Home NDC 13107-066 Fexofenadine hydrochloride
Product NDC 13107-066
11-digit product format 131070066
Labeler code 13107
Product ID 13107-066_536dab2f-7586-4d45-b745-99c6cab47743
Type HUMAN OTC DRUG
Nonproprietary name Fexofenadine hydrochloride
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Aurolife Pharma, LLC
Application ANDA202039
Marketing category ANDA
Marketing start 2015-08-26
Marketing end 0000-00-00
Substance FEXOFENADINE HYDROCHLORIDE
Active strength 60 mg/1
NDC exclude flag E
Listing certified through 2018-12-31
Current FDA listing Historical FDA.report record Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A202039-001 CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY FEXOFENADINE HYDROCHLORIDE 30MG TABLET / ORAL 2014-11-19 A202039-002 FEXOFENADINE HYDROCHLORIDE ALLERGY FEXOFENADINE HYDROCHLORIDE 60MG TABLET / ORAL 2014-11-19 A202039-003 FEXOFENADINE HYDROCHLORIDE ALLERGY FEXOFENADINE HYDROCHLORIDE 180MG TABLET / ORAL 2014-11-19
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-01 22:54:32 2026-06 A202039-001 CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY 30MG TABLET / ORAL 2014-11-19 a50c72e98297…2026-08-01 22:54:32 2026-06 A202039-002 FEXOFENADINE HYDROCHLORIDE ALLERGY 60MG TABLET / ORAL 2014-11-19 a50c72e98297…2026-08-01 22:54:32 2026-06 A202039-003 FEXOFENADINE HYDROCHLORIDE ALLERGY 180MG TABLET / ORAL 2014-11-19 a50c72e98297…
openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
FDA-Initiated Inactive NDC Indexing# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded FEXOFENADINE HYDROCHLORIDE ACTIVE INGREDIENT 2S068B75ZU FEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [AVKARE, INC.] 2 FEXOFENADINE HYDROCHLORIDE ACTIVE INGREDIENT 2S068B75ZU FEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [AUROLIFE PHARMA, LLC] 2 FEXOFENADINE ACTIVE MOIETY E6582LOH6V FEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [AUROLIFE PHARMA, LLC] 2 FEXOFENADINE ACTIVE MOIETY E6582LOH6V FEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [AVKARE, INC.] 2 ANHYDROUS LACTOSE INACTIVE INGREDIENT 3SY5LH9PMK FEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [AVKARE, INC.] 2 ANHYDROUS LACTOSE INACTIVE INGREDIENT 3SY5LH9PMK FEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [AUROLIFE PHARMA, LLC] 2 COLLOIDAL SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 FEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [AVKARE, INC.] 2 COLLOIDAL SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 FEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [AUROLIFE PHARMA, LLC] 2 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 FEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [AVKARE, INC.] 2 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 FEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [AUROLIFE PHARMA, LLC] 2 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 FEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [AUROLIFE PHARMA, LLC] 2 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 FEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [AVKARE, INC.] 2 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT FEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [AVKARE, INC.] 2 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT FEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [AUROLIFE PHARMA, LLC] 2 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO FEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [AVKARE, INC.] 2 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO FEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [AUROLIFE PHARMA, LLC] 2 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X FEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [AVKARE, INC.] 2 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X FEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [AUROLIFE PHARMA, LLC] 2 POLYETHYLENE GLYCOL 400 INACTIVE INGREDIENT B697894SGQ FEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [AVKARE, INC.] 2 POLYETHYLENE GLYCOL 400 INACTIVE INGREDIENT B697894SGQ FEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [AUROLIFE PHARMA, LLC] 2 STARCH, PREGELATINIZED CORN INACTIVE INGREDIENT O8232NY3SJ FEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [AVKARE, INC.] 2 STARCH, PREGELATINIZED CORN INACTIVE INGREDIENT O8232NY3SJ FEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [AUROLIFE PHARMA, LLC] 2 STEARIC ACID INACTIVE INGREDIENT 4ELV7Z65AP FEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [AVKARE, INC.] 2 STEARIC ACID INACTIVE INGREDIENT 4ELV7Z65AP FEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [AUROLIFE PHARMA, LLC] 2 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP FEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [AUROLIFE PHARMA, LLC] 2 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP FEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [AVKARE, INC.] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 13107-066 FEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [AUROLIFE PHARMA, LLC] 2 Legacy NDC 20150829_bc176016-ebab-4430-82ac-dde96b545194.zip