Home NDC 58602-710-40 Fexofenadine hydrochloride
Product NDC 58602-710
Requested package NDC 58602-710-40
11-digit product format 586020710
Labeler code 58602
Product ID 58602-710_89f401d2-5303-4773-93b9-ef63772ce9dc
Type HUMAN OTC DRUG
Nonproprietary name Fexofenadine hydrochloride
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Aurohealth LLC
Application ANDA202039
Marketing category ANDA
Marketing start 2016-10-05
Marketing end 0000-00-00
Substance FEXOFENADINE HYDROCHLORIDE
Active strength 60 mg/1
NDC exclude flag No
Listing certified through 2020-12-31
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.
Product history page 1 of 3 · 99 observed 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 2024-11-08 22:44 UTC · 2 captures of this ZIP 2024-11 A202039-001 CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY 30MG TABLET / ORAL 2014-11-19 d8e5a09893c0…2024-11-08 22:44 UTC · 2 captures of this ZIP 2024-11 A202039-002 FEXOFENADINE HYDROCHLORIDE ALLERGY 60MG TABLET / ORAL 2014-11-19 d8e5a09893c0…2024-11-08 22:44 UTC · 2 captures of this ZIP 2024-11 A202039-003 FEXOFENADINE HYDROCHLORIDE ALLERGY 180MG TABLET / ORAL 2014-11-19 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A202039-001 CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY 30MG TABLET / ORAL 2014-11-19 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A202039-002 FEXOFENADINE HYDROCHLORIDE ALLERGY 60MG TABLET / ORAL 2014-11-19 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A202039-003 FEXOFENADINE HYDROCHLORIDE ALLERGY 180MG TABLET / ORAL 2014-11-19 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A202039-001 CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY 30MG TABLET / ORAL 2014-11-19 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A202039-002 FEXOFENADINE HYDROCHLORIDE ALLERGY 60MG TABLET / ORAL 2014-11-19 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A202039-003 FEXOFENADINE HYDROCHLORIDE ALLERGY 180MG TABLET / ORAL 2014-11-19 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A202039-001 CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY 30MG TABLET / ORAL 2014-11-19 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A202039-002 FEXOFENADINE HYDROCHLORIDE ALLERGY 60MG TABLET / ORAL 2014-11-19 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A202039-003 FEXOFENADINE HYDROCHLORIDE ALLERGY 180MG TABLET / ORAL 2014-11-19 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A202039-001 CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY 30MG TABLET / ORAL 2014-11-19 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A202039-002 FEXOFENADINE HYDROCHLORIDE ALLERGY 60MG TABLET / ORAL 2014-11-19 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A202039-003 FEXOFENADINE HYDROCHLORIDE ALLERGY 180MG TABLET / ORAL 2014-11-19 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A202039-001 CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY 30MG TABLET / ORAL 2014-11-19 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A202039-002 FEXOFENADINE HYDROCHLORIDE ALLERGY 60MG TABLET / ORAL 2014-11-19 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A202039-003 FEXOFENADINE HYDROCHLORIDE ALLERGY 180MG TABLET / ORAL 2014-11-19 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A202039-001 CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY 30MG TABLET / ORAL 2014-11-19 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A202039-002 FEXOFENADINE HYDROCHLORIDE ALLERGY 60MG TABLET / ORAL 2014-11-19 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A202039-003 FEXOFENADINE HYDROCHLORIDE ALLERGY 180MG TABLET / ORAL 2014-11-19 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A202039-001 CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY 30MG TABLET / ORAL 2014-11-19 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A202039-002 FEXOFENADINE HYDROCHLORIDE ALLERGY 60MG TABLET / ORAL 2014-11-19 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A202039-003 FEXOFENADINE HYDROCHLORIDE ALLERGY 180MG TABLET / ORAL 2014-11-19 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A202039-001 CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY 30MG TABLET / ORAL 2014-11-19 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A202039-002 FEXOFENADINE HYDROCHLORIDE ALLERGY 60MG TABLET / ORAL 2014-11-19 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A202039-003 FEXOFENADINE HYDROCHLORIDE ALLERGY 180MG TABLET / ORAL 2014-11-19 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A202039-001 CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY 30MG TABLET / ORAL 2014-11-19 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A202039-002 FEXOFENADINE HYDROCHLORIDE ALLERGY 60MG TABLET / ORAL 2014-11-19 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A202039-003 FEXOFENADINE HYDROCHLORIDE ALLERGY 180MG TABLET / ORAL 2014-11-19 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A202039-001 CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY 30MG TABLET / ORAL 2014-11-19 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A202039-002 FEXOFENADINE HYDROCHLORIDE ALLERGY 60MG TABLET / ORAL 2014-11-19 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A202039-003 FEXOFENADINE HYDROCHLORIDE ALLERGY 180MG TABLET / ORAL 2014-11-19 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A202039-001 CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY 30MG TABLET / ORAL 2014-11-19 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A202039-002 FEXOFENADINE HYDROCHLORIDE ALLERGY 60MG TABLET / ORAL 2014-11-19 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A202039-003 FEXOFENADINE HYDROCHLORIDE ALLERGY 180MG TABLET / ORAL 2014-11-19 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A202039-001 CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY 30MG TABLET / ORAL 2014-11-19 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A202039-002 FEXOFENADINE HYDROCHLORIDE ALLERGY 60MG TABLET / ORAL 2014-11-19 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A202039-003 FEXOFENADINE HYDROCHLORIDE ALLERGY 180MG TABLET / ORAL 2014-11-19 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A202039-001 CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY 30MG TABLET / ORAL 2014-11-19 5aa47cf7b7d7…
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.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 58602-710-40 Fexofenadine hydrochloride 1 in 1 CARTON TABLET, FILM COATED 1 5 58602-710-75 Fexofenadine hydrochloride 1 in 1 CARTON TABLET, FILM COATED 1 5
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 [AUROHEALTH LLC] 1 FEXOFENADINE ACTIVE MOIETY E6582LOH6V FEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [AUROHEALTH LLC] 1 ANHYDROUS LACTOSE INACTIVE INGREDIENT 3SY5LH9PMK FEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [AUROHEALTH LLC] 1 COLLOIDAL SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 FEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [AUROHEALTH LLC] 1 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 FEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [AUROHEALTH LLC] 1 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 FEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [AUROHEALTH LLC] 1 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT FEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [AUROHEALTH LLC] 1 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO FEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [AUROHEALTH LLC] 1 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X FEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [AUROHEALTH LLC] 1 POLYETHYLENE GLYCOL 400 INACTIVE INGREDIENT B697894SGQ FEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [AUROHEALTH LLC] 1 STARCH, PREGELATINIZED CORN INACTIVE INGREDIENT O8232NY3SJ FEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [AUROHEALTH LLC] 1 STEARIC ACID INACTIVE INGREDIENT 4ELV7Z65AP FEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [AUROHEALTH LLC] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP FEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [AUROHEALTH LLC] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 58602-710 FEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [AUROHEALTH LLC] 5 Legacy NDC, 2 package rows 20190911_a02e680f-60f3-41cc-91df-0fcd76fe36f6.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 58602-710-40 58602071040 1 TABLET, FILM COATED in 1 CARTON (58602-710-40) 2016-10-05 0000-00-00 No No Current