Haloperidol

Product NDC
10135-753
11-digit product format
101350753
Labeler code
10135
Product ID
10135-753_23e5e8d5-bddd-f9a9-e063-6394a90adb0c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Haloperidol
Dosage form
TABLET
Route
ORAL
Labeler
Marlex Pharmaceuticals, Inc.
Application
ANDA071173
Marketing category
ANDA
Marketing start
2022-08-01
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 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
e7a61604-741f-2d3b-e053-2995a90a62fcAvailable 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
10135-753-01Haloperidol100 in 1 BOTTLETABLET1002
10135-753-10Haloperidol1000 in 1 BOTTLETABLET10002

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
10135-753-01EA - Each10135-753c3f2087e-e362-4e1f-8747-81309335d1f912022-10-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10135-753HALOPERIDOL TABLET [MARLEX PHARMACEUTICALS, INC.]2Current NDC, Legacy NDC, 2 package rows20241009_e7a61604-741f-2d3b-e053-2995a90a62fc.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
ndc (product): 10135-753
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 TabletPSNe7a61604-741f-2d3b-e053-2995a90a62fc2
310671haloperidol 1 MG Oral TabletPSNe7a61604-741f-2d3b-e053-2995a90a62fc2
314035haloperidol 10 MG Oral TabletPSNe7a61604-741f-2d3b-e053-2995a90a62fc2
314034haloperidol 2 MG Oral TabletPSNe7a61604-741f-2d3b-e053-2995a90a62fc2
197754haloperidol 20 MG Oral TabletPSNe7a61604-741f-2d3b-e053-2995a90a62fc2
310672haloperidol 5 MG Oral TabletPSNe7a61604-741f-2d3b-e053-2995a90a62fc2
310670haloperidol 0.5 MG Oral TabletSCDe7a61604-741f-2d3b-e053-2995a90a62fc2
310671haloperidol 1 MG Oral TabletSCDe7a61604-741f-2d3b-e053-2995a90a62fc2
314035haloperidol 10 MG Oral TabletSCDe7a61604-741f-2d3b-e053-2995a90a62fc2
314034haloperidol 2 MG Oral TabletSCDe7a61604-741f-2d3b-e053-2995a90a62fc2
197754haloperidol 20 MG Oral TabletSCDe7a61604-741f-2d3b-e053-2995a90a62fc2
310672haloperidol 5 MG Oral TabletSCDe7a61604-741f-2d3b-e053-2995a90a62fc2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
10135-753-0110135075301100 TABLET in 1 BOTTLE (10135-753-01) 100 tablet2022-08-010000-00-00NoNoCurrent
10135-753-10101350753101000 TABLET in 1 BOTTLE (10135-753-10) 1000 tablet2022-08-010000-00-00NoNoCurrent