Haloperidol

Product NDC: 68258-7077
11-digit product format: 682587077
Labeler code: 68258
Product ID: 68258-7077_1a577f08-1a85-45a0-81b9-265be154dc66
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Haloperidol
Dosage form: TABLET
Route: ORAL
Labeler: Dispensing Solutions, Inc.
Application: ANDA071207
Marketing category: ANDA
Marketing start: 1986-11-17
Marketing end: 0000-00-00
Substance: HALOPERIDOL
Active strength: 1 mg/1
Pharmacologic classes: Typical Antipsychotic [EPC]
NDC exclude flag: E
Listing certified through: 2017-12-31
Current FDA listing: Historical FDA.report record

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
68258-7077-3	2019-11-13	C162847	48780-1	97449f38-cd01-f6ea-e053-dbdaa90aa703	Haloperidol Tablets, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68258-7077-3	Haloperidol	30 in 1 BOTTLE	TABLET	30		1

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version	Uploaded
HALOPERIDOL	ACTIVE INGREDIENT	J6292F8L3D	HALOPERIDOL TABLET [DISPENSING SOLUTIONS, INC.]	1
HALOPERIDOL	ACTIVE MOIETY	J6292F8L3D	HALOPERIDOL TABLET [DISPENSING SOLUTIONS, INC.]	1
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	HALOPERIDOL TABLET [DISPENSING SOLUTIONS, INC.]	1
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	HALOPERIDOL TABLET [DISPENSING SOLUTIONS, INC.]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	HALOPERIDOL TABLET [DISPENSING SOLUTIONS, INC.]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	HALOPERIDOL TABLET [DISPENSING SOLUTIONS, INC.]	1
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	HALOPERIDOL TABLET [DISPENSING SOLUTIONS, INC.]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	HALOPERIDOL TABLET [DISPENSING SOLUTIONS, INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68258-7077	HALOPERIDOL TABLET [DISPENSING SOLUTIONS, INC.]	1	Legacy NDC, 1 package rows	20111007_bd2a2749-4f93-400a-a06d-db7b8115ebad.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
310671	haloperidol 1 MG Oral Tablet	PSN	bd2a2749-4f93-400a-a06d-db7b8115ebad	1
310671	haloperidol 1 MG Oral Tablet	SCD	bd2a2749-4f93-400a-a06d-db7b8115ebad	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
68258-7077-3	68258707703	30 in 1 BOTTLE	Historical