FDA.reportPublic FDA data

Fexofenadine Hydrochloride

Product NDC
70518-0746
11-digit product format
705180746
Labeler code
70518
Product ID
70518-0746_8e7aeb62-b16a-22cf-e053-2a95a90ac71e
Type
HUMAN OTC DRUG
Nonproprietary name
fexofenadine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA077081
Marketing category
ANDA
Marketing start
2017-09-25
Marketing end
0000-00-00
Substance
FEXOFENADINE HYDROCHLORIDE
Active strength
180 mg/1
NDC exclude flag
No
Listing certified through
2020-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct70518-0746DDiscontinued by firm2026-07-31
excluded packagepackage70518-074670518-0746-0DDiscontinued 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 · 9 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A077081-001FEXOFENADINE HYDROCHLORIDEFEXOFENADINE HYDROCHLORIDE180MGTABLET / ORAL2007-04-16
A077081-002FEXOFENADINE HYDROCHLORIDEFEXOFENADINE HYDROCHLORIDE30MGTABLET / ORAL2008-04-11
A077081-003FEXOFENADINE HYDROCHLORIDEFEXOFENADINE HYDROCHLORIDE60MGTABLET / ORAL2008-04-11
A077081-004CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGYFEXOFENADINE HYDROCHLORIDE30MGTABLET / ORAL2011-07-21
A077081-005CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVESFEXOFENADINE HYDROCHLORIDE30MGTABLET / ORAL2011-07-21
A077081-006FEXOFENADINE HYDROCHLORIDE ALLERGYFEXOFENADINE HYDROCHLORIDE60MGTABLET / ORAL2011-07-21
A077081-007FEXOFENADINE HYDROCHLORIDE HIVESFEXOFENADINE HYDROCHLORIDE60MGTABLET / ORAL2011-07-21
A077081-008FEXOFENADINE HYDROCHLORIDE ALLERGYFEXOFENADINE HYDROCHLORIDE180MGTABLET / ORAL2011-07-21
A077081-009FEXOFENADINE HYDROCHLORIDE HIVESFEXOFENADINE HYDROCHLORIDE180MGTABLET / ORAL2011-07-21

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 22:54:322026-06A077081-001FEXOFENADINE HYDROCHLORIDE180MGTABLET / ORAL2007-04-16a50c72e98297…
2026-08-01 22:54:322026-06A077081-002FEXOFENADINE HYDROCHLORIDE30MGTABLET / ORAL2008-04-11a50c72e98297…
2026-08-01 22:54:322026-06A077081-003FEXOFENADINE HYDROCHLORIDE60MGTABLET / ORAL2008-04-11a50c72e98297…
2026-08-01 22:54:322026-06A077081-004CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY30MGTABLET / ORAL2011-07-21a50c72e98297…
2026-08-01 22:54:322026-06A077081-005CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES30MGTABLET / ORAL2011-07-21a50c72e98297…
2026-08-01 22:54:322026-06A077081-006FEXOFENADINE HYDROCHLORIDE ALLERGY60MGTABLET / ORAL2011-07-21a50c72e98297…
2026-08-01 22:54:322026-06A077081-007FEXOFENADINE HYDROCHLORIDE HIVES60MGTABLET / ORAL2011-07-21a50c72e98297…
2026-08-01 22:54:322026-06A077081-008FEXOFENADINE HYDROCHLORIDE ALLERGY180MGTABLET / ORAL2011-07-21a50c72e98297…
2026-08-01 22:54:322026-06A077081-009FEXOFENADINE HYDROCHLORIDE HIVES180MGTABLET / ORAL2011-07-21a50c72e98297…