Haloperidol

Product NDC
70518-3021
11-digit product format
705183021
Labeler code
70518
Product ID
70518-3021_4af336d0-4aac-a0c8-e063-6394a90a4f51
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Haloperidol
Dosage form
TABLET
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA071173
Marketing category
ANDA
Marketing start
2021-02-10
Substance
HALOPERIDOL
Active strength
20 mg/1
Pharmacologic classes
Typical Antipsychotic [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage70518-302170518-3021-1DDiscontinued by firm2026-08-03

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 1 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage70518-302170518-3021-1DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…

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
A071173-001HALOPERIDOLHALOPERIDOL10MGTABLET / ORALAB1988-01-07
A071173-002HALOPERIDOLHALOPERIDOL0.5MGTABLET / ORALAB1987-01-02
A071173-003HALOPERIDOLHALOPERIDOL1MGTABLET / ORALAB1987-01-02
A071173-004HALOPERIDOLHALOPERIDOL2MGTABLET / ORALAB1987-01-02
A071173-005HALOPERIDOLHALOPERIDOL5MGTABLET / ORALAB1988-01-07
A071173-006HALOPERIDOLHALOPERIDOL20MGTABLET / ORALAB1988-01-07

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A071173-001AB
A071173-002AB
A071173-003AB
A071173-004AB
A071173-005AB
A071173-006AB

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 7 · 246 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A071173-001HALOPERIDOL10MGTABLET / ORALAB1988-01-07011fe1cb6892…
2026-02-19 14:30 UTC2026-02A071173-002HALOPERIDOL0.5MGTABLET / ORALAB1987-01-02011fe1cb6892…
2026-02-19 14:30 UTC2026-02A071173-003HALOPERIDOL1MGTABLET / ORALAB1987-01-02011fe1cb6892…
2026-02-19 14:30 UTC2026-02A071173-004HALOPERIDOL2MGTABLET / ORALAB1987-01-02011fe1cb6892…
2026-02-19 14:30 UTC2026-02A071173-005HALOPERIDOL5MGTABLET / ORALAB1988-01-07011fe1cb6892…
2026-02-19 14:30 UTC2026-02A071173-006HALOPERIDOL20MGTABLET / ORALAB1988-01-07011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A071173-001HALOPERIDOL10MGTABLET / ORALAB1988-01-0731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A071173-002HALOPERIDOL0.5MGTABLET / ORALAB1987-01-0231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A071173-003HALOPERIDOL1MGTABLET / ORALAB1987-01-0231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A071173-004HALOPERIDOL2MGTABLET / ORALAB1987-01-0231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A071173-005HALOPERIDOL5MGTABLET / ORALAB1988-01-0731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A071173-006HALOPERIDOL20MGTABLET / ORALAB1988-01-0731067a03dcf5…
2025-08-23 18:47 UTC2025-08A071173-001HALOPERIDOL10MGTABLET / ORALAB1988-01-076a471c1ec25d…
2025-08-23 18:47 UTC2025-08A071173-002HALOPERIDOL0.5MGTABLET / ORALAB1987-01-026a471c1ec25d…
2025-08-23 18:47 UTC2025-08A071173-003HALOPERIDOL1MGTABLET / ORALAB1987-01-026a471c1ec25d…
2025-08-23 18:47 UTC2025-08A071173-004HALOPERIDOL2MGTABLET / ORALAB1987-01-026a471c1ec25d…
2025-08-23 18:47 UTC2025-08A071173-005HALOPERIDOL5MGTABLET / ORALAB1988-01-076a471c1ec25d…
2025-08-23 18:47 UTC2025-08A071173-006HALOPERIDOL20MGTABLET / ORALAB1988-01-076a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A071173-001HALOPERIDOL10MGTABLET / ORALAB1988-01-07fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A071173-002HALOPERIDOL0.5MGTABLET / ORALAB1987-01-02fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A071173-003HALOPERIDOL1MGTABLET / ORALAB1987-01-02fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A071173-004HALOPERIDOL2MGTABLET / ORALAB1987-01-02fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A071173-005HALOPERIDOL5MGTABLET / ORALAB1988-01-07fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A071173-006HALOPERIDOL20MGTABLET / ORALAB1988-01-07fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A071173-001HALOPERIDOL10MGTABLET / ORALAB1988-01-07b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A071173-002HALOPERIDOL0.5MGTABLET / ORALAB1987-01-02b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A071173-003HALOPERIDOL1MGTABLET / ORALAB1987-01-02b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A071173-004HALOPERIDOL2MGTABLET / ORALAB1987-01-02b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A071173-005HALOPERIDOL5MGTABLET / ORALAB1988-01-07b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A071173-006HALOPERIDOL20MGTABLET / ORALAB1988-01-07b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A071173-001HALOPERIDOL10MGTABLET / ORALAB1988-01-0703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A071173-002HALOPERIDOL0.5MGTABLET / ORALAB1987-01-0203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A071173-003HALOPERIDOL1MGTABLET / ORALAB1987-01-0203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A071173-004HALOPERIDOL2MGTABLET / ORALAB1987-01-0203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A071173-005HALOPERIDOL5MGTABLET / ORALAB1988-01-0703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A071173-006HALOPERIDOL20MGTABLET / ORALAB1988-01-0703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A071173-001HALOPERIDOL10MGTABLET / ORALAB1988-01-072680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A071173-002HALOPERIDOL0.5MGTABLET / ORALAB1987-01-022680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A071173-003HALOPERIDOL1MGTABLET / ORALAB1987-01-022680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A071173-004HALOPERIDOL2MGTABLET / ORALAB1987-01-022680178bc6a6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 6 · 234 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A071173-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A071173-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A071173-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A071173-004AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A071173-005AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A071173-006AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A071173-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A071173-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A071173-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A071173-004AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A071173-005AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A071173-006AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A071173-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A071173-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A071173-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A071173-004AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A071173-005AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A071173-006AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A071173-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A071173-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A071173-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A071173-004AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A071173-005AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A071173-006AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A071173-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A071173-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A071173-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A071173-004AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A071173-005AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A071173-006AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A071173-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A071173-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A071173-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A071173-004AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A071173-005AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A071173-006AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A071173-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A071173-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A071173-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A071173-004AB12680178bc6a6…

Additional Listing Data#

Finished product
Yes
Brand name base
Haloperidol
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HALOPERIDOL20 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 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
197754Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
051f3c99-7d16-4185-a857-c90440e1b1c5Available 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

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
EffectiveRelated label
2023-03-14Haloperidol Tablets, USP
2023-03-14Haloperidol Tablets, USP
2023-01-30Haloperidol Tablets, USP
2023-01-30Haloperidol Tablets, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70518-3021-0Haloperidol30 in 1 BLISTER PACKTABLET308
70518-3021-1Haloperidol100 in 1 BOXTABLET1008
70518-3021-2Haloperidol1 in 1 POUCHTABLET18

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-3021HALOPERIDOL TABLET [REMEDYREPACK INC.]5Current NDC, Legacy NDC, 3 package rows20250409_051f3c99-7d16-4185-a857-c90440e1b1c5.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 2 · 30 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
HaloperidolHALOPERIDOLREMEDYREPACK INC.861c7b75-572c-48c2-adf9-1ca3fc3db19b2026-04-27Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071173
application number: ANDA071173
HaloperidolHALOPERIDOLREMEDYREPACK INC.a3afd19a-c340-4fad-8ddd-d712425153452026-04-13Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071173
application number: ANDA071173
HaloperidolHALOPERIDOLREMEDYREPACK INC.22598f07-501b-471a-b512-449d95e2301c2026-04-13Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071173
application number: ANDA071173
HaloperidolHALOPERIDOLREMEDYREPACK INC.051f3c99-7d16-4185-a857-c90440e1b1c52026-02-16Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071173
application number: ANDA071173
ndc (product): 70518-3021
HaloperidolHALOPERIDOLREMEDYREPACK INC.eb69959d-5967-41ac-a222-ff4416869dfc2026-02-10Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071173
application number: ANDA071173
HaloperidolHALOPERIDOLREMEDYREPACK INC.b5a6c54c-fb70-4132-90ae-7d75b5e9c9de2026-02-10Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071173
application number: ANDA071173
HaloperidolHALOPERIDOLInnogenix, Inc.2c26af24-5ed3-4eb7-8d29-d6a019320a702026-01-06Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071173
application number: ANDA071173
HaloperidolHALOPERIDOLBryant Ranch Prepack966db55f-3f12-4653-9668-1beff85df0ab2025-10-29Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071173
application number: ANDA071173
HaloperidolHALOPERIDOLBryant Ranch Prepack5f4d945e-97f0-4afc-88d6-9b55ec2386862025-10-29Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071173
application number: ANDA071173
HaloperidolHALOPERIDOLBryant Ranch Prepack9353117e-bd01-441a-b35f-fd1352c5df8c2025-10-29Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071173
application number: ANDA071173
HaloperidolHALOPERIDOLBryant Ranch Prepack457b8b71-8acf-47f1-93e5-1d353e53af102025-10-29Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071173
application number: ANDA071173
HaloperidolHALOPERIDOLBryant Ranch Prepack2cffe2ad-3dad-479e-a91a-b41c3dd05ce12025-10-28Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071173
application number: ANDA071173
HaloperidolHALOPERIDOLCoupler LLC38f59751-4741-f588-e063-6294a90a65282025-07-02Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071173
application number: ANDA071173
HaloperidolHALOPERIDOLMethod Pharmaceuticals, LLC87f8773b-bf89-4f7e-bff4-8cad117d57762025-06-29Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071173
application number: ANDA071173
HaloperidolHALOPERIDOLBryant Ranch Prepack490efba9-70f1-46b8-9d62-2f96163e25df2025-06-26Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071173
application number: ANDA071173
HaloperidolHALOPERIDOLBryant Ranch Prepacke8977803-08a2-4ad0-87d5-63d81c98a5362024-12-27Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071173
application number: ANDA071173
HaloperidolHALOPERIDOLMarlex Pharmaceuticals, Inc.e7a61604-741f-2d3b-e053-2995a90a62fc2024-10-07Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071173
application number: ANDA071173
HaloperidolHALOPERIDOLBryant Ranch Prepackd9d0e530-02cd-4631-b3c8-cf6de521fd5b2024-10-04Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071173
application number: ANDA071173
HaloperidolHALOPERIDOLBryant Ranch Prepackdf340d75-7387-4084-9d76-167283ee74622024-08-12Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071173
application number: ANDA071173
HaloperidolHALOPERIDOLBryant Ranch Prepackd896823a-fb08-4777-a1f1-cef85fc8d96c2024-04-04Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071173
application number: ANDA071173

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197754haloperidol 20 MG Oral TabletPSN051f3c99-7d16-4185-a857-c90440e1b1c58
197754haloperidol 20 MG Oral TabletSCD051f3c99-7d16-4185-a857-c90440e1b1c58

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-3021-07051830210030 TABLET in 1 BLISTER PACK (70518-3021-0) 30 tablet2021-02-100000-00-00NoNoCurrent
70518-3021-170518302101100 in 1 BOXHistorical
70518-3021-2705183021021 in 1 POUCHHistorical