FDA.reportPublic FDA data

fexofenadine hcl

Product NDC
0904-7192
11-digit product format
009047192
Labeler code
0904
Product ID
0904-7192_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
2021-08-26
Substance
FEXOFENADINE HYDROCHLORIDE
Active strength
60 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 HYDROCHLORIDE60 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
0904-7192-04fexofenadine hcl100 in 1 BOTTLETABLET, FILM COATED1006
0904-7192-40fexofenadine hcl500 in 1 BOTTLETABLET, FILM COATED5006
0904-7192-60fexofenadine hcl100 in 1 BOTTLETABLET, FILM COATED1006

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-7192-04EA - Each0904-719285db12f5-e179-453f-b8c1-747c6861e88112025-05-14
0904-7192-40EA - Each0904-7192e5e0aeaa-32d3-496e-b3b6-f50b8428005812021-11-09
0904-7192-60EA - Each0904-7192a974ee96-c7f8-4310-a92f-1b19ec66d3a812021-11-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0904-7192FEXOFENADINE HCL TABLET, FILM COATED [MAJOR PHARMACEUTICALS]3Current NDC, Legacy NDC, 3 package rows20240822_107f398c-f296-4190-8234-82556a039e65.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
997501fexofenadine HCl 60 MG Oral TabletPSNc23ad304-a5de-454e-a135-4eb143af2381104
997501fexofenadine hydrochloride 60 MG Oral TabletSCDc23ad304-a5de-454e-a135-4eb143af2381104
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
997501fexofenadine HCl 60 MG Oral TabletPSNd56af33f-189d-19c4-e053-2a95a90a14611
997501fexofenadine hydrochloride 60 MG Oral TabletSCDd56af33f-189d-19c4-e053-2a95a90a14611

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0904-7192-0400904719204100 TABLET, FILM COATED in 1 BOTTLE (0904-7192-04) 2024-08-20NoNoCurrent
0904-7192-4000904719240500 TABLET, FILM COATED in 1 BOTTLE (0904-7192-40) 2021-08-260000-00-00NoNoCurrent
0904-7192-6000904719260100 TABLET, FILM COATED in 1 BOTTLE (0904-7192-60) 2021-08-260000-00-00NoNoCurrent