FDA.reportPublic FDA data

Allergy Relief

Product NDC
36800-653
11-digit product format
368000653
Labeler code
36800
Product ID
36800-653_08f3ce32-81a9-f9d2-e063-6394a90ab17d
Type
HUMAN OTC DRUG
Nonproprietary name
Fexofenadine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
TOPCO ASSOCIATES LLC
Application
ANDA211075
Marketing category
ANDA
Marketing start
2021-08-31
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
Allergy Relief
Listing expiration
2026-12-31

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
36800-653-03Allergy Relief1 in 1 CARTONTABLET16
36800-653-03Allergy Relief15 in 1 BLISTER PACKTABLET156
36800-653-06Allergy Relief45 in 1 BOTTLE, PLASTICTABLET456
36800-653-06Allergy Relief1 in 1 CARTONTABLET16
36800-653-07Allergy Relief1 in 1 CARTONTABLET16
36800-653-07Allergy Relief60 in 1 BOTTLE, PLASTICTABLET606
36800-653-11Allergy Relief1 in 1 CARTONTABLET16
36800-653-11Allergy Relief150 in 1 BOTTLE, PLASTICTABLET1506
36800-653-14Allergy Relief180 in 1 BOTTLE, PLASTICTABLET1806
36800-653-16Allergy Relief2 in 1 CARTONTABLET26
36800-653-16Allergy Relief30 in 1 BOTTLE, PLASTICTABLET306

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
36800-653ALLERGY RELIEF (FEXOFENADINE HYDROCHLORIDE) TABLET [TOPCO ASSOCIATES LLC]6Current NDC, Legacy NDC, 11 package rows20231031_c4f9224c-4c3d-74bd-e053-2995a90a1452.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
997420fexofenadine HCl 180 MG 24 HR Oral TabletPSNc4f9224c-4c3d-74bd-e053-2995a90a14526
997420fexofenadine hydrochloride 180 MG Oral TabletSCDc4f9224c-4c3d-74bd-e053-2995a90a14526
997420fexofenadine HCl 180 MG 24 HR Oral TabletSYc4f9224c-4c3d-74bd-e053-2995a90a14526

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
36800-653-03368000653031 BLISTER PACK in 1 CARTON (36800-653-03) / 15 TABLET in 1 BLISTER PACK1 blister pack2021-09-100000-00-00NoNoCurrent
36800-653-06368000653061 BOTTLE, PLASTIC in 1 CARTON (36800-653-06) > 45 TABLET in 1 BOTTLE, PLASTIC2021-11-160000-00-00NoNoCurrent
36800-653-07368000653071 BOTTLE, PLASTIC in 1 CARTON (36800-653-07) / 60 TABLET in 1 BOTTLE, PLASTIC2022-12-080000-00-00NoNoCurrent
36800-653-11368000653111 BOTTLE, PLASTIC in 1 CARTON (36800-653-11) / 150 TABLET in 1 BOTTLE, PLASTIC2023-12-08NoNoCurrent
36800-653-1436800065314180 TABLET in 1 BOTTLE, PLASTIC (36800-653-14) 180 tablet2021-08-310000-00-00NoNoCurrent
36800-653-16368000653162 BOTTLE, PLASTIC in 1 CARTON (36800-653-16) > 30 TABLET in 1 BOTTLE, PLASTIC2021-08-310000-00-00NoNoCurrent