Home NDC 55648-987 Fexofenadine
Product NDC 55648-987
11-digit product format 556480987
Labeler code 55648
Product ID 55648-987_865eb588-6553-4222-b98e-3759fab38f2d
Type HUMAN OTC DRUG
Nonproprietary name Fexofenadine
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Wockhardt Limited
Application ANDA079112
Marketing category ANDA
Marketing start 2012-02-08
Marketing end 0000-00-00
Substance FEXOFENADINE HYDROCHLORIDE
Active strength 180 mg/1
NDC exclude flag E
Listing certified through 2018-12-31
Current FDA listing Historical FDA.report record
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 3 · 154 matching rows.
View current auxiliary records. · View the auxiliary file history.
Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
Orange Book products# Current product rows page 1 of 1 · 6 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A079112-001 CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES FEXOFENADINE HYDROCHLORIDE 30MG TABLET / ORAL 2012-02-08 A079112-002 CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY FEXOFENADINE HYDROCHLORIDE 30MG TABLET / ORAL 2012-02-08 A079112-003 FEXOFENADINE HYDROCHLORIDE HIVES FEXOFENADINE HYDROCHLORIDE 60MG TABLET / ORAL 2012-02-08 A079112-004 FEXOFENADINE HYDROCHLORIDE ALLERGY FEXOFENADINE HYDROCHLORIDE 60MG TABLET / ORAL 2012-02-08 A079112-005 FEXOFENADINE HYDROCHLORIDE HIVES FEXOFENADINE HYDROCHLORIDE 180MG TABLET / ORAL 2012-02-08 A079112-006 FEXOFENADINE HYDROCHLORIDE ALLERGY FEXOFENADINE HYDROCHLORIDE 180MG TABLET / ORAL 2012-02-08
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 7 · 264 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 A079112-001 CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES 30MG TABLET / ORAL 2012-02-08 c2088c7a36db…2026-10-15 13:18:30 2026-09 A079112-002 CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY 30MG TABLET / ORAL 2012-02-08 c2088c7a36db…2026-10-15 13:18:30 2026-09 A079112-003 FEXOFENADINE HYDROCHLORIDE HIVES 60MG TABLET / ORAL 2012-02-08 c2088c7a36db…2026-10-15 13:18:30 2026-09 A079112-004 FEXOFENADINE HYDROCHLORIDE ALLERGY 60MG TABLET / ORAL 2012-02-08 c2088c7a36db…2026-10-15 13:18:30 2026-09 A079112-005 FEXOFENADINE HYDROCHLORIDE HIVES 180MG TABLET / ORAL 2012-02-08 c2088c7a36db…2026-10-15 13:18:30 2026-09 A079112-006 FEXOFENADINE HYDROCHLORIDE ALLERGY 180MG TABLET / ORAL 2012-02-08 c2088c7a36db…2026-09-14 22:38:34 2026-08 A079112-001 CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES 30MG TABLET / ORAL 2012-02-08 84e616aacf4f…2026-09-14 22:38:34 2026-08 A079112-002 CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY 30MG TABLET / ORAL 2012-02-08 84e616aacf4f…2026-09-14 22:38:34 2026-08 A079112-003 FEXOFENADINE HYDROCHLORIDE HIVES 60MG TABLET / ORAL 2012-02-08 84e616aacf4f…2026-09-14 22:38:34 2026-08 A079112-004 FEXOFENADINE HYDROCHLORIDE ALLERGY 60MG TABLET / ORAL 2012-02-08 84e616aacf4f…2026-09-14 22:38:34 2026-08 A079112-005 FEXOFENADINE HYDROCHLORIDE HIVES 180MG TABLET / ORAL 2012-02-08 84e616aacf4f…2026-09-14 22:38:34 2026-08 A079112-006 FEXOFENADINE HYDROCHLORIDE ALLERGY 180MG TABLET / ORAL 2012-02-08 84e616aacf4f…2026-08-18 06:07:40 2026-07 A079112-001 CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES 30MG TABLET / ORAL 2012-02-08 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A079112-002 CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY 30MG TABLET / ORAL 2012-02-08 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A079112-003 FEXOFENADINE HYDROCHLORIDE HIVES 60MG TABLET / ORAL 2012-02-08 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A079112-004 FEXOFENADINE HYDROCHLORIDE ALLERGY 60MG TABLET / ORAL 2012-02-08 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A079112-005 FEXOFENADINE HYDROCHLORIDE HIVES 180MG TABLET / ORAL 2012-02-08 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A079112-006 FEXOFENADINE HYDROCHLORIDE ALLERGY 180MG TABLET / ORAL 2012-02-08 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A079112-001 CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES 30MG TABLET / ORAL 2012-02-08 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A079112-002 CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY 30MG TABLET / ORAL 2012-02-08 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A079112-003 FEXOFENADINE HYDROCHLORIDE HIVES 60MG TABLET / ORAL 2012-02-08 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A079112-004 FEXOFENADINE HYDROCHLORIDE ALLERGY 60MG TABLET / ORAL 2012-02-08 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A079112-005 FEXOFENADINE HYDROCHLORIDE HIVES 180MG TABLET / ORAL 2012-02-08 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A079112-006 FEXOFENADINE HYDROCHLORIDE ALLERGY 180MG TABLET / ORAL 2012-02-08 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A079112-001 CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES 30MG TABLET / ORAL 2012-02-08 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A079112-002 CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY 30MG TABLET / ORAL 2012-02-08 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A079112-003 FEXOFENADINE HYDROCHLORIDE HIVES 60MG TABLET / ORAL 2012-02-08 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A079112-004 FEXOFENADINE HYDROCHLORIDE ALLERGY 60MG TABLET / ORAL 2012-02-08 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A079112-005 FEXOFENADINE HYDROCHLORIDE HIVES 180MG TABLET / ORAL 2012-02-08 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A079112-006 FEXOFENADINE HYDROCHLORIDE ALLERGY 180MG TABLET / ORAL 2012-02-08 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A079112-001 CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES 30MG TABLET / ORAL 2012-02-08 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A079112-002 CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY 30MG TABLET / ORAL 2012-02-08 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A079112-003 FEXOFENADINE HYDROCHLORIDE HIVES 60MG TABLET / ORAL 2012-02-08 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A079112-004 FEXOFENADINE HYDROCHLORIDE ALLERGY 60MG TABLET / ORAL 2012-02-08 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A079112-005 FEXOFENADINE HYDROCHLORIDE HIVES 180MG TABLET / ORAL 2012-02-08 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A079112-006 FEXOFENADINE HYDROCHLORIDE ALLERGY 180MG TABLET / ORAL 2012-02-08 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A079112-001 CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES 30MG TABLET / ORAL 2012-02-08 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A079112-002 CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY 30MG TABLET / ORAL 2012-02-08 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A079112-003 FEXOFENADINE HYDROCHLORIDE HIVES 60MG TABLET / ORAL 2012-02-08 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A079112-004 FEXOFENADINE HYDROCHLORIDE ALLERGY 60MG TABLET / ORAL 2012-02-08 fd3edfee7708…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 55648-987-05 Fexofenadine 2000 in 1 POUCH TABLET, FILM COATED 2000 1 55648-987-09 Fexofenadine 5 in 1 BLISTER PACK TABLET, FILM COATED 5 1 55648-987-10 Fexofenadine 1 in 1 CARTON TABLET, FILM COATED 1 1 55648-987-11 Fexofenadine 3 in 1 CARTON TABLET, FILM COATED 3 1 55648-987-12 Fexofenadine 30 in 1 BOTTLE TABLET, FILM COATED 30 1 55648-987-12 Fexofenadine 1 in 1 CARTON TABLET, FILM COATED 1 1 55648-987-13 Fexofenadine 45 in 1 BOTTLE TABLET, FILM COATED 45 1 55648-987-13 Fexofenadine 1 in 1 CARTON TABLET, FILM COATED 1 1 55648-987-14 Fexofenadine 45 in 1 BOTTLE TABLET, FILM COATED 45 1 55648-987-14 Fexofenadine 2 in 1 CARTON TABLET, FILM COATED 2 1
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded FEXOFENADINE HYDROCHLORIDE ACTIVE INGREDIENT 2S068B75ZU ALLERGY RELIEF (FEXOFENADINE HCL) TABLET [P AND L DEVELOPMENT OF NEW YORK CORPORATION] 1 FEXOFENADINE HYDROCHLORIDE ACTIVE INGREDIENT 2S068B75ZU FEXOFENADINE TABLET, FILM COATED [WOCKHARDT LIMITED] 1 FEXOFENADINE HYDROCHLORIDE ACTIVE INGREDIENT 2S068B75ZU FEXOFENADINE HCL TABLET [VALU MERCHANDISERS COMPANY (BEST CHOICE)] 1 FEXOFENADINE ACTIVE MOIETY E6582LOH6V FEXOFENADINE HCL TABLET [VALU MERCHANDISERS COMPANY (BEST CHOICE)] 1 FEXOFENADINE ACTIVE MOIETY E6582LOH6V ALLERGY RELIEF (FEXOFENADINE HCL) TABLET [P AND L DEVELOPMENT OF NEW YORK CORPORATION] 1 FEXOFENADINE ACTIVE MOIETY E6582LOH6V FEXOFENADINE TABLET, FILM COATED [WOCKHARDT LIMITED] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U ALLERGY RELIEF (FEXOFENADINE HCL) TABLET [P AND L DEVELOPMENT OF NEW YORK CORPORATION] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U FEXOFENADINE HCL TABLET [VALU MERCHANDISERS COMPANY (BEST CHOICE)] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U FEXOFENADINE TABLET, FILM COATED [WOCKHARDT LIMITED] 1 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 ALLERGY RELIEF (FEXOFENADINE HCL) TABLET [P AND L DEVELOPMENT OF NEW YORK CORPORATION] 1 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 FEXOFENADINE HCL TABLET [VALU MERCHANDISERS COMPANY (BEST CHOICE)] 1 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 FEXOFENADINE TABLET, FILM COATED [WOCKHARDT LIMITED] 1 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 FEXOFENADINE HCL TABLET [VALU MERCHANDISERS COMPANY (BEST CHOICE)] 1 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 ALLERGY RELIEF (FEXOFENADINE HCL) TABLET [P AND L DEVELOPMENT OF NEW YORK CORPORATION] 1 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT ALLERGY RELIEF (FEXOFENADINE HCL) TABLET [P AND L DEVELOPMENT OF NEW YORK CORPORATION] 1 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT FEXOFENADINE HCL TABLET [VALU MERCHANDISERS COMPANY (BEST CHOICE)] 1 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO FEXOFENADINE HCL TABLET [VALU MERCHANDISERS COMPANY (BEST CHOICE)] 1 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO FEXOFENADINE TABLET, FILM COATED [WOCKHARDT LIMITED] 1 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO ALLERGY RELIEF (FEXOFENADINE HCL) TABLET [P AND L DEVELOPMENT OF NEW YORK CORPORATION] 1 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X FEXOFENADINE TABLET, FILM COATED [WOCKHARDT LIMITED] 1 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X FEXOFENADINE HCL TABLET [VALU MERCHANDISERS COMPANY (BEST CHOICE)] 1 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X ALLERGY RELIEF (FEXOFENADINE HCL) TABLET [P AND L DEVELOPMENT OF NEW YORK CORPORATION] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 FEXOFENADINE HCL TABLET [VALU MERCHANDISERS COMPANY (BEST CHOICE)] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 ALLERGY RELIEF (FEXOFENADINE HCL) TABLET [P AND L DEVELOPMENT OF NEW YORK CORPORATION] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 FEXOFENADINE TABLET, FILM COATED [WOCKHARDT LIMITED] 1 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A FEXOFENADINE HCL TABLET [VALU MERCHANDISERS COMPANY (BEST CHOICE)] 1 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A ALLERGY RELIEF (FEXOFENADINE HCL) TABLET [P AND L DEVELOPMENT OF NEW YORK CORPORATION] 1 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A FEXOFENADINE TABLET, FILM COATED [WOCKHARDT LIMITED] 1 POVIDONE K30 INACTIVE INGREDIENT U725QWY32X ALLERGY RELIEF (FEXOFENADINE HCL) TABLET [P AND L DEVELOPMENT OF NEW YORK CORPORATION] 1 POVIDONE K30 INACTIVE INGREDIENT U725QWY32X FEXOFENADINE TABLET, FILM COATED [WOCKHARDT LIMITED] 1 POVIDONES INACTIVE INGREDIENT FZ989GH94E FEXOFENADINE HCL TABLET [VALU MERCHANDISERS COMPANY (BEST CHOICE)] 1 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 FEXOFENADINE TABLET, FILM COATED [WOCKHARDT LIMITED] 1 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 FEXOFENADINE HCL TABLET [VALU MERCHANDISERS COMPANY (BEST CHOICE)] 1 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 ALLERGY RELIEF (FEXOFENADINE HCL) TABLET [P AND L DEVELOPMENT OF NEW YORK CORPORATION] 1 TALC INACTIVE INGREDIENT 7SEV7J4R1U FEXOFENADINE TABLET, FILM COATED [WOCKHARDT LIMITED] 1 TALC INACTIVE INGREDIENT 7SEV7J4R1U FEXOFENADINE HCL TABLET [VALU MERCHANDISERS COMPANY (BEST CHOICE)] 1 TALC INACTIVE INGREDIENT 7SEV7J4R1U ALLERGY RELIEF (FEXOFENADINE HCL) TABLET [P AND L DEVELOPMENT OF NEW YORK CORPORATION] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP ALLERGY RELIEF (FEXOFENADINE HCL) TABLET [P AND L DEVELOPMENT OF NEW YORK CORPORATION] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP FEXOFENADINE HCL TABLET [VALU MERCHANDISERS COMPANY (BEST CHOICE)] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP FEXOFENADINE TABLET, FILM COATED [WOCKHARDT LIMITED] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 55648-987 FEXOFENADINE TABLET, FILM COATED [WOCKHARDT LIMITED] 1 Legacy NDC, 10 package rows 20120509_db8d895c-1004-4d5b-bc0d-81f192bfc7b0.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Status 55648-987-05 55648098705 2000 in 1 POUCH Historical 55648-987-09 55648098709 5 in 1 BLISTER PACK Historical 55648-987-10 55648098710 1 in 1 CARTON Historical 55648-987-11 55648098711 3 in 1 CARTON Historical 55648-987-12 55648098712 30 in 1 BOTTLE Historical 55648-987-13 55648098713 45 in 1 BOTTLE Historical 55648-987-14 55648098714 45 in 1 BOTTLE Historical