HALOPERIDOL DECANOATE

Product NDC: 70069-866
11-digit product format: 700690866
Labeler code: 70069
Product ID: 70069-866_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: 50 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-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A219168-001	HALOPERIDOL DECANOATE	HALOPERIDOL DECANOATE	EQ 50MG BASE/ML	INJECTABLE / INJECTION	AO		2025-05-13
A219168-002	HALOPERIDOL DECANOATE	HALOPERIDOL DECANOATE	EQ 100MG BASE/ML	INJECTABLE / INJECTION	AO		2025-05-13

Therapeutic equivalence codes#

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

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

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
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A219168-001	HALOPERIDOL DECANOATE	EQ 50MG BASE/ML	INJECTABLE / INJECTION	AO	2025-05-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A219168-002	HALOPERIDOL DECANOATE	EQ 100MG BASE/ML	INJECTABLE / INJECTION	AO	2025-05-13	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A219168-001	HALOPERIDOL DECANOATE	EQ 50MG BASE/ML	INJECTABLE / INJECTION	AO	2025-05-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A219168-002	HALOPERIDOL DECANOATE	EQ 100MG BASE/ML	INJECTABLE / INJECTION	AO	2025-05-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A219168-001	HALOPERIDOL DECANOATE	EQ 50MG BASE/ML	INJECTABLE / INJECTION	AO	2025-05-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A219168-002	HALOPERIDOL DECANOATE	EQ 100MG BASE/ML	INJECTABLE / INJECTION	AO	2025-05-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A219168-001	HALOPERIDOL DECANOATE	EQ 50MG BASE/ML	INJECTABLE / INJECTION	AO	2025-05-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A219168-002	HALOPERIDOL DECANOATE	EQ 100MG BASE/ML	INJECTABLE / INJECTION	AO	2025-05-13	`6a471c1ec25d…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A219168-001	HALOPERIDOL DECANOATE	EQ 50MG BASE/ML	INJECTABLE / INJECTION	AO	2025-05-13	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A219168-002	HALOPERIDOL DECANOATE	EQ 100MG BASE/ML	INJECTABLE / INJECTION	AO	2025-05-13	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A219168-001	AO	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A219168-002	AO	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A219168-001	AO	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A219168-002	AO	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A219168-001	AO	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A219168-002	AO	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A219168-001	AO	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A219168-002	AO	1	`6a471c1ec25d…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A219168-001	AO	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A219168-002	AO	1	`a50c72e98297…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
HALOPERIDOL DECANOATE	50 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
AC20PJ4101	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 3 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
068fc913-779d-44c6-9585-3aa80e751bee	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
d599bae4-cb25-0798-7468-31aa188fb750	Product name	7	20260304
6aae29ef-bf3c-3ebb-3bf1-10ee5424a22e	Product name	2	20250114
af58e43a-5792-c2c1-8e57-a2454df1f2c0	Product name	3	20240202
ce329990-eb12-45a5-87d5-ce5ef054ca71	Product name	2	20190930
9869efd7-d6dd-0665-5b67-53adbe6ef15e	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
70069-866-01	HALOPERIDOL DECANOATE	1 mL in 1 VIAL	INJECTION	1		1
70069-866-10	HALOPERIDOL DECANOATE	10 in 1 CARTON	INJECTION	10		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
70069-866-01	ML - Milliliter	70069-866	214be456-6e12-4519-ba2e-8d975b0082bf	1	2025-11-13
70069-866-10	ML - Milliliter	70069-866	ea709ff6-ae03-4a72-a863-51911f91cfd2	1	2025-11-13

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Haloperidol Decanoate	HALOPERIDOL DECANOATE	Armas Pharmaceuticals Inc.	80d51d2c-30e4-4eef-b184-0cebb30ca429	2026-05-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 219168 application number: ANDA219168
Haloperidol Decanoate	HALOPERIDOL DECANOATE	Armas Pharmaceuticals Inc.	9979e28f-2716-4788-8605-16f6edf158b5	2026-05-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 219168 application number: ANDA219168
Haloperidol Decanoate	HALOPERIDOL DECANOATE	REMEDYREPACK INC.	15b82169-882b-40ef-bbda-5adc3e7eb930	2026-03-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 219168 application number: ANDA219168
HALOPERIDOL DECANOATE	HALOPERIDOL DECANOATE	Somerset Therapeutics, LLC	068fc913-779d-44c6-9585-3aa80e751bee	2025-09-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 219168 application number: ANDA219168 ndc (product): 70069-866
Haloperidol Decanoate	HALOPERIDOL DECANOATE	Caplin Steriles Limited	4f9af14a-38c4-4826-aca0-3501edb854e3	2025-05-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 219168 application number: ANDA219168
Haloperidol Decanoate	HALOPERIDOL DECANOATE	Armas Pharmaceuticals Inc.	f9876b88-3caa-4c08-9a59-9b4a455e101d	2025-05-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 219168 application number: ANDA219168

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
AC20PJ4101	HALOPERIDOL DECANOATE	74050-97-8	HALOPERIDOL DECANOATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1719803	haloperidol decanoate 100 MG in 1 ML Injection	PSN	068fc913-779d-44c6-9585-3aa80e751bee	1
859871	haloperidol decanoate 100 MG/ML Injectable Solution	PSN	068fc913-779d-44c6-9585-3aa80e751bee	1
1719862	haloperidol decanoate 50 MG in 1 ML Injection	PSN	068fc913-779d-44c6-9585-3aa80e751bee	1
1719803	1 ML haloperidol decanoate 100 MG/ML Injection	SCD	068fc913-779d-44c6-9585-3aa80e751bee	1
1719862	1 ML haloperidol decanoate 50 MG/ML Injection	SCD	068fc913-779d-44c6-9585-3aa80e751bee	1
859871	haloperidol decanoate 100 MG/ML Injectable Solution	SCD	068fc913-779d-44c6-9585-3aa80e751bee	1
859871	haloperidol 100 MG/ML (as haloperidol decanoate) Injectable Solution	SY	068fc913-779d-44c6-9585-3aa80e751bee	1
1719803	haloperidol decanoate 100 MG per 1 ML Injection	SY	068fc913-779d-44c6-9585-3aa80e751bee	1
1719862	haloperidol decanoate 50 MG per 1 ML Injection	SY	068fc913-779d-44c6-9585-3aa80e751bee	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
70069-866-01	70069086601	1 mL in 1 VIAL	1 ml				Historical
70069-866-10	70069086610	10 VIAL in 1 CARTON (70069-866-10) / 1 mL in 1 VIAL (70069-866-01)	10 vial	2025-09-29	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Haloperidol Decanoate Injection For Intramuscular Injection Only Rx Only	Somerset Therapeutics, LLC \| Caplin Steriles Limited	2025-09-30	HUMAN PRESCRIPTION DRUG LABEL	1