Haloperidol

Product NDC
69292-582
11-digit product format
692920582
Labeler code
69292
Product ID
69292-582_8c9cdd3d-9751-404a-9ceb-276e8dfa6391
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Haloperidol
Dosage form
TABLET
Route
ORAL
Labeler
Amici Pharmaceuticals, LLC
Application
ANDA071173
Marketing category
ANDA
Marketing start
2022-04-18
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 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
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HALOPERIDOL1 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
9a9e20dd-646a-4fe9-a345-1b5bda8e7775Available 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
69292-582-01Haloperidol100 in 1 BOTTLETABLET1002

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69292-582-01EA - Each69292-5824e3c7550-4dbf-48f5-8249-1806a1028ade12022-05-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69292-582HALOPERIDOL TABLET [AMICI PHARMACEUTICALS, LLC]2Current NDC, Legacy NDC, 1 package rows20220503_9a9e20dd-646a-4fe9-a345-1b5bda8e7775.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
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
310670haloperidol 0.5 MG Oral TabletPSN9a9e20dd-646a-4fe9-a345-1b5bda8e77752
310671haloperidol 1 MG Oral TabletPSN9a9e20dd-646a-4fe9-a345-1b5bda8e77752
314035haloperidol 10 MG Oral TabletPSN9a9e20dd-646a-4fe9-a345-1b5bda8e77752
314034haloperidol 2 MG Oral TabletPSN9a9e20dd-646a-4fe9-a345-1b5bda8e77752
197754haloperidol 20 MG Oral TabletPSN9a9e20dd-646a-4fe9-a345-1b5bda8e77752
310672haloperidol 5 MG Oral TabletPSN9a9e20dd-646a-4fe9-a345-1b5bda8e77752
310670haloperidol 0.5 MG Oral TabletSCD9a9e20dd-646a-4fe9-a345-1b5bda8e77752
310671haloperidol 1 MG Oral TabletSCD9a9e20dd-646a-4fe9-a345-1b5bda8e77752
314035haloperidol 10 MG Oral TabletSCD9a9e20dd-646a-4fe9-a345-1b5bda8e77752
314034haloperidol 2 MG Oral TabletSCD9a9e20dd-646a-4fe9-a345-1b5bda8e77752
197754haloperidol 20 MG Oral TabletSCD9a9e20dd-646a-4fe9-a345-1b5bda8e77752
310672haloperidol 5 MG Oral TabletSCD9a9e20dd-646a-4fe9-a345-1b5bda8e77752

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69292-582-0169292058201100 TABLET in 1 BOTTLE (69292-582-01) 100 tablet2022-04-180000-00-00NoNoCurrent