FDA.reportPublic FDA data

fexofenadine hcl

Product NDC
0904-7486
11-digit product format
009047486
Labeler code
0904
Product ID
0904-7486_b1390973-4ac1-40c9-b0e1-c7a4d04c0ee4
Type
HUMAN OTC DRUG
Nonproprietary name
fexofenadine hcl
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Major Pharmaceuticals
Application
ANDA204507
Marketing category
ANDA
Marketing start
2024-08-20
Substance
FEXOFENADINE HYDROCHLORIDE
Active strength
180 mg/1
Pharmacologic classes
Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
fexofenadine hcl
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FEXOFENADINE HYDROCHLORIDE180 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii2S068B75ZU
Rxcui997420, 997501

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
b893258d-0942-3d8a-3411-056ea0788ff5Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0904-7486-02fexofenadine hcl30 in 1 BOTTLETABLET, FILM COATED306
0904-7486-40fexofenadine hcl500 in 1 BOTTLETABLET, FILM COATED5006
0904-7486-60fexofenadine hcl100 in 1 BOTTLETABLET, FILM COATED1006

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-7486-02EA - Each0904-74867edb5776-4bf9-4d02-899f-3d109c73a34512025-05-14
0904-7486-40EA - Each0904-7486ddf71941-ebd0-4d39-b97b-b65ea1b2573612024-12-10
0904-7486-60EA - Each0904-74866b6e07ac-5126-4aef-832b-2529d7d6fb7712024-11-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0904-7486FEXOFENADINE HCL TABLET, FILM COATED [MAJOR PHARMACEUTICALS]3Current NDC, 3 package rows20240822_107f398c-f296-4190-8234-82556a039e65.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
997420fexofenadine HCl 180 MG 24 HR Oral TabletPSN107f398c-f296-4190-8234-82556a039e656
997501fexofenadine HCl 60 MG Oral TabletPSN107f398c-f296-4190-8234-82556a039e656
997420fexofenadine hydrochloride 180 MG Oral TabletSCD107f398c-f296-4190-8234-82556a039e656
997501fexofenadine hydrochloride 60 MG Oral TabletSCD107f398c-f296-4190-8234-82556a039e656
997420fexofenadine HCl 180 MG 24 HR Oral TabletSY107f398c-f296-4190-8234-82556a039e656
997420fexofenadine HCl 180 MG 24 HR Oral TabletPSN31e71ee7-c4b5-6c1c-e063-6294a90a15131
997420fexofenadine hydrochloride 180 MG Oral TabletSCD31e71ee7-c4b5-6c1c-e063-6294a90a15131
997420fexofenadine HCl 180 MG 24 HR Oral TabletSY31e71ee7-c4b5-6c1c-e063-6294a90a15131

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
0904-7486-020090474860230 TABLET, FILM COATED in 1 BOTTLE (0904-7486-02) 2024-08-20NoNoHistorical
0904-7486-4000904748640500 TABLET, FILM COATED in 1 BOTTLE (0904-7486-40) 2024-08-20NoNoHistorical
0904-7486-6000904748660100 TABLET, FILM COATED in 1 BOTTLE (0904-7486-60) 2024-08-20NoNoHistorical