Home NDC 72789-568 Haloperidol
Product NDC 72789-568
11-digit product format 727890568
Labeler code 72789
Product ID 72789-568_50221596-087a-9973-e063-6394a90ae95f
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Haloperidol
Dosage form TABLET
Route ORAL
Labeler PD-Rx Pharmaceuticals, Inc.
Application ANDA071130
Marketing category ANDA
Marketing start 2026-04-08
Substance HALOPERIDOL
Active strength 2 mg/1
Pharmacologic classes Typical Antipsychotic [EPC]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
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 A071130-001 HALOPERIDOL HALOPERIDOL 2MG TABLET / ORAL AB 1987-02-17 A071130-002 HALOPERIDOL HALOPERIDOL 5MG TABLET / ORAL AB 1987-02-17 A071130-003 HALOPERIDOL HALOPERIDOL 10MG TABLET / ORAL AB 1987-05-12 A071130-004 HALOPERIDOL HALOPERIDOL 0.5MG TABLET / ORAL AB 2026-04-08 A071130-005 HALOPERIDOL HALOPERIDOL 1MG TABLET / ORAL AB 2026-04-08 A071130-006 HALOPERIDOL HALOPERIDOL 20MG TABLET / ORAL AB 2026-04-08
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 6 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 3 · 90 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 2026-10-15 13:18:30 2026-09 A071130-001 HALOPERIDOL 2MG TABLET / ORAL AB 1987-02-17 c2088c7a36db…2026-10-15 13:18:30 2026-09 A071130-002 HALOPERIDOL 5MG TABLET / ORAL AB 1987-02-17 c2088c7a36db…2026-10-15 13:18:30 2026-09 A071130-003 HALOPERIDOL 10MG TABLET / ORAL AB 1987-05-12 c2088c7a36db…2026-10-15 13:18:30 2026-09 A071130-004 HALOPERIDOL 0.5MG TABLET / ORAL AB 2026-04-08 c2088c7a36db…2026-10-15 13:18:30 2026-09 A071130-005 HALOPERIDOL 1MG TABLET / ORAL AB 2026-04-08 c2088c7a36db…2026-10-15 13:18:30 2026-09 A071130-006 HALOPERIDOL 20MG TABLET / ORAL AB 2026-04-08 c2088c7a36db…2026-09-14 22:38:34 2026-08 A071130-001 HALOPERIDOL 2MG TABLET / ORAL AB 1987-02-17 84e616aacf4f…2026-09-14 22:38:34 2026-08 A071130-002 HALOPERIDOL 5MG TABLET / ORAL AB 1987-02-17 84e616aacf4f…2026-09-14 22:38:34 2026-08 A071130-003 HALOPERIDOL 10MG TABLET / ORAL AB 1987-05-12 84e616aacf4f…2026-09-14 22:38:34 2026-08 A071130-004 HALOPERIDOL 0.5MG TABLET / ORAL AB 2026-04-08 84e616aacf4f…2026-09-14 22:38:34 2026-08 A071130-005 HALOPERIDOL 1MG TABLET / ORAL AB 2026-04-08 84e616aacf4f…2026-09-14 22:38:34 2026-08 A071130-006 HALOPERIDOL 20MG TABLET / ORAL AB 2026-04-08 84e616aacf4f…2026-08-18 06:07:40 2026-07 A071130-001 HALOPERIDOL 2MG TABLET / ORAL AB 1987-02-17 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A071130-002 HALOPERIDOL 5MG TABLET / ORAL AB 1987-02-17 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A071130-003 HALOPERIDOL 10MG TABLET / ORAL AB 1987-05-12 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A071130-004 HALOPERIDOL 0.5MG TABLET / ORAL AB 2026-04-08 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A071130-005 HALOPERIDOL 1MG TABLET / ORAL AB 2026-04-08 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A071130-006 HALOPERIDOL 20MG TABLET / ORAL AB 2026-04-08 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A071130-001 HALOPERIDOL 2MG TABLET / ORAL AB 1987-02-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A071130-002 HALOPERIDOL 5MG TABLET / ORAL AB 1987-02-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A071130-003 HALOPERIDOL 10MG TABLET / ORAL AB 1987-05-12 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A071130-001 HALOPERIDOL 2MG TABLET / ORAL AB 1987-02-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A071130-002 HALOPERIDOL 5MG TABLET / ORAL AB 1987-02-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A071130-003 HALOPERIDOL 10MG TABLET / ORAL AB 1987-05-12 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A071130-001 HALOPERIDOL 2MG TABLET / ORAL AB 1987-02-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A071130-002 HALOPERIDOL 5MG TABLET / ORAL AB 1987-02-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A071130-003 HALOPERIDOL 10MG TABLET / ORAL AB 1987-05-12 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A071130-001 HALOPERIDOL 2MG TABLET / ORAL AB 1987-02-17 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A071130-002 HALOPERIDOL 5MG TABLET / ORAL AB 1987-02-17 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A071130-003 HALOPERIDOL 10MG TABLET / ORAL AB 1987-05-12 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A071130-001 HALOPERIDOL 2MG TABLET / ORAL AB 1987-02-17 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A071130-002 HALOPERIDOL 5MG TABLET / ORAL AB 1987-02-17 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A071130-003 HALOPERIDOL 10MG TABLET / ORAL AB 1987-05-12 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A071130-001 HALOPERIDOL 2MG TABLET / ORAL AB 1987-02-17 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A071130-002 HALOPERIDOL 5MG TABLET / ORAL AB 1987-02-17 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A071130-003 HALOPERIDOL 10MG TABLET / ORAL AB 1987-05-12 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A071130-001 HALOPERIDOL 2MG TABLET / ORAL AB 1987-02-17 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A071130-002 HALOPERIDOL 5MG TABLET / ORAL AB 1987-02-17 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A071130-003 HALOPERIDOL 10MG TABLET / ORAL AB 1987-05-12 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A071130-001 HALOPERIDOL 2MG TABLET / ORAL AB 1987-02-17 5bbf6a4d5a75…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 82 observed states.
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 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength HALOPERIDOL 2 mg/1
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 · 6 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 197754 Internal RxNorm lookup 310670 Internal RxNorm lookup 310671 Internal RxNorm lookup 310672 Internal RxNorm lookup 314034 Internal RxNorm lookup 314035 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 72789-568-01 Haloperidol 100 in 1 BOTTLE, PLASTIC TABLET 100 2
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 Sample Exclude flag Status 72789-568-01 72789056801 100 TABLET in 1 BOTTLE, PLASTIC (72789-568-01) 100 tablet 2026-04-22 No No Current