Home NDC 72888-173 Haloperidol
Product NDC 72888-173
11-digit product format 728880173
Labeler code 72888
Product ID 72888-173_45c7bbb4-7235-89a8-e063-6394a90a7ea0
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Haloperidol
Dosage form SOLUTION, CONCENTRATE
Route ORAL
Labeler Advagen Pharma Ltd
Application ANDA218371
Marketing category ANDA
Marketing start 2024-01-31
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 43 .
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 A218371-001 HALOPERIDOL HALOPERIDOL LACTATE EQ 2MG BASE/ML CONCENTRATE / ORAL AA 2024-01-31
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A218371-001 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.
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 2026-09-14 22:38:34 2026-08 A218371-001 HALOPERIDOL EQ 2MG BASE/ML CONCENTRATE / ORAL AA 2024-01-31 84e616aacf4f…2026-08-18 06:07:40 2026-07 A218371-001 HALOPERIDOL EQ 2MG BASE/ML CONCENTRATE / ORAL AA 2024-01-31 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A218371-001 HALOPERIDOL EQ 2MG BASE/ML CONCENTRATE / ORAL AA 2024-01-31 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A218371-001 HALOPERIDOL EQ 2MG BASE/ML CONCENTRATE / ORAL AA 2024-01-31 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A218371-001 HALOPERIDOL EQ 2MG BASE/ML CONCENTRATE / ORAL AA 2024-01-31 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A218371-001 HALOPERIDOL EQ 2MG BASE/ML CONCENTRATE / ORAL AA 2024-01-31 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A218371-001 HALOPERIDOL EQ 2MG BASE/ML CONCENTRATE / ORAL AA 2024-01-31 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A218371-001 HALOPERIDOL EQ 2MG BASE/ML CONCENTRATE / ORAL AA 2024-01-31 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A218371-001 HALOPERIDOL EQ 2MG BASE/ML CONCENTRATE / ORAL AA 2024-01-31 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A218371-001 HALOPERIDOL EQ 2MG BASE/ML CONCENTRATE / ORAL AA 2024-01-31 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A218371-001 HALOPERIDOL EQ 2MG BASE/ML CONCENTRATE / ORAL AA 2024-01-31 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A218371-001 HALOPERIDOL EQ 2MG BASE/ML CONCENTRATE / ORAL AA 2024-01-31 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A218371-001 HALOPERIDOL EQ 2MG BASE/ML CONCENTRATE / ORAL AA 2024-01-31 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A218371-001 HALOPERIDOL EQ 2MG BASE/ML CONCENTRATE / ORAL AA 2024-01-31 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A218371-001 HALOPERIDOL EQ 2MG BASE/ML CONCENTRATE / ORAL AA 2024-01-31 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A218371-001 HALOPERIDOL EQ 2MG BASE/ML CONCENTRATE / ORAL AA 2024-01-31 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A218371-001 HALOPERIDOL EQ 2MG BASE/ML CONCENTRATE / ORAL AA 2024-01-31 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A218371-001 HALOPERIDOL EQ 2MG BASE/ML CONCENTRATE / ORAL AA 2024-01-31 1c564ffb4f44…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218371-001 HALOPERIDOL EQ 2MG BASE/ML CONCENTRATE / ORAL AA 2024-01-31 a50c72e98297…
Observed Orange Book normalized TE history# Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
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 72888-173-47 Haloperidol 15 mL in 1 BOTTLE SOLUTION, CONCENTRATE 15 3 72888-173-48 Haloperidol 120 mL in 1 BOTTLE SOLUTION, CONCENTRATE 120 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 72888-173 HALOPERIDOL SOLUTION, CONCENTRATE [ADVAGEN PHARMA LTD] 1 Current NDC, 2 package rows 20240227_8bfdc739-51b4-4914-9a60-923e83762307.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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 72888-173-47 72888017347 15 mL in 1 BOTTLE (72888-173-47) 15 ml 2024-01-31 No No Current 72888-173-48 72888017348 120 mL in 1 BOTTLE (72888-173-48) 120 ml 2024-01-31 No No Current