FDA.reportPublic FDA data

allergy relief

Product NDC
37808-847
11-digit product format
378080847
Labeler code
37808
Product ID
37808-847_5857482f-bc9f-472a-b86b-ec2e2b83f6dc
Type
HUMAN OTC DRUG
Nonproprietary name
fexofenadine hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
H E B
Application
ANDA212971
Marketing category
ANDA
Marketing start
2021-12-22
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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
b893258d-0942-3d8a-3411-056ea0788ff5Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
37808-847-22allergy relief15 in 1 CARTONTABLET, FILM COATED152
37808-847-22allergy relief1 in 1 BLISTER PACKTABLET, FILM COATED12
37808-847-39allergy relief1 in 1 CARTONTABLET, FILM COATED12
37808-847-39allergy relief30 in 1 BOTTLETABLET, FILM COATED302
37808-847-49allergy relief40 in 1 BOTTLETABLET, FILM COATED402
37808-847-49allergy relief1 in 1 CARTONTABLET, FILM COATED12
37808-847-95allergy relief1 in 1 CARTONTABLET, FILM COATED12
37808-847-95allergy relief45 in 1 BOTTLETABLET, FILM COATED452

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
37808-847ALLERGY RELIEF (FEXOFENADINE HYDROCHLORIDE) TABLET, FILM COATED [H E B]2Current NDC, Legacy NDC, 8 package rows20220107_1930968f-6dac-463d-ab01-f5334d75cb28.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
997420fexofenadine HCl 180 MG 24 HR Oral TabletPSN1930968f-6dac-463d-ab01-f5334d75cb282
997420fexofenadine hydrochloride 180 MG Oral TabletSCD1930968f-6dac-463d-ab01-f5334d75cb282
997420fexofenadine HCl 180 MG 24 HR Oral TabletSY1930968f-6dac-463d-ab01-f5334d75cb282

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
37808-847-223780808472215 BLISTER PACK in 1 CARTON (37808-847-22) / 1 TABLET, FILM COATED in 1 BLISTER PACK15 blister pack2021-12-220000-00-00NoNoCurrent
37808-847-39378080847391 BOTTLE in 1 CARTON (37808-847-39) / 30 TABLET, FILM COATED in 1 BOTTLE1 bottle2021-12-220000-00-00NoNoCurrent
37808-847-49378080847491 BOTTLE in 1 CARTON (37808-847-49) / 40 TABLET, FILM COATED in 1 BOTTLE1 bottle2021-12-300000-00-00NoNoCurrent
37808-847-95378080847951 BOTTLE in 1 CARTON (37808-847-95) / 45 TABLET, FILM COATED in 1 BOTTLE1 bottle2021-12-220000-00-00NoNoCurrent