Home NDC 62207-623 Fexofenadine Hydrochloride
Product NDC 62207-623
11-digit product format 622070623
Labeler code 62207
Product ID 62207-623_1d43d4d6-9021-eac7-e063-6294a90ad21a
Type HUMAN OTC DRUG
Nonproprietary name Fexofenadine Hydrochloride
Dosage form TABLET
Route ORAL
Labeler Granules India Limited
Application ANDA211075
Marketing category ANDA
Marketing start 2024-01-02
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 2026-12-31
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 62207-623 UNFINISHED Active or certified unfinished drug listing 2026-08-17 unfinished package package 62207-623 62207-623-97 UNFINISHED Active or certified unfinished drug listing 2026-08-17
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 · 28 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 62207-623-97 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 62207-623-97 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 62207-623-97 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 62207-623-97 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 62207-623-97 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 62207-623-97 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 62207-623-97 f764e8902f78…92046438deef…2025-01-20 13:05 UTC · source 2025-01-17 unfinished product product 68b1e3bced9e…98a755eb8bc6…2025-01-20 13:05 UTC · source 2025-01-17 unfinished package package 62207-623-97 68b1e3bced9e…98a755eb8bc6…2024-11-29 20:42 UTC · source 2024-11-29 unfinished product product 05c55d027831…ca05dca9dc4c…2024-11-29 20:42 UTC · source 2024-11-29 unfinished package package 62207-623-97 05c55d027831…ca05dca9dc4c…2024-11-09 02:36 UTC · source 2024-11-08 unfinished product product 48b4f40e6753…c7c7a00d2afa…2024-11-09 02:36 UTC · source 2024-11-08 unfinished package package 62207-623-97 48b4f40e6753…c7c7a00d2afa…2024-10-09 02:27 UTC · source 2024-10-08 unfinished product product 27f29a85d7e4…1372111e901f…2024-10-09 02:27 UTC · source 2024-10-08 unfinished package package 62207-623-97 27f29a85d7e4…1372111e901f…2024-07-10 04:00 UTC · source 2024-07-09 unfinished product product 8d62ce987f31…9fe9ef23e30d…2024-07-10 04:00 UTC · source 2024-07-09 unfinished package package 62207-623-97 8d62ce987f31…9fe9ef23e30d…2024-05-28 21:11 UTC · source 2024-05-28 unfinished product product d1e113ab4d42…063ee3eb0a1d…2024-05-28 21:11 UTC · source 2024-05-28 unfinished package package 62207-623-97 d1e113ab4d42…063ee3eb0a1d…2024-05-15 03:51 UTC · source 2024-05-14 unfinished product product 50b4072663b7…eae3003ed65e…2024-05-15 03:51 UTC · source 2024-05-14 unfinished package package 62207-623-97 50b4072663b7…eae3003ed65e…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
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.
Product history page 1 of 2 · 80 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 2026-08-18 06:07:40 2026-07 A211075-001 FEXOFENADINE HYDROCHLORIDE ALLERGY 60MG TABLET / ORAL 2019-10-18 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A211075-002 FEXOFENADINE HYDROCHLORIDE ALLERGY 180MG TABLET / ORAL 2019-10-18 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A211075-001 FEXOFENADINE HYDROCHLORIDE ALLERGY 60MG TABLET / ORAL 2019-10-18 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A211075-002 FEXOFENADINE HYDROCHLORIDE ALLERGY 180MG TABLET / ORAL 2019-10-18 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211075-001 FEXOFENADINE HYDROCHLORIDE ALLERGY 60MG TABLET / ORAL 2019-10-18 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211075-002 FEXOFENADINE HYDROCHLORIDE ALLERGY 180MG TABLET / ORAL 2019-10-18 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A211075-001 FEXOFENADINE HYDROCHLORIDE ALLERGY 60MG TABLET / ORAL 2019-10-18 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A211075-002 FEXOFENADINE HYDROCHLORIDE ALLERGY 180MG TABLET / ORAL 2019-10-18 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211075-001 FEXOFENADINE HYDROCHLORIDE ALLERGY 60MG TABLET / ORAL 2019-10-18 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211075-002 FEXOFENADINE HYDROCHLORIDE ALLERGY 180MG TABLET / ORAL 2019-10-18 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A211075-001 FEXOFENADINE HYDROCHLORIDE ALLERGY 60MG TABLET / ORAL 2019-10-18 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A211075-002 FEXOFENADINE HYDROCHLORIDE ALLERGY 180MG TABLET / ORAL 2019-10-18 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A211075-001 FEXOFENADINE HYDROCHLORIDE ALLERGY 60MG TABLET / ORAL 2019-10-18 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A211075-002 FEXOFENADINE HYDROCHLORIDE ALLERGY 180MG TABLET / ORAL 2019-10-18 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A211075-001 FEXOFENADINE HYDROCHLORIDE ALLERGY 60MG TABLET / ORAL 2019-10-18 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A211075-002 FEXOFENADINE HYDROCHLORIDE ALLERGY 180MG TABLET / ORAL 2019-10-18 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A211075-001 FEXOFENADINE HYDROCHLORIDE ALLERGY 60MG TABLET / ORAL 2019-10-18 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A211075-002 FEXOFENADINE HYDROCHLORIDE ALLERGY 180MG TABLET / ORAL 2019-10-18 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A211075-001 FEXOFENADINE HYDROCHLORIDE ALLERGY 60MG TABLET / ORAL 2019-10-18 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A211075-002 FEXOFENADINE HYDROCHLORIDE ALLERGY 180MG TABLET / ORAL 2019-10-18 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A211075-001 FEXOFENADINE HYDROCHLORIDE ALLERGY 60MG TABLET / ORAL 2019-10-18 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A211075-002 FEXOFENADINE HYDROCHLORIDE ALLERGY 180MG TABLET / ORAL 2019-10-18 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A211075-001 FEXOFENADINE HYDROCHLORIDE ALLERGY 60MG TABLET / ORAL 2019-10-18 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A211075-002 FEXOFENADINE HYDROCHLORIDE ALLERGY 180MG TABLET / ORAL 2019-10-18 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A211075-001 FEXOFENADINE HYDROCHLORIDE ALLERGY 60MG TABLET / ORAL 2019-10-18 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A211075-002 FEXOFENADINE HYDROCHLORIDE ALLERGY 180MG TABLET / ORAL 2019-10-18 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A211075-001 FEXOFENADINE HYDROCHLORIDE ALLERGY 60MG TABLET / ORAL 2019-10-18 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A211075-002 FEXOFENADINE HYDROCHLORIDE ALLERGY 180MG TABLET / ORAL 2019-10-18 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A211075-001 FEXOFENADINE HYDROCHLORIDE ALLERGY 60MG TABLET / ORAL 2019-10-18 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A211075-002 FEXOFENADINE HYDROCHLORIDE ALLERGY 180MG TABLET / ORAL 2019-10-18 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A211075-001 FEXOFENADINE HYDROCHLORIDE ALLERGY 60MG TABLET / ORAL 2019-10-18 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A211075-002 FEXOFENADINE HYDROCHLORIDE ALLERGY 180MG TABLET / ORAL 2019-10-18 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A211075-001 FEXOFENADINE HYDROCHLORIDE ALLERGY 60MG TABLET / ORAL 2019-10-18 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A211075-002 FEXOFENADINE HYDROCHLORIDE ALLERGY 180MG TABLET / ORAL 2019-10-18 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A211075-001 FEXOFENADINE HYDROCHLORIDE ALLERGY 60MG TABLET / ORAL 2019-10-18 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A211075-002 FEXOFENADINE HYDROCHLORIDE ALLERGY 180MG TABLET / ORAL 2019-10-18 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A211075-001 FEXOFENADINE HYDROCHLORIDE ALLERGY 60MG TABLET / ORAL 2019-10-18 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A211075-002 FEXOFENADINE HYDROCHLORIDE ALLERGY 180MG TABLET / ORAL 2019-10-18 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A211075-001 FEXOFENADINE HYDROCHLORIDE ALLERGY 60MG TABLET / ORAL 2019-10-18 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A211075-002 FEXOFENADINE HYDROCHLORIDE ALLERGY 180MG TABLET / ORAL 2019-10-18 bb7c543d1eb4…
Additional Listing Data#
Finished product Yes
Brand name base Fexofenadine Hydrochloride
Listing expiration 2026-12-31 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 62207-623-41 Fexofenadine Hydrochloride 24 in 1 CONTAINER TABLET 24 1 62207-623-45 Fexofenadine Hydrochloride 225 in 1 CONTAINER TABLET 225 1 62207-623-57 Fexofenadine Hydrochloride 90 in 1 CONTAINER TABLET 90 1 62207-623-71 Fexofenadine Hydrochloride 7 in 1 CARTON TABLET 7 1 62207-623-71 Fexofenadine Hydrochloride 10 in 1 BLISTER PACK TABLET 10 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 62207-623 FEXOFENADINE HYDROCHLORIDE TABLET [GRANULES INDIA LIMITED] 1 Current NDC, 5 package rows 20240810_1d46555d-827b-b154-e063-6294a90ad3d5.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 3 · 58 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 62207-623-41 62207062341 24 TABLET in 1 CONTAINER (62207-623-41) 24 tablet 2024-01-02 No No Current 62207-623-45 62207062345 225 TABLET in 1 CONTAINER (62207-623-45) 225 tablet 2024-01-02 No No Current 62207-623-57 62207062357 90 TABLET in 1 CONTAINER (62207-623-57) 90 tablet 2024-01-02 No No Current 62207-623-71 62207062371 7 BLISTER PACK in 1 CARTON (62207-623-71) / 10 TABLET in 1 BLISTER PACK 7 blister pack 2024-01-02 No No Current 62207-623-97 62207062397 40000 TABLET in 1 DRUM (62207-623-97) 40000 tablet 27-NOV-23 Current