Haloperidol

Product NDC
0615-8355
11-digit product format
006158355
Labeler code
0615
Product ID
0615-8355_b2861983-5663-4c40-b300-4a5248c6c892
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Haloperidol
Dosage form
TABLET
Route
ORAL
Labeler
NCS HealthCare of KY, LLC dba Vangard Labs
Application
ANDA211061
Marketing category
ANDA
Marketing start
2020-01-09
Marketing end
2026-05-31
Substance
HALOPERIDOL
Active strength
5 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 productproduct0615-8355DDiscontinued by firm2026-08-11
excluded packagepackage0615-83550615-8355-39DDiscontinued 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
A211061-001HALOPERIDOLHALOPERIDOL0.5MGTABLET / ORALAB2020-01-08
A211061-002HALOPERIDOLHALOPERIDOL1MGTABLET / ORALAB2020-01-08
A211061-003HALOPERIDOLHALOPERIDOL2MGTABLET / ORALAB2020-01-08
A211061-004HALOPERIDOLHALOPERIDOL5MGTABLET / ORALAB2020-01-08
A211061-005HALOPERIDOLHALOPERIDOL10MGTABLET / ORALAB2020-01-08
A211061-006HALOPERIDOLHALOPERIDOL20MGTABLET / ORALAB2020-01-08

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A211061-001AB
A211061-002AB
A211061-003AB
A211061-004AB
A211061-005AB
A211061-006AB

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 6 · 222 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A211061-001HALOPERIDOL0.5MGTABLET / ORALAB2020-01-08011fe1cb6892…
2026-02-19 14:30 UTC2026-02A211061-002HALOPERIDOL1MGTABLET / ORALAB2020-01-08011fe1cb6892…
2026-02-19 14:30 UTC2026-02A211061-003HALOPERIDOL2MGTABLET / ORALAB2020-01-08011fe1cb6892…
2026-02-19 14:30 UTC2026-02A211061-004HALOPERIDOL5MGTABLET / ORALAB2020-01-08011fe1cb6892…
2026-02-19 14:30 UTC2026-02A211061-005HALOPERIDOL10MGTABLET / ORALAB2020-01-08011fe1cb6892…
2026-02-19 14:30 UTC2026-02A211061-006HALOPERIDOL20MGTABLET / ORALAB2020-01-08011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211061-001HALOPERIDOL0.5MGTABLET / ORALAB2020-01-0831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211061-002HALOPERIDOL1MGTABLET / ORALAB2020-01-0831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211061-003HALOPERIDOL2MGTABLET / ORALAB2020-01-0831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211061-004HALOPERIDOL5MGTABLET / ORALAB2020-01-0831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211061-005HALOPERIDOL10MGTABLET / ORALAB2020-01-0831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211061-006HALOPERIDOL20MGTABLET / ORALAB2020-01-0831067a03dcf5…
2025-08-23 18:47 UTC2025-08A211061-001HALOPERIDOL0.5MGTABLET / ORALAB2020-01-086a471c1ec25d…
2025-08-23 18:47 UTC2025-08A211061-002HALOPERIDOL1MGTABLET / ORALAB2020-01-086a471c1ec25d…
2025-08-23 18:47 UTC2025-08A211061-003HALOPERIDOL2MGTABLET / ORALAB2020-01-086a471c1ec25d…
2025-08-23 18:47 UTC2025-08A211061-004HALOPERIDOL5MGTABLET / ORALAB2020-01-086a471c1ec25d…
2025-08-23 18:47 UTC2025-08A211061-005HALOPERIDOL10MGTABLET / ORALAB2020-01-086a471c1ec25d…
2025-08-23 18:47 UTC2025-08A211061-006HALOPERIDOL20MGTABLET / ORALAB2020-01-086a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211061-001HALOPERIDOL0.5MGTABLET / ORALAB2020-01-08fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211061-002HALOPERIDOL1MGTABLET / ORALAB2020-01-08fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211061-003HALOPERIDOL2MGTABLET / ORALAB2020-01-08fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211061-004HALOPERIDOL5MGTABLET / ORALAB2020-01-08fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211061-005HALOPERIDOL10MGTABLET / ORALAB2020-01-08fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211061-006HALOPERIDOL20MGTABLET / ORALAB2020-01-08fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211061-001HALOPERIDOL0.5MGTABLET / ORALAB2020-01-08b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211061-002HALOPERIDOL1MGTABLET / ORALAB2020-01-08b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211061-003HALOPERIDOL2MGTABLET / ORALAB2020-01-08b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211061-004HALOPERIDOL5MGTABLET / ORALAB2020-01-08b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211061-005HALOPERIDOL10MGTABLET / ORALAB2020-01-08b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211061-006HALOPERIDOL20MGTABLET / ORALAB2020-01-08b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211061-001HALOPERIDOL0.5MGTABLET / ORALAB2020-01-0803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211061-002HALOPERIDOL1MGTABLET / ORALAB2020-01-0803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211061-003HALOPERIDOL2MGTABLET / ORALAB2020-01-0803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211061-004HALOPERIDOL5MGTABLET / ORALAB2020-01-0803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211061-005HALOPERIDOL10MGTABLET / ORALAB2020-01-0803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211061-006HALOPERIDOL20MGTABLET / ORALAB2020-01-0803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211061-001HALOPERIDOL0.5MGTABLET / ORALAB2020-01-082680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211061-002HALOPERIDOL1MGTABLET / ORALAB2020-01-082680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211061-003HALOPERIDOL2MGTABLET / ORALAB2020-01-082680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211061-004HALOPERIDOL5MGTABLET / ORALAB2020-01-082680178bc6a6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 6 · 222 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A211061-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A211061-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A211061-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A211061-004AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A211061-005AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A211061-006AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211061-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211061-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211061-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211061-004AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211061-005AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211061-006AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A211061-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A211061-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A211061-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A211061-004AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A211061-005AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A211061-006AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211061-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211061-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211061-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211061-004AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211061-005AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211061-006AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211061-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211061-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211061-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211061-004AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211061-005AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211061-006AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211061-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211061-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211061-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211061-004AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211061-005AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211061-006AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211061-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211061-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211061-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211061-004AB12680178bc6a6…

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
0615-8355-39Haloperidol30 in 1 BLISTER PACKTABLET303

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0615-8355HALOPERIDOL TABLET [NCS HEALTHCARE OF KY, LLC DBA VANGARD LABS]2Current NDC, Legacy NDC, 1 package rows20241020_e7dcb764-d58d-4476-b981-3bd54f0d896e.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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
HaloperidolHALOPERIDOLUpsher-Smith Laboratories, LLCafb3ac3e-7459-42d3-b5ca-e0d6d27ced732026-08-05Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211061
application number: ANDA211061

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0615-8355-390061583553930 TABLET in 1 BLISTER PACK (0615-8355-39) 30 tablet2020-10-202026-05-31NoNoCurrent