FDA.reportPublic FDA data

Fexofenadine hydrochloride

Product NDC
0904-6711
11-digit product format
009046711
Labeler code
0904
Product ID
0904-6711_dad01df2-a6b4-5fac-8c6a-d49c1166892f
Type
HUMAN OTC DRUG
Nonproprietary name
Fexofenadine hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
MAJOR PHARMACEUTICALS
Application
ANDA076502
Marketing category
ANDA
Marketing start
2018-04-27
Marketing end
2026-08-31
Substance
FEXOFENADINE HYDROCHLORIDE
Active strength
180 mg/1
Pharmacologic classes
Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Fexofenadine hydrochloride

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
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
b893258d-0942-3d8a-3411-056ea0788ff5Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-6711-10EA - Each0904-671156de4c7c-23d9-4369-abc2-3114e81fcfc012018-07-03
0904-6711-46EA - Each0904-67115b08a7bc-f4fb-4a01-b6f5-babad252e26d12018-06-11
0904-6711-52EA - Each0904-671180a2a7aa-ef12-445e-9fea-db6863ea077412018-11-06
0904-6711-89EA - Each0904-67111da6e8a0-acc1-4089-911f-c83b24b988be12018-06-11
0904-6711-92EA - Each0904-67115b981999-07ae-4d33-bb76-2c96a890639d12019-03-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0904-6711FEXOFENADINE HYDROCHLORIDE TABLET [MAJOR PHARMACEUTICALS]4Current NDC, Legacy NDC20241114_0a6da401-a8a3-5d0b-f37e-c220838f7e49.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
997420fexofenadine HCl 180 MG 24 HR Oral TabletPSN0a6da401-a8a3-5d0b-f37e-c220838f7e495
997420fexofenadine hydrochloride 180 MG Oral TabletSCD0a6da401-a8a3-5d0b-f37e-c220838f7e495
997420fexofenadine HCl 180 MG 24 HR Oral TabletSY0a6da401-a8a3-5d0b-f37e-c220838f7e495

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0904-6711-10009046711103 BLISTER PACK in 1 CARTON (0904-6711-10) > 5 TABLET in 1 BLISTER PACK3 blister pack2018-04-270000-00-00NoNoCurrent
0904-6711-46009046711461 BOTTLE in 1 CARTON (0904-6711-46) / 30 TABLET in 1 BOTTLE1 bottle2018-04-272026-08-31NoNoCurrent
0904-6711-52009046711522 BOTTLE in 1 CARTON (0904-6711-52) > 30 TABLET in 1 BOTTLE2 bottle2018-04-270000-00-00NoNoCurrent
0904-6711-89009046711891 BOTTLE in 1 CARTON (0904-6711-89) > 90 TABLET in 1 BOTTLE1 bottle2018-04-270000-00-00NoNoCurrent
0904-6711-92009046711921 BOTTLE in 1 CARTON (0904-6711-92) > 150 TABLET in 1 BOTTLE1 bottle2018-04-270000-00-00NoNoCurrent