Home NDC 70934-610 Fexofenadine HCL
Product NDC 70934-610
11-digit product format 709340610
Labeler code 70934
Product ID 70934-610_ab70dee6-4c46-cb14-e053-2a95a90adf5d
Type HUMAN OTC DRUG
Nonproprietary name Fexofenadine HCL
Dosage form TABLET
Route ORAL
Labeler Denton Pharma, Inc. dba Northwind Pharmaceuticals
Application ANDA204097
Marketing category ANDA
Marketing start 2020-03-13
Marketing end 0000-00-00
Substance FEXOFENADINE HYDROCHLORIDE
Active strength 180 mg/1
NDC exclude flag No
Listing certified through 2021-12-31
Current FDA listing Historical FDA.report record
Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 36 matching rows.
View current auxiliary records. · View the auxiliary file history.
Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
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 A204097-001 CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY FEXOFENADINE HYDROCHLORIDE 30MG TABLET / ORAL 2016-08-19 A204097-002 FEXOFENADINE HYDROCHLORIDE ALLERGY FEXOFENADINE HYDROCHLORIDE 60MG TABLET / ORAL 2016-08-19 A204097-003 FEXOFENADINE HYDROCHLORIDE ALLERGY FEXOFENADINE HYDROCHLORIDE 180MG TABLET / ORAL 2016-08-19
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 4 · 132 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 2026-10-15 13:18:30 2026-09 A204097-001 CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY 30MG TABLET / ORAL 2016-08-19 c2088c7a36db…2026-10-15 13:18:30 2026-09 A204097-002 FEXOFENADINE HYDROCHLORIDE ALLERGY 60MG TABLET / ORAL 2016-08-19 c2088c7a36db…2026-10-15 13:18:30 2026-09 A204097-003 FEXOFENADINE HYDROCHLORIDE ALLERGY 180MG TABLET / ORAL 2016-08-19 c2088c7a36db…2026-09-14 22:38:34 2026-08 A204097-001 CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY 30MG TABLET / ORAL 2016-08-19 84e616aacf4f…2026-09-14 22:38:34 2026-08 A204097-002 FEXOFENADINE HYDROCHLORIDE ALLERGY 60MG TABLET / ORAL 2016-08-19 84e616aacf4f…2026-09-14 22:38:34 2026-08 A204097-003 FEXOFENADINE HYDROCHLORIDE ALLERGY 180MG TABLET / ORAL 2016-08-19 84e616aacf4f…2026-08-18 06:07:40 2026-07 A204097-001 CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY 30MG TABLET / ORAL 2016-08-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A204097-002 FEXOFENADINE HYDROCHLORIDE ALLERGY 60MG TABLET / ORAL 2016-08-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A204097-003 FEXOFENADINE HYDROCHLORIDE ALLERGY 180MG TABLET / ORAL 2016-08-19 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A204097-001 CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY 30MG TABLET / ORAL 2016-08-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A204097-002 FEXOFENADINE HYDROCHLORIDE ALLERGY 60MG TABLET / ORAL 2016-08-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A204097-003 FEXOFENADINE HYDROCHLORIDE ALLERGY 180MG TABLET / ORAL 2016-08-19 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A204097-001 CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY 30MG TABLET / ORAL 2016-08-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A204097-002 FEXOFENADINE HYDROCHLORIDE ALLERGY 60MG TABLET / ORAL 2016-08-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A204097-003 FEXOFENADINE HYDROCHLORIDE ALLERGY 180MG TABLET / ORAL 2016-08-19 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A204097-001 CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY 30MG TABLET / ORAL 2016-08-19 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A204097-002 FEXOFENADINE HYDROCHLORIDE ALLERGY 60MG TABLET / ORAL 2016-08-19 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A204097-003 FEXOFENADINE HYDROCHLORIDE ALLERGY 180MG TABLET / ORAL 2016-08-19 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A204097-001 CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY 30MG TABLET / ORAL 2016-08-19 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A204097-002 FEXOFENADINE HYDROCHLORIDE ALLERGY 60MG TABLET / ORAL 2016-08-19 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A204097-003 FEXOFENADINE HYDROCHLORIDE ALLERGY 180MG TABLET / ORAL 2016-08-19 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A204097-001 CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY 30MG TABLET / ORAL 2016-08-19 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A204097-002 FEXOFENADINE HYDROCHLORIDE ALLERGY 60MG TABLET / ORAL 2016-08-19 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A204097-003 FEXOFENADINE HYDROCHLORIDE ALLERGY 180MG TABLET / ORAL 2016-08-19 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A204097-001 CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY 30MG TABLET / ORAL 2016-08-19 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A204097-002 FEXOFENADINE HYDROCHLORIDE ALLERGY 60MG TABLET / ORAL 2016-08-19 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A204097-003 FEXOFENADINE HYDROCHLORIDE ALLERGY 180MG TABLET / ORAL 2016-08-19 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A204097-001 CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY 30MG TABLET / ORAL 2016-08-19 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A204097-002 FEXOFENADINE HYDROCHLORIDE ALLERGY 60MG TABLET / ORAL 2016-08-19 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A204097-003 FEXOFENADINE HYDROCHLORIDE ALLERGY 180MG TABLET / ORAL 2016-08-19 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A204097-001 CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY 30MG TABLET / ORAL 2016-08-19 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A204097-002 FEXOFENADINE HYDROCHLORIDE ALLERGY 60MG TABLET / ORAL 2016-08-19 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A204097-003 FEXOFENADINE HYDROCHLORIDE ALLERGY 180MG TABLET / ORAL 2016-08-19 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A204097-001 CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY 30MG TABLET / ORAL 2016-08-19 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A204097-002 FEXOFENADINE HYDROCHLORIDE ALLERGY 60MG TABLET / ORAL 2016-08-19 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A204097-003 FEXOFENADINE HYDROCHLORIDE ALLERGY 180MG TABLET / ORAL 2016-08-19 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A204097-001 CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY 30MG TABLET / ORAL 2016-08-19 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A204097-002 FEXOFENADINE HYDROCHLORIDE ALLERGY 60MG TABLET / ORAL 2016-08-19 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A204097-003 FEXOFENADINE HYDROCHLORIDE ALLERGY 180MG TABLET / ORAL 2016-08-19 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A204097-001 CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY 30MG TABLET / ORAL 2016-08-19 79d66fd596c7…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 20 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 70934-610-30 70934061030 30 TABLET in 1 BOTTLE, PLASTIC (70934-610-30) 30 tablet 2020-03-13 0000-00-00 No No Current 70934-610-90 70934061090 90 TABLET in 1 BOTTLE, PLASTIC (70934-610-90) 90 tablet 2020-04-16 0000-00-00 No No Current