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

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 7 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	55648-987		I	Inactivated by FDA	2026-07-31
excluded package	package	55648-987	55648-987-05	I	Inactivated by FDA	2026-07-31
excluded package	package	55648-987	55648-987-10	I	Inactivated by FDA	2026-07-31
excluded package	package	55648-987	55648-987-11	I	Inactivated by FDA	2026-07-31
excluded package	package	55648-987	55648-987-12	I	Inactivated by FDA	2026-07-31
excluded package	package	55648-987	55648-987-13	I	Inactivated by FDA	2026-07-31
excluded package	package	55648-987	55648-987-14	I	Inactivated by FDA	2026-07-31

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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	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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-08-01 22:54:32	2026-06	A079112-001	CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES	30MG	TABLET / ORAL	2012-02-08	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A079112-002	CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY	30MG	TABLET / ORAL	2012-02-08	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A079112-003	FEXOFENADINE HYDROCHLORIDE HIVES	60MG	TABLET / ORAL	2012-02-08	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A079112-004	FEXOFENADINE HYDROCHLORIDE ALLERGY	60MG	TABLET / ORAL	2012-02-08	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A079112-005	FEXOFENADINE HYDROCHLORIDE HIVES	180MG	TABLET / ORAL	2012-02-08	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A079112-006	FEXOFENADINE HYDROCHLORIDE ALLERGY	180MG	TABLET / ORAL	2012-02-08	`a50c72e98297…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
b893258d-0942-3d8a-3411-056ea0788ff5	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
55648-987-05	2020-01-31	C162847	48780-1	9d75b9d1-0a9b-f424-e053-dadaa90a57ce	Fexofenadine Tablets
55648-987-10	2020-01-31	C162847	48780-1	9d75b9d1-0a9b-f424-e053-dadaa90a57ce	Fexofenadine Tablets
55648-987-11	2020-01-31	C162847	48780-1	9d75b9d1-0a9b-f424-e053-dadaa90a57ce	Fexofenadine Tablets
55648-987-12	2020-01-31	C162847	48780-1	9d75b9d1-0a9b-f424-e053-dadaa90a57ce	Fexofenadine Tablets
55648-987-13	2020-01-31	C162847	48780-1	9d75b9d1-0a9b-f424-e053-dadaa90a57ce	Fexofenadine Tablets
55648-987-14	2020-01-31	C162847	48780-1	9d75b9d1-0a9b-f424-e053-dadaa90a57ce	Fexofenadine Tablets

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	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
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

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
2S068B75ZU	FEXOFENADINE HYDROCHLORIDE	153439-40-8	FEXOFENADINE HYDROCHLORIDE
E6582LOH6V	FEXOFENADINE	83799-24-0	Fexofenadine

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
997420	fexofenadine HCl 180 MG 24 HR Oral Tablet	PSN	db8d895c-1004-4d5b-bc0d-81f192bfc7b0	1
997420	fexofenadine HCl 180 MG 24 HR Oral Tablet	PSN	efc8863d-a66f-4757-99f5-8358d9b8b17d	1
997488	fexofenadine HCl 30 MG Oral Tablet	PSN	db8d895c-1004-4d5b-bc0d-81f192bfc7b0	1
997501	fexofenadine HCl 60 MG Oral Tablet	PSN	db8d895c-1004-4d5b-bc0d-81f192bfc7b0	1
997420	fexofenadine hydrochloride 180 MG Oral Tablet	SCD	db8d895c-1004-4d5b-bc0d-81f192bfc7b0	1
997420	fexofenadine hydrochloride 180 MG Oral Tablet	SCD	efc8863d-a66f-4757-99f5-8358d9b8b17d	1
997488	fexofenadine hydrochloride 30 MG Oral Tablet	SCD	db8d895c-1004-4d5b-bc0d-81f192bfc7b0	1
997501	fexofenadine hydrochloride 60 MG Oral Tablet	SCD	db8d895c-1004-4d5b-bc0d-81f192bfc7b0	1
997420	fexofenadine HCl 180 MG 24 HR Oral Tablet	SY	db8d895c-1004-4d5b-bc0d-81f192bfc7b0	1
997420	fexofenadine HCl 180 MG 24 HR Oral Tablet	SY	efc8863d-a66f-4757-99f5-8358d9b8b17d	1

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

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
DRUG FACTS	P and L Development of New York Corporation	2012-12-20	HUMAN OTC DRUG LABEL	1
DRUG FACTS	Valu Merchandisers Company (Best Choice) \| P and L Development of New York Corporation	2012-11-15	HUMAN OTC DRUG LABEL	1
Fexofenadine Tablets	Wockhardt Limited	2012-05-08	HUMAN OTC DRUG LABEL	1