Haloperidol

Product NDC
0904-7390
11-digit product format
009047390
Labeler code
0904
Product ID
0904-7390_5cdf5cc5-d403-44de-84bd-b94363e8bd60
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Haloperidol
Dosage form
TABLET
Route
ORAL
Labeler
Major Pharmaceuticals
Application
ANDA071173
Marketing category
ANDA
Marketing start
2023-07-18
Marketing end
2026-06-30
Substance
HALOPERIDOL
Active strength
1 mg/1
Pharmacologic classes
Typical Antipsychotic [EPC]
NDC exclude flag
No
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct0904-7390DDiscontinued by firm2026-08-11
excluded packagepackage0904-73900904-7390-61DDiscontinued by firm2026-08-11

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…

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
0904-7390-61Haloperidol100 in 1 CARTONTABLET1004
0904-7390-61Haloperidol1 in 1 BLISTER PACKTABLET14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-7390-61EA - Each0904-7390dfc1b0f9-1da2-4eda-9c4a-4b32c3e990be12023-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0904-7390HALOPERIDOL TABLET [MAJOR PHARMACEUTICALS]3Current NDC, 2 package rows20250321_f5bfb3b9-0c6d-4f04-8bfc-d063cd8bb8ed.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.051f3c99-7d16-4185-a857-c90440e1b1c52026-07-31Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071173
application number: ANDA071173
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.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
310670haloperidol 0.5 MG Oral TabletPSNf5bfb3b9-0c6d-4f04-8bfc-d063cd8bb8ed4
310671haloperidol 1 MG Oral TabletPSNf5bfb3b9-0c6d-4f04-8bfc-d063cd8bb8ed4
314034haloperidol 2 MG Oral TabletPSNf5bfb3b9-0c6d-4f04-8bfc-d063cd8bb8ed4
310670haloperidol 0.5 MG Oral TabletSCDf5bfb3b9-0c6d-4f04-8bfc-d063cd8bb8ed4
310671haloperidol 1 MG Oral TabletSCDf5bfb3b9-0c6d-4f04-8bfc-d063cd8bb8ed4
314034haloperidol 2 MG Oral TabletSCDf5bfb3b9-0c6d-4f04-8bfc-d063cd8bb8ed4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0904-7390-6100904739061100 BLISTER PACK in 1 CARTON (0904-7390-61) / 1 TABLET in 1 BLISTER PACK100 blister pack2023-07-182026-06-30NoNoHistorical