE/ML CONCENTRATE / ORAL AA RS 1993-02-26 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A073037-001 HALOPERIDOL EQ 2MG BASE/ML CONCENTRATE / ORAL AA RS 1993-02-26 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A073037-001 HALOPERIDOL EQ 2MG BASE/ML CONCENTRATE / ORAL AA RS 1993-02-26 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A073037-001 HALOPERIDOL EQ 2MG BASE/ML CONCENTRATE / ORAL AA RS 1993-02-26 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A073037-001 HALOPERIDOL EQ 2MG BASE/ML CONCENTRATE / ORAL AA RS 1993-02-26 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A073037-001 HALOPERIDOL EQ 2MG BASE/ML CONCENTRATE / ORAL AA RS 1993-02-26 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A073037-001 HALOPERIDOL EQ 2MG BASE/ML CONCENTRATE / ORAL AA RS 1993-02-26 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A073037-001 HALOPERIDOL EQ 2MG BASE/ML CONCENTRATE / ORAL AA RS 1993-02-26 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A073037-001 HALOPERIDOL EQ 2MG BASE/ML CONCENTRATE / ORAL AA RS 1993-02-26 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A073037-001 HALOPERIDOL EQ 2MG BASE/ML CONCENTRATE / ORAL AA RS 1993-02-26 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A073037-001 HALOPERIDOL EQ 2MG BASE/ML CONCENTRATE / ORAL AA RS 1993-02-26 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A073037-001 HALOPERIDOL EQ 2MG BASE/ML CONCENTRATE / ORAL AA RS 1993-02-26 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A073037-001 HALOPERIDOL EQ 2MG BASE/ML CONCENTRATE / ORAL AA RS 1993-02-26 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A073037-001 HALOPERIDOL EQ 2MG BASE/ML CONCENTRATE / ORAL AA RS 1993-02-26 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A073037-001 HALOPERIDOL EQ 2MG BASE/ML CONCENTRATE / ORAL AA RS 1993-02-26 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A073037-001 HALOPERIDOL EQ 2MG BASE/ML CONCENTRATE / ORAL AA RS 1993-02-26 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A073037-001 HALOPERIDOL EQ 2MG BASE/ML CONCENTRATE / ORAL AA RS 1993-02-26 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A073037-001 HALOPERIDOL EQ 2MG BASE/ML CONCENTRATE / ORAL AA RS 1993-02-26 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A073037-001 HALOPERIDOL EQ 2MG BASE/ML CONCENTRATE / ORAL AA RS 1993-02-26 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A073037-001 HALOPERIDOL EQ 2MG BASE/ML CONCENTRATE / ORAL AA RS 1993-02-26 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A073037-001 HALOPERIDOL EQ 2MG BASE/ML CONCENTRATE / ORAL AA RS 1993-02-26 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A073037-001 HALOPERIDOL EQ 2MG BASE/ML CONCENTRATE / ORAL AA RS 1993-02-26 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A073037-001 HALOPERIDOL EQ 2MG BASE/ML CONCENTRATE / ORAL AA RS 1993-02-26 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A073037-001 HALOPERIDOL EQ 2MG BASE/ML CONCENTRATE / ORAL AA RS 1993-02-26 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A073037-001 HALOPERIDOL EQ 2MG BASE/ML CONCENTRATE / ORAL AA RS 1993-02-26 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A073037-001 HALOPERIDOL EQ 2MG BASE/ML CONCENTRATE / ORAL AA RS 1993-02-26 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A073037-001 HALOPERIDOL EQ 2MG BASE/ML CONCENTRATE / ORAL AA RS 1993-02-26 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A073037-001 HALOPERIDOL EQ 2MG BASE/ML CONCENTRATE / ORAL AA RS 1993-02-26 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A073037-001 HALOPERIDOL EQ 2MG BASE/ML CONCENTRATE / ORAL AA RS 1993-02-26 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A073037-001 HALOPERIDOL EQ 2MG BASE/ML CONCENTRATE / ORAL AA RS 1993-02-26 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A073037-001 HALOPERIDOL EQ 2MG BASE/ML CONCENTRATE / ORAL AA RS 1993-02-26 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A073037-001 HALOPERIDOL EQ 2MG BASE/ML CONCENTRATE / ORAL AA RS 1993-02-26 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A073037-001 HALOPERIDOL EQ 2MG BASE/ML CONCENTRATE / ORAL AA RS 1993-02-26 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A073037-001 HALOPERIDOL EQ 2MG BASE/ML CONCENTRATE / ORAL AA RS 1993-02-26 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A073037-001 HALOPERIDOL EQ 2MG BASE/ML CONCENTRATE / ORAL AA RS 1993-02-26 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Haloperidol
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength HALOPERIDOL 2 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination J6292F8L3D Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 141935 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0121-0581-04 Haloperidol 120 mL in 1 BOTTLE SOLUTION 120 15 0121-0581-05 Haloperidol 10 in 1 CASE SOLUTION 10 15 0121-0581-05 Haloperidol 10 in 1 TRAY SOLUTION 10 15 0121-0581-15 Haloperidol 15 mL in 1 BOTTLE SOLUTION 15 15
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0121-0581 HALOPERIDOL SOLUTION [PAI HOLDINGS, LLC DBA PAI PHARMA] 15 Current NDC, Legacy NDC, 4 package rows 20250210_b488c106-f1ee-4b7b-8516-01162fb929f7.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 · 2 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0121-0581-04 00121058104 120 mL in 1 BOTTLE (0121-0581-04) 120 ml 2009-11-10 0000-00-00 No No Current 0121-0581-05 00121058105 10 TRAY in 1 CASE (0121-0581-05) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE 10 tray 2009-11-10 0000-00-00 No No Current 0121-0581-15 00121058115 15 mL in 1 BOTTLE (0121-0581-15) 15 ml 2020-06-12 0000-00-00 No No Current