Home NDC 72205-066 HALOPERIDOL
Product NDC 72205-066
11-digit product format 722050066
Labeler code 72205
Product ID 72205-066_6d0f349d-2354-4358-8fa2-5e35da47eb00
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name HALOPERIDOL
Dosage form TABLET
Route ORAL
Labeler Novadoz Pharmaceuticals LLC
Application ANDA216004
Marketing category ANDA
Marketing start 2022-11-18
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 42 .
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 A216004-001 HALOPERIDOL HALOPERIDOL 0.5MG TABLET / ORAL AB 2022-11-18 A216004-002 HALOPERIDOL HALOPERIDOL 1MG TABLET / ORAL AB 2022-11-18 A216004-003 HALOPERIDOL HALOPERIDOL 2MG TABLET / ORAL AB 2022-11-18 A216004-004 HALOPERIDOL HALOPERIDOL 5MG TABLET / ORAL AB 2022-11-18 A216004-005 HALOPERIDOL HALOPERIDOL 10MG TABLET / ORAL AB 2022-11-18 A216004-006 HALOPERIDOL HALOPERIDOL 20MG TABLET / ORAL AB 2022-11-18
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 4 · 150 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 A216004-001 HALOPERIDOL 0.5MG TABLET / ORAL AB 2022-11-18 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A216004-002 HALOPERIDOL 1MG TABLET / ORAL AB 2022-11-18 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A216004-003 HALOPERIDOL 2MG TABLET / ORAL AB 2022-11-18 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A216004-004 HALOPERIDOL 5MG TABLET / ORAL AB 2022-11-18 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A216004-005 HALOPERIDOL 10MG TABLET / ORAL AB 2022-11-18 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A216004-006 HALOPERIDOL 20MG TABLET / ORAL AB 2022-11-18 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A216004-001 HALOPERIDOL 0.5MG TABLET / ORAL AB 2022-11-18 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A216004-002 HALOPERIDOL 1MG TABLET / ORAL AB 2022-11-18 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A216004-003 HALOPERIDOL 2MG TABLET / ORAL AB 2022-11-18 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A216004-004 HALOPERIDOL 5MG TABLET / ORAL AB 2022-11-18 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A216004-005 HALOPERIDOL 10MG TABLET / ORAL AB 2022-11-18 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A216004-006 HALOPERIDOL 20MG TABLET / ORAL AB 2022-11-18 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216004-001 HALOPERIDOL 0.5MG TABLET / ORAL AB 2022-11-18 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216004-002 HALOPERIDOL 1MG TABLET / ORAL AB 2022-11-18 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216004-003 HALOPERIDOL 2MG TABLET / ORAL AB 2022-11-18 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216004-004 HALOPERIDOL 5MG TABLET / ORAL AB 2022-11-18 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216004-005 HALOPERIDOL 10MG TABLET / ORAL AB 2022-11-18 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216004-006 HALOPERIDOL 20MG TABLET / ORAL AB 2022-11-18 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A216004-001 HALOPERIDOL 0.5MG TABLET / ORAL AB 2022-11-18 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A216004-002 HALOPERIDOL 1MG TABLET / ORAL AB 2022-11-18 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A216004-003 HALOPERIDOL 2MG TABLET / ORAL AB 2022-11-18 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A216004-004 HALOPERIDOL 5MG TABLET / ORAL AB 2022-11-18 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A216004-005 HALOPERIDOL 10MG TABLET / ORAL AB 2022-11-18 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A216004-006 HALOPERIDOL 20MG TABLET / ORAL AB 2022-11-18 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A216004-001 HALOPERIDOL 0.5MG TABLET / ORAL AB 2022-11-18 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A216004-002 HALOPERIDOL 1MG TABLET / ORAL AB 2022-11-18 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A216004-003 HALOPERIDOL 2MG TABLET / ORAL AB 2022-11-18 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A216004-004 HALOPERIDOL 5MG TABLET / ORAL AB 2022-11-18 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A216004-005 HALOPERIDOL 10MG TABLET / ORAL AB 2022-11-18 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A216004-006 HALOPERIDOL 20MG TABLET / ORAL AB 2022-11-18 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A216004-001 HALOPERIDOL 0.5MG TABLET / ORAL AB 2022-11-18 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A216004-002 HALOPERIDOL 1MG TABLET / ORAL AB 2022-11-18 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A216004-003 HALOPERIDOL 2MG TABLET / ORAL AB 2022-11-18 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A216004-004 HALOPERIDOL 5MG TABLET / ORAL AB 2022-11-18 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A216004-005 HALOPERIDOL 10MG TABLET / ORAL AB 2022-11-18 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A216004-006 HALOPERIDOL 20MG TABLET / ORAL AB 2022-11-18 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A216004-001 HALOPERIDOL 0.5MG TABLET / ORAL AB 2022-11-18 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A216004-002 HALOPERIDOL 1MG TABLET / ORAL AB 2022-11-18 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A216004-003 HALOPERIDOL 2MG TABLET / ORAL AB 2022-11-18 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A216004-004 HALOPERIDOL 5MG TABLET / ORAL AB 2022-11-18 03ed91905a0d…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 150 observed states.
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 72205-066-91 HALOPERIDOL 100 in 1 BOTTLE TABLET 100 3 72205-066-99 HALOPERIDOL 1000 in 1 BOTTLE TABLET 1000 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 72205-066 HALOPERIDOL TABLET [NOVADOZ PHARMACEUTICALS LLC] 2 Current NDC, Legacy NDC, 2 package rows 20250322_3a474e06-fb00-40cb-aa3a-6edad43c2c0a.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 Marketing end Sample Exclude flag Status 72205-066-91 72205006691 100 TABLET in 1 BOTTLE (72205-066-91) 100 tablet 2022-11-22 0000-00-00 No No Current 72205-066-99 72205006699 1000 TABLET in 1 BOTTLE (72205-066-99) 1000 tablet 2022-11-22 0000-00-00 No No Current