Home NDC 70677-1009 Fexofenadine Hydrochloride
Product NDC 70677-1009
11-digit product format 706771009
Labeler code 70677
Product ID 70677-1009_1982b8ab-b306-c1f8-0490-943207d2b606
Type HUMAN OTC DRUG
Nonproprietary name Fexofenadine hydrochloride
Dosage form TABLET
Route ORAL
Labeler Strategic Sourcing Services, LLC
Application ANDA076502
Marketing category ANDA
Marketing start 2019-09-09
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 Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 9 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A076502-001 FEXOFENADINE HYDROCHLORIDE FEXOFENADINE HYDROCHLORIDE 30MG TABLET / ORAL 2006-04-11 A076502-002 FEXOFENADINE HYDROCHLORIDE FEXOFENADINE HYDROCHLORIDE 60MG TABLET / ORAL 2006-04-11 A076502-003 FEXOFENADINE HYDROCHLORIDE FEXOFENADINE HYDROCHLORIDE 180MG TABLET / ORAL 2006-04-11 A076502-004 CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY FEXOFENADINE HYDROCHLORIDE 30MG TABLET / ORAL 2011-04-12 A076502-005 CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES FEXOFENADINE HYDROCHLORIDE 30MG TABLET / ORAL 2011-04-12 A076502-006 FEXOFENADINE HYDROCHLORIDE ALLERGY FEXOFENADINE HYDROCHLORIDE 60MG TABLET / ORAL 2011-04-12 A076502-007 FEXOFENADINE HYDROCHLORIDE HIVES FEXOFENADINE HYDROCHLORIDE 60MG TABLET / ORAL 2011-04-12 A076502-008 FEXOFENADINE HYDROCHLORIDE ALLERGY FEXOFENADINE HYDROCHLORIDE 180MG TABLET / ORAL 2011-04-12 A076502-009 FEXOFENADINE HYDROCHLORIDE HIVES FEXOFENADINE HYDROCHLORIDE 180MG TABLET / ORAL 2011-04-12
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 10 · 387 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 A076502-001 FEXOFENADINE HYDROCHLORIDE 30MG TABLET / ORAL 2006-04-11 84e616aacf4f…2026-09-14 22:38:34 2026-08 A076502-002 FEXOFENADINE HYDROCHLORIDE 60MG TABLET / ORAL 2006-04-11 84e616aacf4f…2026-09-14 22:38:34 2026-08 A076502-003 FEXOFENADINE HYDROCHLORIDE 180MG TABLET / ORAL 2006-04-11 84e616aacf4f…2026-09-14 22:38:34 2026-08 A076502-004 CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY 30MG TABLET / ORAL 2011-04-12 84e616aacf4f…2026-09-14 22:38:34 2026-08 A076502-005 CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES 30MG TABLET / ORAL 2011-04-12 84e616aacf4f…2026-09-14 22:38:34 2026-08 A076502-006 FEXOFENADINE HYDROCHLORIDE ALLERGY 60MG TABLET / ORAL 2011-04-12 84e616aacf4f…2026-09-14 22:38:34 2026-08 A076502-007 FEXOFENADINE HYDROCHLORIDE HIVES 60MG TABLET / ORAL 2011-04-12 84e616aacf4f…2026-09-14 22:38:34 2026-08 A076502-008 FEXOFENADINE HYDROCHLORIDE ALLERGY 180MG TABLET / ORAL 2011-04-12 84e616aacf4f…2026-09-14 22:38:34 2026-08 A076502-009 FEXOFENADINE HYDROCHLORIDE HIVES 180MG TABLET / ORAL 2011-04-12 84e616aacf4f…2026-08-18 06:07:40 2026-07 A076502-001 FEXOFENADINE HYDROCHLORIDE 30MG TABLET / ORAL 2006-04-11 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A076502-002 FEXOFENADINE HYDROCHLORIDE 60MG TABLET / ORAL 2006-04-11 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A076502-003 FEXOFENADINE HYDROCHLORIDE 180MG TABLET / ORAL 2006-04-11 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A076502-004 CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY 30MG TABLET / ORAL 2011-04-12 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A076502-005 CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES 30MG TABLET / ORAL 2011-04-12 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A076502-006 FEXOFENADINE HYDROCHLORIDE ALLERGY 60MG TABLET / ORAL 2011-04-12 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A076502-007 FEXOFENADINE HYDROCHLORIDE HIVES 60MG TABLET / ORAL 2011-04-12 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A076502-008 FEXOFENADINE HYDROCHLORIDE ALLERGY 180MG TABLET / ORAL 2011-04-12 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A076502-009 FEXOFENADINE HYDROCHLORIDE HIVES 180MG TABLET / ORAL 2011-04-12 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A076502-001 FEXOFENADINE HYDROCHLORIDE 30MG TABLET / ORAL AB 2006-04-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A076502-002 FEXOFENADINE HYDROCHLORIDE 60MG TABLET / ORAL AB 2006-04-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A076502-003 FEXOFENADINE HYDROCHLORIDE 180MG TABLET / ORAL AB 2006-04-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A076502-004 CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY 30MG TABLET / ORAL 2011-04-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A076502-005 CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES 30MG TABLET / ORAL 2011-04-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A076502-006 FEXOFENADINE HYDROCHLORIDE ALLERGY 60MG TABLET / ORAL 2011-04-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A076502-007 FEXOFENADINE HYDROCHLORIDE HIVES 60MG TABLET / ORAL 2011-04-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A076502-008 FEXOFENADINE HYDROCHLORIDE ALLERGY 180MG TABLET / ORAL 2011-04-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A076502-009 FEXOFENADINE HYDROCHLORIDE HIVES 180MG TABLET / ORAL 2011-04-12 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076502-001 FEXOFENADINE HYDROCHLORIDE 30MG TABLET / ORAL AB 2006-04-11 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076502-002 FEXOFENADINE HYDROCHLORIDE 60MG TABLET / ORAL AB 2006-04-11 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076502-003 FEXOFENADINE HYDROCHLORIDE 180MG TABLET / ORAL AB 2006-04-11 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076502-004 CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY 30MG TABLET / ORAL 2011-04-12 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076502-005 CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES 30MG TABLET / ORAL 2011-04-12 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076502-006 FEXOFENADINE HYDROCHLORIDE ALLERGY 60MG TABLET / ORAL 2011-04-12 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076502-007 FEXOFENADINE HYDROCHLORIDE HIVES 60MG TABLET / ORAL 2011-04-12 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076502-008 FEXOFENADINE HYDROCHLORIDE ALLERGY 180MG TABLET / ORAL 2011-04-12 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076502-009 FEXOFENADINE HYDROCHLORIDE HIVES 180MG TABLET / ORAL 2011-04-12 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A076502-001 FEXOFENADINE HYDROCHLORIDE 30MG TABLET / ORAL AB 2006-04-11 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A076502-002 FEXOFENADINE HYDROCHLORIDE 60MG TABLET / ORAL AB 2006-04-11 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A076502-003 FEXOFENADINE HYDROCHLORIDE 180MG TABLET / ORAL AB 2006-04-11 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A076502-004 CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY 30MG TABLET / ORAL 2011-04-12 6a471c1ec25d…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 120 observed states.
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 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 70677-1009-1 Fexofenadine Hydrochloride 3 in 1 CARTON TABLET 3 1 70677-1009-1 Fexofenadine Hydrochloride 5 in 1 BLISTER PACK TABLET 5 1 70677-1009-2 Fexofenadine Hydrochloride 30 in 1 BOTTLE TABLET 30 1 70677-1009-2 Fexofenadine Hydrochloride 1 in 1 CARTON TABLET 1 1 70677-1009-3 Fexofenadine Hydrochloride 70 in 1 BOTTLE TABLET 70 1 70677-1009-3 Fexofenadine Hydrochloride 1 in 1 CARTON TABLET 1 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70677-1009 FEXOFENADINE HYDROCHLORIDE TABLET [STRATEGIC SOURCING SERVICES, LLC] 1 Current NDC, 6 package rows 20230422_de438313-9790-b4ea-2d28-7a19836cf5e2.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 · 17 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 70677-1009-1 70677100901 3 BLISTER PACK in 1 CARTON (70677-1009-1) / 5 TABLET in 1 BLISTER PACK 3 blister pack 2023-05-05 No No Current 70677-1009-2 70677100902 1 BOTTLE in 1 CARTON (70677-1009-2) / 30 TABLET in 1 BOTTLE 1 bottle 2023-05-05 No No Current 70677-1009-3 70677100903 1 BOTTLE in 1 CARTON (70677-1009-3) / 70 TABLET in 1 BOTTLE 1 bottle 2023-05-05 No No Current