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Product NDC

55316-571

11-digit product format

553160571

Labeler code

55316

Product ID

55316-571_6ebf2d84-3c95-41e5-90d6-01bb70e3aaf1

Type

HUMAN OTC DRUG

Nonproprietary name

fexofenadine hydrochloride

Dosage form

TABLET, FILM COATED

Route

ORAL

Labeler

DZA Brands LLC

Application

ANDA076447

Marketing category

ANDA

Marketing start

2011-06-15

Marketing end

2019-08-31

Substance

FEXOFENADINE HYDROCHLORIDE

Active strength

180 mg/1

NDC exclude flag

No

Listing certified through

0000-00-00

Current FDA listing

Historical FDA.report record