Home NDC 62207-623-97 Fexofenadine Hydrochloride
Product NDC 62207-623
Requested package NDC 62207-623-97
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 Observed NDC auxiliary status history# Observed captured status history: Rows come only from successfully parsed FDA auxiliary ZIP captures. They show the state present in that artifact, not a continuous regulatory timeline. Absence before, after, or between captures is not proof of status, and a known non-data HTTP 403 capture is preserved in backfill provenance but cannot produce a status row.
Historic NDC status page 1 of 1 · 14 matching rows.
Browse every current auxiliary row. · Browse the complete NDC auxiliary source catalog.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2025-12-14 21:27 UTC · source 2025-12-05 unfinished package package 62207-623 62207-623-97 UNFINISHED Active or certified unfinished drug listing unfinished / ndc_unfinished.zip a6255e0c9aa5…a0211a219f2e…2025-08-26 23:59 UTC · source 2025-08-26 unfinished package package 62207-623 62207-623-97 UNFINISHED Active or certified unfinished drug listing unfinished / ndc_unfinished.zip 1d862106b807…00c93037cd84…2025-05-15 14:59 UTC · source 2025-05-14 unfinished package package 62207-623 62207-623-97 UNFINISHED Active or certified unfinished drug listing unfinished / ndc_unfinished.zip 390b4c401c3f…2c692c2daee3…2025-04-01 07:37 UTC · source 2025-03-31 unfinished package package 62207-623 62207-623-97 UNFINISHED Active or certified unfinished drug listing unfinished / ndc_unfinished.zip e30019b0c005…a3f0b14938b7…2025-03-01 13:19 UTC · source 2025-02-28 unfinished package package 62207-623 62207-623-97 UNFINISHED Active or certified unfinished drug listing unfinished / ndc_unfinished.zip bbbc9f937eca…946b9c97cf81…2025-02-27 05:24 UTC · source 2025-02-26 unfinished package package 62207-623 62207-623-97 UNFINISHED Active or certified unfinished drug listing unfinished / ndc_unfinished.zip f268b84574a6…26285f5ac5df…2025-02-01 13:13 UTC · source 2025-01-31 unfinished package package 62207-623 62207-623-97 UNFINISHED Active or certified unfinished drug listing unfinished / ndc_unfinished.zip f764e8902f78…92046438deef…2025-01-20 13:05 UTC · source 2025-01-17 unfinished package package 62207-623 62207-623-97 UNFINISHED Active or certified unfinished drug listing unfinished / ndc_unfinished.zip 68b1e3bced9e…98a755eb8bc6…2024-11-29 20:42 UTC · source 2024-11-29 unfinished package package 62207-623 62207-623-97 UNFINISHED Active or certified unfinished drug listing unfinished / ndc_unfinished.zip 05c55d027831…ca05dca9dc4c…2024-11-09 02:36 UTC · source 2024-11-08 unfinished package package 62207-623 62207-623-97 UNFINISHED Active or certified unfinished drug listing unfinished / ndc_unfinished.zip 48b4f40e6753…c7c7a00d2afa…2024-10-09 02:27 UTC · source 2024-10-08 unfinished package package 62207-623 62207-623-97 UNFINISHED Active or certified unfinished drug listing unfinished / ndc_unfinished.zip 27f29a85d7e4…1372111e901f…2024-07-10 04:00 UTC · source 2024-07-09 unfinished package package 62207-623 62207-623-97 UNFINISHED Active or certified unfinished drug listing unfinished / ndc_unfinished.zip 8d62ce987f31…9fe9ef23e30d…2024-05-28 21:11 UTC · source 2024-05-28 unfinished package package 62207-623 62207-623-97 UNFINISHED Active or certified unfinished drug listing unfinished / ndc_unfinished.zip d1e113ab4d42…063ee3eb0a1d…2024-05-15 03:51 UTC · source 2024-05-14 unfinished package package 62207-623 62207-623-97 UNFINISHED Active or certified unfinished drug listing unfinished / ndc_unfinished.zip 50b4072663b7…eae3003ed65e…
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.
Product history page 1 of 2 · 78 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 2026-02-19 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…2021-12-28 21:50 UTC 2021-12 A211075-001 FEXOFENADINE HYDROCHLORIDE ALLERGY 60MG TABLET / ORAL 2019-10-18 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A211075-002 FEXOFENADINE HYDROCHLORIDE ALLERGY 180MG TABLET / ORAL 2019-10-18 782e0a99824c…
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 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
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Status 62207-623-97 62207062397 40000 TABLET in 1 DRUM (62207-623-97) 40000 tablet 27-NOV-23 Current