Home NDC 62207-891-51 Fexofenadine Hydrochloride
Product NDC 62207-891
Requested package NDC 62207-891-51
11-digit product format 622070891
Labeler code 62207
Product ID 62207-891_5447e2c4-49cb-5f8d-e063-6294a90a2457
Type HUMAN OTC DRUG
Nonproprietary name Fexofenadine Hydrochloride
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Granules India Limited
Application ANDA211075
Marketing category ANDA
Marketing start 2023-11-07
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 Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 3 · 82 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 2026-09-14 22:38:34 2026-08 A211075-001 FEXOFENADINE HYDROCHLORIDE ALLERGY 60MG TABLET / ORAL 2019-10-18 84e616aacf4f…2026-09-14 22:38:34 2026-08 A211075-002 FEXOFENADINE HYDROCHLORIDE ALLERGY 180MG TABLET / ORAL 2019-10-18 84e616aacf4f…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…
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 Hydrochloride
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 62207-891-49 Fexofenadine Hydrochloride 1000 in 1 BOTTLE TABLET, FILM COATED 1000 3 62207-891-51 Fexofenadine Hydrochloride 1 in 1 CARTON TABLET, FILM COATED 1 3 62207-891-51 Fexofenadine Hydrochloride 10 in 1 BOTTLE TABLET, FILM COATED 10 3 62207-891-58 Fexofenadine Hydrochloride 10 in 1 BLISTER PACK TABLET, FILM COATED 10 3 62207-891-58 Fexofenadine Hydrochloride 7 in 1 CARTON TABLET, FILM COATED 7 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 62207-891 FEXOFENADINE HYDROCHLORIDE (FEXOFENADINE HYDROCHLORIDE) TABLET, FILM COATED [GRANULES INDIA LIMITED] 2 Current NDC, 5 package rows 20231114_e0537b71-fdee-4122-9c09-868ce7352080.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 62207-891-51 62207089151 1 BOTTLE in 1 CARTON (62207-891-51) / 10 TABLET, FILM COATED in 1 BOTTLE 1 bottle 2023-11-07 No No Current