FDA.reportPublic FDA data

HALOPERIDOL DECANOATE

Product NDC
70069-867
11-digit product format
700690867
Labeler code
70069
Product ID
70069-867_75154f5d-21e4-4278-85f9-78a4a4e85741
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
HALOPERIDOL DECANOATE
Dosage form
INJECTION
Route
INTRAMUSCULAR
Labeler
Somerset Therapeutics, LLC
Application
ANDA219168
Marketing category
ANDA
Marketing start
2025-09-29
Substance
HALOPERIDOL DECANOATE
Active strength
100 mg/mL
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 42.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A219168-001HALOPERIDOL DECANOATEHALOPERIDOL DECANOATEEQ 50MG BASE/MLINJECTABLE / INJECTIONAO2025-05-13
A219168-002HALOPERIDOL DECANOATEHALOPERIDOL DECANOATEEQ 100MG BASE/MLINJECTABLE / INJECTIONAO2025-05-13

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A219168-001AO
A219168-002AO

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A219168-001HALOPERIDOL DECANOATEEQ 50MG BASE/MLINJECTABLE / INJECTIONAO2025-05-13caaa826d4ba7…
2026-08-18 06:07:402026-07A219168-002HALOPERIDOL DECANOATEEQ 100MG BASE/MLINJECTABLE / INJECTIONAO2025-05-13caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A219168-001HALOPERIDOL DECANOATEEQ 50MG BASE/MLINJECTABLE / INJECTIONAO2025-05-13011fe1cb6892…
2026-02-19 14:30 UTC2026-02A219168-002HALOPERIDOL DECANOATEEQ 100MG BASE/MLINJECTABLE / INJECTIONAO2025-05-13011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A219168-001HALOPERIDOL DECANOATEEQ 50MG BASE/MLINJECTABLE / INJECTIONAO2025-05-1331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A219168-002HALOPERIDOL DECANOATEEQ 100MG BASE/MLINJECTABLE / INJECTIONAO2025-05-1331067a03dcf5…
2025-08-23 18:47 UTC2025-08A219168-001HALOPERIDOL DECANOATEEQ 50MG BASE/MLINJECTABLE / INJECTIONAO2025-05-136a471c1ec25d…
2025-08-23 18:47 UTC2025-08A219168-002HALOPERIDOL DECANOATEEQ 100MG BASE/MLINJECTABLE / INJECTIONAO2025-05-136a471c1ec25d…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A219168-001HALOPERIDOL DECANOATEEQ 50MG BASE/MLINJECTABLE / INJECTIONAO2025-05-13a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A219168-002HALOPERIDOL DECANOATEEQ 100MG BASE/MLINJECTABLE / INJECTIONAO2025-05-13a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A219168-001AO1caaa826d4ba7…
2026-08-18 06:07:402026-07A219168-002AO1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A219168-001AO1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A219168-002AO1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A219168-001AO131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A219168-002AO131067a03dcf5…
2025-08-23 18:47 UTC2025-08A219168-001AO16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A219168-002AO16a471c1ec25d…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A219168-001AO1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A219168-002AO1a50c72e98297…

Additional Listing Data#

Finished product
Yes
Brand name base
HALOPERIDOL DECANOATE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HALOPERIDOL DECANOATE100 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
AC20PJ4101Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
859871Internal RxNorm lookup
1719803Internal RxNorm lookup
1719862Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
068fc913-779d-44c6-9585-3aa80e751beeAvailable 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
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70069-867-01HALOPERIDOL DECANOATE1 mL in 1 VIALINJECTION11
70069-867-05HALOPERIDOL DECANOATE5 in 1 CARTONINJECTION51
70069-867-10HALOPERIDOL DECANOATE10 in 1 CARTONINJECTION101

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70069-867-01ML - Milliliter70069-8678b6a0045-f92f-45fa-8672-0f02b1291c8512025-11-13
70069-867-05ML - Milliliter70069-867585a90c0-203d-47d0-afc9-5d5b8758db9012026-01-08
70069-867-10ML - Milliliter70069-86778fb27c7-ff8b-4520-baca-4e44f469cc7f12025-11-13

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 · 6 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Haloperidol DecanoateHALOPERIDOL DECANOATEArmas Pharmaceuticals Inc.80d51d2c-30e4-4eef-b184-0cebb30ca4292026-05-21Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 219168
application number: ANDA219168
Haloperidol DecanoateHALOPERIDOL DECANOATEArmas Pharmaceuticals Inc.9979e28f-2716-4788-8605-16f6edf158b52026-05-15Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 219168
application number: ANDA219168
Haloperidol DecanoateHALOPERIDOL DECANOATEREMEDYREPACK INC.15b82169-882b-40ef-bbda-5adc3e7eb9302026-03-10Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 219168
application number: ANDA219168
HALOPERIDOL DECANOATEHALOPERIDOL DECANOATESomerset Therapeutics, LLC068fc913-779d-44c6-9585-3aa80e751bee2025-09-30Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 219168
application number: ANDA219168
ndc (product): 70069-867
Haloperidol DecanoateHALOPERIDOL DECANOATECaplin Steriles Limited4f9af14a-38c4-4826-aca0-3501edb854e32025-05-26Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 219168
application number: ANDA219168
Haloperidol DecanoateHALOPERIDOL DECANOATEArmas Pharmaceuticals Inc.f9876b88-3caa-4c08-9a59-9b4a455e101d2025-05-26Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 219168
application number: ANDA219168

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1719803haloperidol decanoate 100 MG in 1 ML InjectionPSN068fc913-779d-44c6-9585-3aa80e751bee1
859871haloperidol decanoate 100 MG/ML Injectable SolutionPSN068fc913-779d-44c6-9585-3aa80e751bee1
1719862haloperidol decanoate 50 MG in 1 ML InjectionPSN068fc913-779d-44c6-9585-3aa80e751bee1
17198031 ML haloperidol decanoate 100 MG/ML InjectionSCD068fc913-779d-44c6-9585-3aa80e751bee1
17198621 ML haloperidol decanoate 50 MG/ML InjectionSCD068fc913-779d-44c6-9585-3aa80e751bee1
859871haloperidol decanoate 100 MG/ML Injectable SolutionSCD068fc913-779d-44c6-9585-3aa80e751bee1
859871haloperidol 100 MG/ML (as haloperidol decanoate) Injectable SolutionSY068fc913-779d-44c6-9585-3aa80e751bee1
1719803haloperidol decanoate 100 MG per 1 ML InjectionSY068fc913-779d-44c6-9585-3aa80e751bee1
1719862haloperidol decanoate 50 MG per 1 ML InjectionSY068fc913-779d-44c6-9585-3aa80e751bee1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70069-867-01700690867011 mL in 1 VIAL1 mlHistorical
70069-867-05700690867055 CARTON in 1 CARTON (70069-867-05) / 10 VIAL in 1 CARTON (70069-867-10) / 1 mL in 1 VIAL (70069-867-01) 5 carton2025-09-29NoNoCurrent
70069-867-107006908671010 in 1 CARTONHistorical