Haloperidol Decanoate

Product NDC: 70518-4240
11-digit product format: 705184240
Labeler code: 70518
Product ID: 70518-4240_4006fb6f-a731-50ea-e063-6394a90a5124
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Haloperidol Decanoate
Dosage form: INJECTION
Route: INTRAMUSCULAR
Labeler: REMEDYREPACK INC.
Application: ANDA216730
Marketing category: ANDA
Marketing start: 2024-12-16
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

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	100 mg/mL

Harmonized Identifiers#

Field, Values table
Field	Values
Unii	AC20PJ4101
Rxcui	1719803

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
70518-4240-0	Haloperidol Decanoate	10 in 1 CARTON	INJECTION	10		3
70518-4240-1	Haloperidol Decanoate	1 mL in 1 VIAL	INJECTION	1		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70518-4240	HALOPERIDOL DECANOATE INJECTION [REMEDYREPACK INC.]	1	Current NDC, 2 package rows	20241218_2cdd9fca-afe5-4bfa-8db1-337beec13c6b.zip

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	2cdd9fca-afe5-4bfa-8db1-337beec13c6b	3
1719803	1 ML haloperidol decanoate 100 MG/ML Injection	SCD	2cdd9fca-afe5-4bfa-8db1-337beec13c6b	3
1719803	haloperidol decanoate 100 MG per 1 ML Injection	SY	2cdd9fca-afe5-4bfa-8db1-337beec13c6b	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
70518-4240-0	70518424000	10 VIAL in 1 CARTON (70518-4240-0) / 1 mL in 1 VIAL (70518-4240-1)	10 vial	2024-12-16	No	No	Historical
70518-4240-1	70518424001	1 mL in 1 VIAL	1 ml				Historical