Home NDC 51079-734 Haloperidol
Product NDC 51079-734
11-digit product format 510790734
Labeler code 51079
Product ID 51079-734_3dd4fea4-d455-5a4d-e063-6394a90ab14c
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name haloperidol
Dosage form TABLET
Route ORAL
Labeler Mylan Institutional Inc.
Application ANDA070278
Marketing category ANDA
Marketing start 2004-02-01
Substance HALOPERIDOL
Active strength 1 mg/1
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 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 A070278-001 HALOPERIDOL HALOPERIDOL 2MG TABLET / ORAL AB 1986-06-10 A070278-002 HALOPERIDOL HALOPERIDOL 10MG TABLET / ORAL AB 2009-07-16 A070278-003 HALOPERIDOL HALOPERIDOL 20MG TABLET / ORAL 2009-07-16 A070278-004 HALOPERIDOL HALOPERIDOL 1MG TABLET / ORAL AB 1986-06-10 A070278-005 HALOPERIDOL HALOPERIDOL 5MG TABLET / ORAL AB 1986-06-10 A070278-006 HALOPERIDOL HALOPERIDOL 0.5MG TABLET / ORAL AB 1986-06-10
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 5 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 7 · 252 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 A070278-001 HALOPERIDOL 2MG TABLET / ORAL AB 1986-06-10 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A070278-002 HALOPERIDOL 10MG TABLET / ORAL AB 2009-07-16 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A070278-003 HALOPERIDOL 20MG TABLET / ORAL 2009-07-16 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A070278-004 HALOPERIDOL 1MG TABLET / ORAL AB 1986-06-10 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A070278-005 HALOPERIDOL 5MG TABLET / ORAL AB 1986-06-10 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A070278-006 HALOPERIDOL 0.5MG TABLET / ORAL AB 1986-06-10 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A070278-001 HALOPERIDOL 2MG TABLET / ORAL AB RS 1986-06-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A070278-002 HALOPERIDOL 10MG TABLET / ORAL AB 2009-07-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A070278-003 HALOPERIDOL 20MG TABLET / ORAL AB 2009-07-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A070278-004 HALOPERIDOL 1MG TABLET / ORAL AB 1986-06-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A070278-005 HALOPERIDOL 5MG TABLET / ORAL AB 1986-06-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A070278-006 HALOPERIDOL 0.5MG TABLET / ORAL AB 1986-06-10 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A070278-001 HALOPERIDOL 2MG TABLET / ORAL AB RS 1986-06-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A070278-002 HALOPERIDOL 10MG TABLET / ORAL AB 2009-07-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A070278-003 HALOPERIDOL 20MG TABLET / ORAL AB 2009-07-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A070278-004 HALOPERIDOL 1MG TABLET / ORAL AB 1986-06-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A070278-005 HALOPERIDOL 5MG TABLET / ORAL AB 1986-06-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A070278-006 HALOPERIDOL 0.5MG TABLET / ORAL AB 1986-06-10 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A070278-001 HALOPERIDOL 2MG TABLET / ORAL AB RS 1986-06-10 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A070278-002 HALOPERIDOL 10MG TABLET / ORAL AB 2009-07-16 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A070278-003 HALOPERIDOL 20MG TABLET / ORAL AB 2009-07-16 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A070278-004 HALOPERIDOL 1MG TABLET / ORAL AB 1986-06-10 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A070278-005 HALOPERIDOL 5MG TABLET / ORAL AB 1986-06-10 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A070278-006 HALOPERIDOL 0.5MG TABLET / ORAL AB 1986-06-10 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A070278-001 HALOPERIDOL 2MG TABLET / ORAL AB RS 1986-06-10 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A070278-002 HALOPERIDOL 10MG TABLET / ORAL AB 2009-07-16 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A070278-003 HALOPERIDOL 20MG TABLET / ORAL AB 2009-07-16 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A070278-004 HALOPERIDOL 1MG TABLET / ORAL AB 1986-06-10 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A070278-005 HALOPERIDOL 5MG TABLET / ORAL AB 1986-06-10 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A070278-006 HALOPERIDOL 0.5MG TABLET / ORAL AB 1986-06-10 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A070278-001 HALOPERIDOL 2MG TABLET / ORAL AB RS 1986-06-10 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A070278-002 HALOPERIDOL 10MG TABLET / ORAL AB 2009-07-16 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A070278-003 HALOPERIDOL 20MG TABLET / ORAL AB 2009-07-16 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A070278-004 HALOPERIDOL 1MG TABLET / ORAL AB 1986-06-10 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A070278-005 HALOPERIDOL 5MG TABLET / ORAL AB 1986-06-10 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A070278-006 HALOPERIDOL 0.5MG TABLET / ORAL AB 1986-06-10 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A070278-001 HALOPERIDOL 2MG TABLET / ORAL AB RS 1986-06-10 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A070278-002 HALOPERIDOL 10MG TABLET / ORAL AB 2009-07-16 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A070278-003 HALOPERIDOL 20MG TABLET / ORAL AB 2009-07-16 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A070278-004 HALOPERIDOL 1MG TABLET / ORAL AB 1986-06-10 03ed91905a0d…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 7 · 246 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 1 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 · 5 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 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 51079-734-01 Haloperidol 1 in 1 BLISTER PACK TABLET 1 18 51079-734-20 Haloperidol 100 in 1 CARTON TABLET 100 18
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 51079-734 HALOPERIDOL TABLET [MYLAN INSTITUTIONAL INC.] 16 Current NDC, Legacy NDC, 2 package rows 20211217_ad7d2f17-a4e8-4ebc-9baf-5983ac626782.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 · 4 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Haloperidol HALOPERIDOL Cardinal Health 107, LLC 8ca14b79-6671-4e44-aa34-6564a92aa197 2025-10-14 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 070278 application number: ANDA070278 Haloperidol HALOPERIDOL Mylan Institutional Inc. ad7d2f17-a4e8-4ebc-9baf-5983ac626782 2025-09-02 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 070278 application number: ANDA070278 ndc (product): 51079-734 Haloperidol HALOPERIDOL Coupler LLC 2ccc2e26-de98-af81-e063-6394a90a040b 2025-01-28 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 070278 application number: ANDA070278 Haloperidol HALOPERIDOL Mylan Pharmaceuticals Inc. c559b0b0-4087-d12a-e718-c18ccb6811e6 2025-01-15 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 070278 application number: ANDA070278
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 51079-734-01 51079073401 1 in 1 BLISTER PACK Historical 51079-734-20 51079073420 100 BLISTER PACK in 1 CARTON (51079-734-20) / 1 TABLET in 1 BLISTER PACK (51079-734-01) 100 blister pack 2004-02-01 0000-00-00 No No Current