Home NDC 69230-300 Fexofenadine HCL
Product NDC 69230-300
11-digit product format 692300300
Labeler code 69230
Product ID 69230-300_eb46135f-d536-4328-96dc-30a2b16fe9d2
Type HUMAN OTC DRUG
Nonproprietary name Fexofenadine HCL
Dosage form TABLET
Route ORAL
Labeler Camber Consumer Care
Application ANDA204097
Marketing category ANDA
Marketing start 2016-08-19
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 NDC auxiliary status# These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.
Current NDC status page 1 of 1 · 2 matching rows.
Dataset, Scope, Product NDC table Dataset Scope Product NDC Package NDC Code Status Reporting period Source date unfinished product product 69230-300 UNFINISHED Active or certified unfinished drug listing 2026-10-16 unfinished package package 69230-300 69230-300-00 UNFINISHED Active or certified unfinished drug listing 2026-10-16
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 · 15 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 21:27 UTC · source 2025-12-05 unfinished product product a6255e0c9aa5…a0211a219f2e…2025-12-14 21:27 UTC · source 2025-12-05 unfinished package package 69230-300-00 a6255e0c9aa5…a0211a219f2e…2025-08-26 23:59 UTC · source 2025-08-26 unfinished product product 1d862106b807…00c93037cd84…2025-08-26 23:59 UTC · source 2025-08-26 unfinished package package 69230-300-00 1d862106b807…00c93037cd84…2025-05-15 14:59 UTC · source 2025-05-14 unfinished product product 390b4c401c3f…2c692c2daee3…2025-05-15 14:59 UTC · source 2025-05-14 unfinished package package 69230-300-00 390b4c401c3f…2c692c2daee3…2025-04-01 07:37 UTC · source 2025-03-31 unfinished product product e30019b0c005…a3f0b14938b7…2025-04-01 07:37 UTC · source 2025-03-31 unfinished package package 69230-300-00 e30019b0c005…a3f0b14938b7…2025-03-01 13:19 UTC · source 2025-02-28 unfinished product product bbbc9f937eca…946b9c97cf81…2025-03-01 13:19 UTC · source 2025-02-28 unfinished package package 69230-300-00 bbbc9f937eca…946b9c97cf81…2025-02-27 05:24 UTC · source 2025-02-26 unfinished product product f268b84574a6…26285f5ac5df…2025-02-27 05:24 UTC · source 2025-02-26 unfinished package package 69230-300-00 f268b84574a6…26285f5ac5df…2025-02-01 13:13 UTC · source 2025-01-31 unfinished product product f764e8902f78…92046438deef…2025-02-01 13:13 UTC · source 2025-01-31 unfinished package package 69230-300-00 f764e8902f78…92046438deef…2025-01-20 13:05 UTC · source 2025-01-17 unfinished package package 69230-300-00 68b1e3bced9e…98a755eb8bc6…
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.
Additional Listing Data#
Finished product Yes
Brand name base Fexofenadine HCL
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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 997420 Internal RxNorm lookup 997501 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 69230-300-01 Fexofenadine HCL 1 in 1 CARTON TABLET 1 3 69230-300-01 Fexofenadine HCL 100 in 1 BOTTLE TABLET 100 3 69230-300-05 Fexofenadine HCL 500 in 1 BOTTLE TABLET 500 3 69230-300-30 Fexofenadine HCL 30 in 1 BOTTLE TABLET 30 3 69230-300-30 Fexofenadine HCL 1 in 1 CARTON TABLET 1 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 69230-300 FEXOFENADINE HCL TABLET [CAMBER CONSUMER CARE] 3 Current NDC, Legacy NDC, 5 package rows 20190530_e437655c-f1f3-4b58-89ba-bf22e416d311.zip
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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 69230-300-00 69230030000 3 BAG in 1 DRUM (69230-300-00) / 10000 TABLET in 1 BAG 3 bag 19-AUG-16 Current 69230-300-01 69230030001 1 BOTTLE in 1 CARTON (69230-300-01) / 100 TABLET in 1 BOTTLE 1 bottle 2016-08-19 0000-00-00 No No Current 69230-300-05 69230030005 500 TABLET in 1 BOTTLE (69230-300-05) 500 tablet 2016-08-19 0000-00-00 No No Current 69230-300-30 69230030030 1 BOTTLE in 1 CARTON (69230-300-30) / 30 TABLET in 1 BOTTLE 1 bottle 2016-08-19 0000-00-00 No No Current