Haloperidol

Product NDC
65841-626
11-digit product format
658410626
Labeler code
65841
Product ID
65841-626_2ff366f9-878f-4fcb-b2d4-00fb6e31ecbf
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Haloperidol
Dosage form
TABLET
Route
ORAL
Labeler
Zydus Lifesciences Limited
Application
ANDA077580
Marketing category
ANDA
Marketing start
2008-01-03
Substance
HALOPERIDOL
Active strength
5 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 1.

Orange Book products#

Current product rows page 1 of 1 · 6 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A077580-001HALOPERIDOLHALOPERIDOL0.5MGTABLET / ORALAB2023-01-17
A077580-002HALOPERIDOLHALOPERIDOL1MGTABLET / ORALAB2023-01-17
A077580-003HALOPERIDOLHALOPERIDOL5MGTABLET / ORALAB2007-11-29
A077580-004HALOPERIDOLHALOPERIDOL10MGTABLET / ORALAB2007-11-29
A077580-005HALOPERIDOLHALOPERIDOL20MGTABLET / ORALAB2007-11-29
A077580-006HALOPERIDOLHALOPERIDOL2MGTABLET / ORALAB2023-01-17

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 6 matching rows.

Application-product, TE code table
Application-productTE code
A077580-001AB
A077580-002AB
A077580-003AB
A077580-004AB
A077580-005AB
A077580-006AB

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 5 · 192 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A077580-001HALOPERIDOL0.5MGTABLET / ORALAB2023-01-17011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077580-002HALOPERIDOL1MGTABLET / ORALAB2023-01-17011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077580-003HALOPERIDOL5MGTABLET / ORALAB2007-11-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077580-004HALOPERIDOL10MGTABLET / ORALAB2007-11-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077580-005HALOPERIDOL20MGTABLET / ORALAB2007-11-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077580-006HALOPERIDOL2MGTABLET / ORALAB2023-01-17011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077580-001HALOPERIDOL0.5MGTABLET / ORALAB2023-01-1731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077580-002HALOPERIDOL1MGTABLET / ORALAB2023-01-1731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077580-003HALOPERIDOL5MGTABLET / ORALAB2007-11-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077580-004HALOPERIDOL10MGTABLET / ORALAB2007-11-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077580-005HALOPERIDOL20MGTABLET / ORALAB2007-11-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077580-006HALOPERIDOL2MGTABLET / ORALAB2023-01-1731067a03dcf5…
2025-08-23 18:47 UTC2025-08A077580-001HALOPERIDOL0.5MGTABLET / ORALAB2023-01-176a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077580-002HALOPERIDOL1MGTABLET / ORALAB2023-01-176a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077580-003HALOPERIDOL5MGTABLET / ORALAB2007-11-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077580-004HALOPERIDOL10MGTABLET / ORALAB2007-11-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077580-005HALOPERIDOL20MGTABLET / ORALAB2007-11-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077580-006HALOPERIDOL2MGTABLET / ORALAB2023-01-176a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077580-001HALOPERIDOL0.5MGTABLET / ORALAB2023-01-17fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077580-002HALOPERIDOL1MGTABLET / ORALAB2023-01-17fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077580-003HALOPERIDOL5MGTABLET / ORALAB2007-11-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077580-004HALOPERIDOL10MGTABLET / ORALAB2007-11-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077580-005HALOPERIDOL20MGTABLET / ORALAB2007-11-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077580-006HALOPERIDOL2MGTABLET / ORALAB2023-01-17fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077580-001HALOPERIDOL0.5MGTABLET / ORALAB2023-01-17b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077580-002HALOPERIDOL1MGTABLET / ORALAB2023-01-17b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077580-003HALOPERIDOL5MGTABLET / ORALAB2007-11-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077580-004HALOPERIDOL10MGTABLET / ORALAB2007-11-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077580-005HALOPERIDOL20MGTABLET / ORALAB2007-11-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077580-006HALOPERIDOL2MGTABLET / ORALAB2023-01-17b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077580-001HALOPERIDOL0.5MGTABLET / ORALAB2023-01-1703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077580-002HALOPERIDOL1MGTABLET / ORALAB2023-01-1703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077580-003HALOPERIDOL5MGTABLET / ORALAB2007-11-2903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077580-004HALOPERIDOL10MGTABLET / ORALAB2007-11-2903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077580-005HALOPERIDOL20MGTABLET / ORALAB2007-11-2903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077580-006HALOPERIDOL2MGTABLET / ORALAB2023-01-1703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077580-001HALOPERIDOL0.5MGTABLET / ORALAB2023-01-172680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077580-002HALOPERIDOL1MGTABLET / ORALAB2023-01-172680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077580-003HALOPERIDOL5MGTABLET / ORALAB2007-11-292680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077580-004HALOPERIDOL10MGTABLET / ORALAB2007-11-292680178bc6a6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 192 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A077580-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077580-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077580-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077580-004AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077580-005AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077580-006AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077580-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077580-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077580-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077580-004AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077580-005AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077580-006AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A077580-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077580-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077580-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077580-004AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077580-005AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077580-006AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077580-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077580-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077580-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077580-004AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077580-005AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077580-006AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077580-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077580-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077580-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077580-004AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077580-005AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077580-006AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077580-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077580-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077580-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077580-004AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077580-005AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077580-006AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077580-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077580-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077580-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077580-004AB12680178bc6a6…

Additional Listing Data#

Finished product
Yes
Brand name base
Haloperidol
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HALOPERIDOL5 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
J6292F8L3DInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 6 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
197754Internal RxNorm lookup
310670Internal RxNorm lookup
310671Internal RxNorm lookup
310672Internal RxNorm lookup
314034Internal RxNorm lookup
314035Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
509d0eb2-b930-4836-9669-dbebf0ac4076Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d599bae4-cb25-0798-7468-31aa188fb750Product name720260304
6aae29ef-bf3c-3ebb-3bf1-10ee5424a22eProduct name220250114
af58e43a-5792-c2c1-8e57-a2454df1f2c0Product name320240202
ce329990-eb12-45a5-87d5-ce5ef054ca71Product name220190930

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65841-626-01Haloperidol100 in 1 BOTTLETABLET1008
65841-626-10Haloperidol1000 in 1 BOTTLETABLET10008

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
HALOPERIDOLACTIVE INGREDIENTJ6292F8L3DHALOPERIDOL TABLET [CADILA HEALTHCARE LIMITED]1
HALOPERIDOLACTIVE MOIETYJ6292F8L3DHALOPERIDOL TABLET [CADILA HEALTHCARE LIMITED]1
CALCIUM STEARATEINACTIVE INGREDIENT776XM7047LHALOPERIDOL TABLET [CADILA HEALTHCARE LIMITED]1
D&C RED NO. 27INACTIVE INGREDIENT2LRS185U6KHALOPERIDOL TABLET [CADILA HEALTHCARE LIMITED]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GHALOPERIDOL TABLET [CADILA HEALTHCARE LIMITED]1
DIBASIC CALCIUM PHOSPHATE DIHYDRATEINACTIVE INGREDIENTO7TSZ97GEPHALOPERIDOL TABLET [CADILA HEALTHCARE LIMITED]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDHALOPERIDOL TABLET [CADILA HEALTHCARE LIMITED]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8HALOPERIDOL TABLET [CADILA HEALTHCARE LIMITED]1
POVIDONE K30INACTIVE INGREDIENTU725QWY32XHALOPERIDOL TABLET [CADILA HEALTHCARE LIMITED]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2HALOPERIDOL TABLET [CADILA HEALTHCARE LIMITED]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJHALOPERIDOL TABLET [CADILA HEALTHCARE LIMITED]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65841-626HALOPERIDOL TABLET [ZYDUS LIFESCIENCES LIMITED]8Current NDC, Legacy NDC, 2 package rows20241201_509d0eb2-b930-4836-9669-dbebf0ac4076.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 · 14 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
HaloperidolHALOPERIDOLREMEDYREPACK INC.746f3ab9-9e6e-4ce8-9384-0c7a57de80072026-07-08Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077580
application number: ANDA077580
HaloperidolHALOPERIDOLUnit Dose Solutions, Inc.54ee5fa9-e346-a1d0-e063-6294a90aef832026-06-23Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077580
application number: ANDA077580
HaloperidolHALOPERIDOLSafecor Health, LLC9be08519-b3b5-4b9d-ae4c-bb7e68f19ede2026-06-11Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077580
application number: ANDA077580
HaloperidolHALOPERIDOLCardinal Health 107, LLCeaabdc53-366f-4dc2-b9c7-0d70f1bbb6f92026-05-15Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077580
application number: ANDA077580
HaloperidolHALOPERIDOLCoupler LLC26aa869a-25e8-0dd5-e063-6394a90a0aba2026-04-29Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077580
application number: ANDA077580
HaloperidolHALOPERIDOLCoupler LLC509e5424-1323-c841-e063-6294a90a27142026-04-29Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077580
application number: ANDA077580
HaloperidolHALOPERIDOLMajor Pharmaceuticalse07f02d4-2768-4978-97ee-23ac52d0b8462026-03-19Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077580
application number: ANDA077580
HaloperidolHALOPERIDOLREMEDYREPACK INC.1e396020-899d-4f51-b71a-4982c503ca4f2026-01-19Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077580
application number: ANDA077580
HaloperidolHALOPERIDOLREMEDYREPACK INC.58fa9328-b1c7-407c-b215-9887db90cb942026-01-19Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077580
application number: ANDA077580
HaloperidolHALOPERIDOLAmerican Health Packaging0ac0cc44-3924-447d-9051-f84c443123802025-06-16Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077580
application number: ANDA077580
HaloperidolHALOPERIDOLAmerican Health Packagingd62617da-c8ad-45da-8915-c59edc5558a52025-06-16Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077580
application number: ANDA077580
HaloperidolHALOPERIDOLCoupler LLC315899f3-d510-10b0-e063-6294a90a2f3e2025-03-27Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077580
application number: ANDA077580
HaloperidolHALOPERIDOLZydus Lifesciences Limited509d0eb2-b930-4836-9669-dbebf0ac40762024-11-30Exact identifier
application applno (ANDA): 077580
application number: ANDA077580
ndc (product): 65841-626
HaloperidolHALOPERIDOLZydus Pharmaceuticals USA Inc.54502f78-7244-454a-9171-4e73127f14562024-11-14Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077580
application number: ANDA077580

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310670haloperidol 0.5 MG Oral TabletPSN509d0eb2-b930-4836-9669-dbebf0ac40768
310671haloperidol 1 MG Oral TabletPSN509d0eb2-b930-4836-9669-dbebf0ac40768
314035haloperidol 10 MG Oral TabletPSN509d0eb2-b930-4836-9669-dbebf0ac40768
314034haloperidol 2 MG Oral TabletPSN509d0eb2-b930-4836-9669-dbebf0ac40768
197754haloperidol 20 MG Oral TabletPSN509d0eb2-b930-4836-9669-dbebf0ac40768
310672haloperidol 5 MG Oral TabletPSN509d0eb2-b930-4836-9669-dbebf0ac40768
310670haloperidol 0.5 MG Oral TabletSCD509d0eb2-b930-4836-9669-dbebf0ac40768
310671haloperidol 1 MG Oral TabletSCD509d0eb2-b930-4836-9669-dbebf0ac40768
314035haloperidol 10 MG Oral TabletSCD509d0eb2-b930-4836-9669-dbebf0ac40768
314034haloperidol 2 MG Oral TabletSCD509d0eb2-b930-4836-9669-dbebf0ac40768
197754haloperidol 20 MG Oral TabletSCD509d0eb2-b930-4836-9669-dbebf0ac40768
310672haloperidol 5 MG Oral TabletSCD509d0eb2-b930-4836-9669-dbebf0ac40768

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65841-626-0165841062601100 TABLET in 1 BOTTLE (65841-626-01) 100 tablet2008-01-030000-00-00NoNoCurrent
65841-626-10658410626101000 TABLET in 1 BOTTLE (65841-626-10) 1000 tablet2008-01-030000-00-00NoNoCurrent