Haloperidol Decanoate

Product NDC: 72485-520
Requested package NDC: 72485-520-10
11-digit product format: 724850520
Labeler code: 72485
Product ID: 72485-520_f80ebd1c-e43e-4e6a-bbd0-96cfabafb548
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Haloperidol Decanoate
Dosage form: INJECTION
Route: INTRAMUSCULAR
Labeler: Armas Pharmaceuticals Inc.
Application: ANDA219168
Marketing category: ANDA
Marketing start: 2026-05-15
Substance: HALOPERIDOL DECANOATE
Active strength: 50 mg/mL
Pharmacologic classes: Typical Antipsychotic [EPC]
NDC exclude flag: No
Listing certified through: 2027-12-31
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 · 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
2026-02-19 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
2026-02-19 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: 2027-12-31

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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
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
9979e28f-2716-4788-8605-16f6edf158b5	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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
72485-520-01	Haloperidol Decanoate	1 mL in 1 VIAL, SINGLE-DOSE	INJECTION	1		1
72485-520-10	Haloperidol Decanoate	10 in 1 CARTON	INJECTION	10		1

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 ndc (package): 72485-520-10 ndc (product): 72485-520 ndc11 (package): 72485052010
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
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
1719862	haloperidol decanoate 50 MG in 1 ML Injection	PSN	9979e28f-2716-4788-8605-16f6edf158b5	1
1719862	1 ML haloperidol decanoate 50 MG/ML Injection	SCD	9979e28f-2716-4788-8605-16f6edf158b5	1
1719862	haloperidol decanoate 50 MG per 1 ML Injection	SY	9979e28f-2716-4788-8605-16f6edf158b5	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
72485-520-10	72485052010	10 VIAL, SINGLE-DOSE in 1 CARTON (72485-520-10) / 1 mL in 1 VIAL, SINGLE-DOSE (72485-520-01)	2026-05-15	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Haloperidol Decanoate Injection For Intramuscular Injection Only Rx Only	Armas Pharmaceuticals Inc.	2026-05-15	Human Prescription Drug Label	1