Haloperidol

Product NDC: 70518-3021
11-digit product format: 705183021
Labeler code: 70518
Product ID: 70518-3021_4af336d0-4aac-a0c8-e063-6394a90a4f51
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Haloperidol
Dosage form: TABLET
Route: ORAL
Labeler: REMEDYREPACK INC.
Application: ANDA071173
Marketing category: ANDA
Marketing start: 2021-02-10
Substance: HALOPERIDOL
Active strength: 20 mg/1
Pharmacologic classes: Typical Antipsychotic [EPC]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

Additional Listing Data#

Finished product: Yes
Brand name base: Haloperidol
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
HALOPERIDOL	20 mg/1

Harmonized Identifiers#

Field, Values table
Field	Values
Unii	J6292F8L3D
Rxcui	197754

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
70518-3021-0	2023-03-14	C162847	48780-1	f386c64a-4a0c-0266-e053-dadaa90a7c1a	Haloperidol Tablets, USP
70518-3021-0	2023-01-30	C162847	48780-1	f386c64a-4a0c-0266-e053-dadaa90a7c1a	Haloperidol Tablets, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
70518-3021-0	Haloperidol	30 in 1 BLISTER PACK	TABLET	30		8
70518-3021-1	Haloperidol	100 in 1 BOX	TABLET	100		8
70518-3021-2	Haloperidol	1 in 1 POUCH	TABLET	1		8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70518-3021	HALOPERIDOL TABLET [REMEDYREPACK INC.]	5	Current NDC, Legacy NDC, 3 package rows	20250409_051f3c99-7d16-4185-a857-c90440e1b1c5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
197754	haloperidol 20 MG Oral Tablet	PSN	051f3c99-7d16-4185-a857-c90440e1b1c5	8
197754	haloperidol 20 MG Oral Tablet	SCD	051f3c99-7d16-4185-a857-c90440e1b1c5	8

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
70518-3021-0	70518302100	30 TABLET in 1 BLISTER PACK (70518-3021-0)	30 tablet	2021-02-10	0000-00-00	No	No	Current
70518-3021-1	70518302101	100 in 1 BOX						Historical
70518-3021-2	70518302102	1 in 1 POUCH						Historical