FDA.reportPublic FDA data

Fexofenadine hydrochloride

Product NDC
68001-439
11-digit product format
680010439
Labeler code
68001
Product ID
68001-439_bd31cd71-9281-7667-e053-2995a90a4ac0
Type
HUMAN OTC DRUG
Nonproprietary name
Fexofenadine hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
BluePoint Laboratories
Application
ANDA076502
Marketing category
ANDA
Marketing start
2020-06-19
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 hydrochloride
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
68001-439-00Fexofenadine hydrochloride100 in 1 BOTTLETABLET1002
68001-439-00Fexofenadine hydrochloride1 in 1 CARTONTABLET12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68001-439-00EA - Each68001-43962c873d1-5a8e-4c1f-85bb-9bb11fcbabed12020-09-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68001-439FEXOFENADINE HYDROCHLORIDE TABLET [BLUEPOINT LABORATORIES]2Current NDC, Legacy NDC, 2 package rows20210317_a86aebd0-937e-5d73-e053-2995a90a656a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
997420fexofenadine HCl 180 MG 24 HR Oral TabletPSNa86aebd0-937e-5d73-e053-2995a90a656a2
997501fexofenadine HCl 60 MG Oral TabletPSNa86aebd0-937e-5d73-e053-2995a90a656a2
997420fexofenadine hydrochloride 180 MG Oral TabletSCDa86aebd0-937e-5d73-e053-2995a90a656a2
997501fexofenadine hydrochloride 60 MG Oral TabletSCDa86aebd0-937e-5d73-e053-2995a90a656a2
997420fexofenadine HCl 180 MG 24 HR Oral TabletSYa86aebd0-937e-5d73-e053-2995a90a656a2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68001-439-00680010439001 BOTTLE in 1 CARTON (68001-439-00) / 100 TABLET in 1 BOTTLE1 bottle2020-06-190000-00-00NoNoCurrent