FDA.reportPublic FDA data

Fexofenadine HCl

Product NDC
68016-119
11-digit product format
680160119
Labeler code
68016
Product ID
68016-119_3b3fd1c4-ca83-4ef3-9db3-785d17c315a4
Type
HUMAN OTC DRUG
Nonproprietary name
Fexofenadine HCl
Dosage form
TABLET
Route
ORAL
Labeler
Chain Drug Consortium, LLC
Application
ANDA079112
Marketing category
ANDA
Marketing start
2012-06-18
Marketing end
0000-00-00
Substance
FEXOFENADINE HYDROCHLORIDE
Active strength
180 mg/1
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct68016-119DDiscontinued by firm2026-07-31
excluded packagepackage68016-11968016-119-00DDiscontinued by firm2026-07-31
excluded packagepackage68016-11968016-119-01DDiscontinued by firm2026-07-31

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 6 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A079112-001CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVESFEXOFENADINE HYDROCHLORIDE30MGTABLET / ORAL2012-02-08
A079112-002CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGYFEXOFENADINE HYDROCHLORIDE30MGTABLET / ORAL2012-02-08
A079112-003FEXOFENADINE HYDROCHLORIDE HIVESFEXOFENADINE HYDROCHLORIDE60MGTABLET / ORAL2012-02-08
A079112-004FEXOFENADINE HYDROCHLORIDE ALLERGYFEXOFENADINE HYDROCHLORIDE60MGTABLET / ORAL2012-02-08
A079112-005FEXOFENADINE HYDROCHLORIDE HIVESFEXOFENADINE HYDROCHLORIDE180MGTABLET / ORAL2012-02-08
A079112-006FEXOFENADINE HYDROCHLORIDE ALLERGYFEXOFENADINE HYDROCHLORIDE180MGTABLET / ORAL2012-02-08

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A079112-001CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES30MGTABLET / ORAL2012-02-08a50c72e98297…
2026-08-01 22:54:322026-06A079112-002CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY30MGTABLET / ORAL2012-02-08a50c72e98297…
2026-08-01 22:54:322026-06A079112-003FEXOFENADINE HYDROCHLORIDE HIVES60MGTABLET / ORAL2012-02-08a50c72e98297…
2026-08-01 22:54:322026-06A079112-004FEXOFENADINE HYDROCHLORIDE ALLERGY60MGTABLET / ORAL2012-02-08a50c72e98297…
2026-08-01 22:54:322026-06A079112-005FEXOFENADINE HYDROCHLORIDE HIVES180MGTABLET / ORAL2012-02-08a50c72e98297…
2026-08-01 22:54:322026-06A079112-006FEXOFENADINE HYDROCHLORIDE ALLERGY180MGTABLET / ORAL2012-02-08a50c72e98297…

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68016-119-002024-03-06C16284748780-19d75b9d0-ff25-f424-e053-dadaa90a57ceDRUG FACTS
68016-119-012024-03-06C16284748780-19d75b9d0-ff25-f424-e053-dadaa90a57ceDRUG FACTS
68016-119-002020-01-31C16284748780-19d75b9d0-ff25-f424-e053-dadaa90a57ceDRUG FACTS
68016-119-012020-01-31C16284748780-19d75b9d0-ff25-f424-e053-dadaa90a57ceDRUG FACTS

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68016-119-00EA - Each68016-1198b1b08d2-9ccb-471a-9672-cad1a86a612512022-06-06
68016-119-01EA - Each68016-11936cb03eb-8299-448f-bbd3-90f4a12f831d12013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FEXOFENADINE HYDROCHLORIDEACTIVE INGREDIENT2S068B75ZUFEXOFENADINE HCL TABLET [CHAIN DRUG CONSORTIUM, LLC]3
FEXOFENADINEACTIVE MOIETYE6582LOH6VFEXOFENADINE HCL TABLET [CHAIN DRUG CONSORTIUM, LLC]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UFEXOFENADINE HCL TABLET [CHAIN DRUG CONSORTIUM, LLC]3
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48FEXOFENADINE HCL TABLET [CHAIN DRUG CONSORTIUM, LLC]3
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675FEXOFENADINE HCL TABLET [CHAIN DRUG CONSORTIUM, LLC]3
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTFEXOFENADINE HCL TABLET [CHAIN DRUG CONSORTIUM, LLC]3
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOFEXOFENADINE HCL TABLET [CHAIN DRUG CONSORTIUM, LLC]3
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XFEXOFENADINE HCL TABLET [CHAIN DRUG CONSORTIUM, LLC]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30FEXOFENADINE HCL TABLET [CHAIN DRUG CONSORTIUM, LLC]3
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AFEXOFENADINE HCL TABLET [CHAIN DRUG CONSORTIUM, LLC]3
POVIDONESINACTIVE INGREDIENTFZ989GH94EFEXOFENADINE HCL TABLET [CHAIN DRUG CONSORTIUM, LLC]3
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4FEXOFENADINE HCL TABLET [CHAIN DRUG CONSORTIUM, LLC]3
TALCINACTIVE INGREDIENT7SEV7J4R1UFEXOFENADINE HCL TABLET [CHAIN DRUG CONSORTIUM, LLC]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPFEXOFENADINE HCL TABLET [CHAIN DRUG CONSORTIUM, LLC]3