FDA.reportPublic FDA data

Allergy Relief

Product NDC
59726-801
11-digit product format
597260801
Labeler code
59726
Product ID
59726-801_c2f7e42a-1f5d-46f4-94a4-370780de7823
Type
HUMAN OTC DRUG
Nonproprietary name
Fexofenadine HCl
Dosage form
TABLET, COATED
Route
ORAL
Labeler
P & L Development, LLC
Application
ANDA204507
Marketing category
ANDA
Marketing start
2021-08-20
Marketing end
2026-12-30
Substance
FEXOFENADINE HYDROCHLORIDE
Active strength
180 mg/1
Pharmacologic classes
Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Allergy Relief

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FEXOFENADINE HYDROCHLORIDE180 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii2S068B75ZU
Rxcui997420

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
59726-801-03Allergy Relief3 in 1 CARTONTABLET, COATED36
59726-801-03Allergy Relief1 in 1 BLISTER PACKTABLET, COATED16
59726-801-12Allergy Relief120 in 1 CARTONTABLET, COATED1206
59726-801-12Allergy Relief1 in 1 BLISTER PACKTABLET, COATED16
59726-801-15Allergy Relief15 in 1 CARTONTABLET, COATED156
59726-801-15Allergy Relief1 in 1 BLISTER PACKTABLET, COATED16
59726-801-30Allergy Relief30 in 1 BOTTLE, PLASTICTABLET, COATED306
59726-801-30Allergy Relief1 in 1 BOXTABLET, COATED16
59726-801-70Allergy Relief70 in 1 BOTTLE, PLASTICTABLET, COATED706
59726-801-70Allergy Relief1 in 1 BOXTABLET, COATED16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59726-801ALLERGY RELIEF (FEXOFENADINE HCL) TABLET, COATED [P & L DEVELOPMENT, LLC]5Current NDC, Legacy NDC, 10 package rows20230317_a976ad95-33d2-49f5-bad5-e980bf764879.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
997420fexofenadine HCl 180 MG 24 HR Oral TabletPSNa976ad95-33d2-49f5-bad5-e980bf7648796
997420fexofenadine hydrochloride 180 MG Oral TabletSCDa976ad95-33d2-49f5-bad5-e980bf7648796
997420fexofenadine HCl 180 MG 24 HR Oral TabletSYa976ad95-33d2-49f5-bad5-e980bf7648796

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59726-801-03597260801033 BLISTER PACK in 1 CARTON (59726-801-03) / 1 TABLET, COATED in 1 BLISTER PACK3 blister pack2021-08-202026-12-30NoNoCurrent
59726-801-1259726080112120 BLISTER PACK in 1 CARTON (59726-801-12) / 1 TABLET, COATED in 1 BLISTER PACK120 blister pack2021-08-202026-12-30NoNoCurrent
59726-801-155972608011515 BLISTER PACK in 1 CARTON (59726-801-15) / 1 TABLET, COATED in 1 BLISTER PACK15 blister pack2021-08-202026-12-30NoNoCurrent
59726-801-30597260801301 BOTTLE, PLASTIC in 1 BOX (59726-801-30) / 30 TABLET, COATED in 1 BOTTLE, PLASTIC2021-08-202026-12-30NoNoHistorical
59726-801-70597260801701 BOTTLE, PLASTIC in 1 BOX (59726-801-70) / 70 TABLET, COATED in 1 BOTTLE, PLASTIC2021-08-202026-12-30NoNoCurrent