FDA.reportPublic FDA data

topcare allergy relief

Product NDC
36800-691
11-digit product format
368000691
Labeler code
36800
Product ID
36800-691_9cb64047-5e7e-4fbc-913a-e3831cf557f4
Type
HUMAN OTC DRUG
Nonproprietary name
fexofenadine hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Topco Associates LLC
Application
ANDA212971
Marketing category
ANDA
Marketing start
2021-08-23
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
topcare 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
36800-691-13topcare allergy relief5 in 1 CARTONTABLET, FILM COATED53
36800-691-13topcare allergy relief1 in 1 BLISTER PACKTABLET, FILM COATED13
36800-691-22topcare allergy relief1 in 1 BLISTER PACKTABLET, FILM COATED13
36800-691-22topcare allergy relief15 in 1 CARTONTABLET, FILM COATED153
36800-691-39topcare allergy relief1 in 1 CARTONTABLET, FILM COATED13
36800-691-39topcare allergy relief30 in 1 BOTTLETABLET, FILM COATED303
36800-691-49topcare allergy relief40 in 1 BOTTLETABLET, FILM COATED403
36800-691-49topcare allergy relief1 in 1 CARTONTABLET, FILM COATED13
36800-691-75topcare allergy relief1 in 1 CARTONTABLET, FILM COATED13
36800-691-75topcare allergy relief90 in 1 BOTTLETABLET, FILM COATED903
36800-691-95topcare allergy relief45 in 1 BOTTLETABLET, FILM COATED453
36800-691-95topcare allergy relief1 in 1 CARTONTABLET, FILM COATED13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
36800-691TOPCARE ALLERGY RELIEF (FEXOFENADINE HYDROCHLORIDE) TABLET, FILM COATED [TOPCO ASSOCIATES LLC]2Current NDC, Legacy NDC, 12 package rows20210925_e7658b5f-2d78-4f25-b1a3-e49198ca8f32.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
997420fexofenadine HCl 180 MG 24 HR Oral TabletPSNe7658b5f-2d78-4f25-b1a3-e49198ca8f323
997420fexofenadine hydrochloride 180 MG Oral TabletSCDe7658b5f-2d78-4f25-b1a3-e49198ca8f323
997420fexofenadine HCl 180 MG 24 HR Oral TabletSYe7658b5f-2d78-4f25-b1a3-e49198ca8f323

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
36800-691-13368000691135 BLISTER PACK in 1 CARTON (36800-691-13) > 1 TABLET, FILM COATED in 1 BLISTER PACK5 blister pack2021-08-270000-00-00NoNoCurrent
36800-691-223680006912215 BLISTER PACK in 1 CARTON (36800-691-22) > 1 TABLET, FILM COATED in 1 BLISTER PACK15 blister pack2021-09-210000-00-00NoNoCurrent
36800-691-39368000691391 BOTTLE in 1 CARTON (36800-691-39) / 30 TABLET, FILM COATED in 1 BOTTLE1 bottle2021-08-230000-00-00NoNoCurrent
36800-691-49368000691491 BOTTLE in 1 CARTON (36800-691-49) / 40 TABLET, FILM COATED in 1 BOTTLE1 bottle2021-09-210000-00-00NoNoCurrent
36800-691-75368000691751 BOTTLE in 1 CARTON (36800-691-75) / 90 TABLET, FILM COATED in 1 BOTTLE1 bottle2021-09-210000-00-00NoNoCurrent
36800-691-95368000691951 BOTTLE in 1 CARTON (36800-691-95) > 45 TABLET, FILM COATED in 1 BOTTLE1 bottle2021-09-210000-00-00NoNoCurrent