Home NDC 85786-204 Fexofenadine HCl 180 mg
Product NDC 85786-204
11-digit product format 857860204
Labeler code 85786
Product ID 85786-204_4ef8be57-98e8-20a9-e063-6394a90ab779
Type HUMAN OTC DRUG
Nonproprietary name Fexofenadine HCl
Dosage form TABLET
Route ORAL
Labeler Farmacias De Similares TX LLC
Application ANDA211075
Marketing category ANDA
Marketing start 2026-04-08
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 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A211075-001 FEXOFENADINE HYDROCHLORIDE ALLERGY FEXOFENADINE HYDROCHLORIDE 60MG TABLET / ORAL 2019-10-18 A211075-002 FEXOFENADINE HYDROCHLORIDE ALLERGY FEXOFENADINE HYDROCHLORIDE 180MG TABLET / ORAL 2019-10-18
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 A211075-001 FEXOFENADINE HYDROCHLORIDE ALLERGY 60MG TABLET / ORAL 2019-10-18 a50c72e98297…2026-08-01 22:54:32 2026-06 A211075-002 FEXOFENADINE HYDROCHLORIDE ALLERGY 180MG TABLET / ORAL 2019-10-18 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 3 · 57 matching rows.
Additional Listing Data#
Finished product Yes
Brand name base Fexofenadine HCl 180 mg
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength FEXOFENADINE HYDROCHLORIDE 180 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2S068B75ZU Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 997420 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 85786-204-30 Fexofenadine HCl 180 mg 30 in 1 BOTTLE, PLASTIC TABLET 30 2 85786-204-30 Fexofenadine HCl 180 mg 1 in 1 CARTON TABLET 1 2
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 85786-204-30 85786020430 1 BOTTLE, PLASTIC in 1 CARTON (85786-204-30) / 30 TABLET in 1 BOTTLE, PLASTIC 2026-04-08 No No Current