LEVOCETIRIZINE DIHYDROCHLORIDE

Product NDC: 68071-4629
11-digit product format: 680714629
Labeler code: 68071
Product ID: 68071-4629_8370f32e-a1a6-c0c2-e053-2991aa0aaa35
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: LEVOCETIRIZINE DIHYDROCHLORIDE
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: NuCare Pharmaceuticals,Inc.
Application: ANDA205564
Marketing category: ANDA
Marketing start: 2016-01-11
Marketing end: 0000-00-00
Substance: LEVOCETIRIZINE DIHYDROCHLORIDE
Active strength: 5 mg/1
Pharmacologic classes: Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC]
NDC exclude flag: No
Listing certified through: 2020-12-31
Current FDA listing: Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
36cf9111-9cc4-8f59-a74c-0c1cfbd4a760	Product name	7	20190702

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
68071-4629-9	2021-01-29	C162847	48780-1	ba0f9c33-1a42-a910-e053-dadaa90a0b85	These highlights do not include all the information needed to use LEVOCETIRIZINE DIHYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for LEVOCETIRIZINE DIHYDROCHLORIDE TABLETS. LEVOCETIRIZINE dihydrochloride tablets, for oral use Initial U.S. Approval: 1995

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68071-4629-9	LEVOCETIRIZINE DIHYDROCHLORIDE	90 in 1 BOTTLE	TABLET, FILM COATED	90		4

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68071-4629	LEVOCETIRIZINE DIHYDROCHLORIDE TABLET, FILM COATED [NUCARE PHARMACEUTICALS,INC.]	4	Legacy NDC, 1 package rows	20190307_7a7dae67-6e24-511a-e053-2a91aa0acb44.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
SOD6A38AGA	LEVOCETIRIZINE DIHYDROCHLORIDE	130018-87-0	LEVOCETIRIZINE DIHYDROCHLORIDE

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
855172	levocetirizine dihydrochloride 5 MG Oral Tablet	PSN	7a7dae67-6e24-511a-e053-2a91aa0acb44	4
855172	levocetirizine dihydrochloride 5 MG Oral Tablet	SCD	7a7dae67-6e24-511a-e053-2a91aa0acb44	4
855172	levocetirizine dihydrochloride 5 MG 24 HR Oral Tablet	SY	7a7dae67-6e24-511a-e053-2a91aa0acb44	4

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
68071-4629-9	68071462909	90 in 1 BOTTLE	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
LEVOCETIRIZINE DIHYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	2019-03-06	HUMAN PRESCRIPTION DRUG LABEL	4