fexofenadine hydrochloride

Product NDC: 63629-6897
11-digit product format: 636296897
Labeler code: 63629
Product ID: 63629-6897_1d0c4be8-d884-4cbe-8df6-4f088811b78c
Type: HUMAN OTC DRUG
Nonproprietary name: fexofenadine hydrochloride
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Bryant Ranch Prepack
Application: ANDA076447
Marketing category: ANDA
Marketing start: 2011-04-22
Marketing end: 0000-00-00
Substance: FEXOFENADINE HYDROCHLORIDE
Active strength: 180 mg/1
NDC exclude flag: No
Listing certified through: 2021-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	63629-6897		D	Discontinued by firm		2026-10-05
excluded package	package	63629-6897	63629-6897-1	D	Discontinued by firm		2026-10-05

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 1 · 26 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	63629-6897-1	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	63629-6897-1	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	63629-6897-1	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	63629-6897-1	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	63629-6897-1	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	63629-6897-1	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	63629-6897-1	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	63629-6897-1	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	63629-6897-1	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	63629-6897-1	D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	63629-6897-1	D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	63629-6897-1	D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	63629-6897-1	I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 8 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	Approval date
A076447-001	FEXOFENADINE HYDROCHLORIDE	FEXOFENADINE HYDROCHLORIDE	30MG	TABLET / ORAL	2005-09-01
A076447-002	FEXOFENADINE HYDROCHLORIDE	FEXOFENADINE HYDROCHLORIDE	60MG	TABLET / ORAL	2005-09-01
A076447-003	FEXOFENADINE HYDROCHLORIDE	FEXOFENADINE HYDROCHLORIDE	180MG	TABLET / ORAL	2005-09-01
A076447-004	CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY	FEXOFENADINE HYDROCHLORIDE	30MG	TABLET / ORAL	2011-04-13
A076447-005	CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES	FEXOFENADINE HYDROCHLORIDE	30MG	TABLET / ORAL	2011-04-13
A076447-006	FEXOFENADINE HYDROCHLORIDE ALLERGY	FEXOFENADINE HYDROCHLORIDE	60MG	TABLET / ORAL	2011-04-13
A076447-007	FEXOFENADINE HYDROCHLORIDE HIVES	FEXOFENADINE HYDROCHLORIDE	60MG	TABLET / ORAL	2011-04-13
A076447-008	FEXOFENADINE HYDROCHLORIDE ALLERGY	FEXOFENADINE HYDROCHLORIDE	180MG	TABLET / ORAL	2011-04-13

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 9 · 344 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A076447-001	FEXOFENADINE HYDROCHLORIDE	30MG	TABLET / ORAL		2005-09-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076447-002	FEXOFENADINE HYDROCHLORIDE	60MG	TABLET / ORAL		2005-09-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076447-003	FEXOFENADINE HYDROCHLORIDE	180MG	TABLET / ORAL		2005-09-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076447-004	CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY	30MG	TABLET / ORAL		2011-04-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076447-005	CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES	30MG	TABLET / ORAL		2011-04-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076447-006	FEXOFENADINE HYDROCHLORIDE ALLERGY	60MG	TABLET / ORAL		2011-04-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076447-007	FEXOFENADINE HYDROCHLORIDE HIVES	60MG	TABLET / ORAL		2011-04-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076447-008	FEXOFENADINE HYDROCHLORIDE ALLERGY	180MG	TABLET / ORAL		2011-04-13	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A076447-001	FEXOFENADINE HYDROCHLORIDE	30MG	TABLET / ORAL		2005-09-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076447-002	FEXOFENADINE HYDROCHLORIDE	60MG	TABLET / ORAL		2005-09-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076447-003	FEXOFENADINE HYDROCHLORIDE	180MG	TABLET / ORAL		2005-09-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076447-004	CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY	30MG	TABLET / ORAL		2011-04-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076447-005	CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES	30MG	TABLET / ORAL		2011-04-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076447-006	FEXOFENADINE HYDROCHLORIDE ALLERGY	60MG	TABLET / ORAL		2011-04-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076447-007	FEXOFENADINE HYDROCHLORIDE HIVES	60MG	TABLET / ORAL		2011-04-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076447-008	FEXOFENADINE HYDROCHLORIDE ALLERGY	180MG	TABLET / ORAL		2011-04-13	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076447-001	FEXOFENADINE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2005-09-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076447-002	FEXOFENADINE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2005-09-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076447-003	FEXOFENADINE HYDROCHLORIDE	180MG	TABLET / ORAL	AB	2005-09-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076447-004	CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY	30MG	TABLET / ORAL		2011-04-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076447-005	CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES	30MG	TABLET / ORAL		2011-04-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076447-006	FEXOFENADINE HYDROCHLORIDE ALLERGY	60MG	TABLET / ORAL		2011-04-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076447-007	FEXOFENADINE HYDROCHLORIDE HIVES	60MG	TABLET / ORAL		2011-04-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076447-008	FEXOFENADINE HYDROCHLORIDE ALLERGY	180MG	TABLET / ORAL		2011-04-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076447-001	FEXOFENADINE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2005-09-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076447-002	FEXOFENADINE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2005-09-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076447-003	FEXOFENADINE HYDROCHLORIDE	180MG	TABLET / ORAL	AB	2005-09-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076447-004	CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY	30MG	TABLET / ORAL		2011-04-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076447-005	CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES	30MG	TABLET / ORAL		2011-04-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076447-006	FEXOFENADINE HYDROCHLORIDE ALLERGY	60MG	TABLET / ORAL		2011-04-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076447-007	FEXOFENADINE HYDROCHLORIDE HIVES	60MG	TABLET / ORAL		2011-04-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076447-008	FEXOFENADINE HYDROCHLORIDE ALLERGY	180MG	TABLET / ORAL		2011-04-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076447-001	FEXOFENADINE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2005-09-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076447-002	FEXOFENADINE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2005-09-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076447-003	FEXOFENADINE HYDROCHLORIDE	180MG	TABLET / ORAL	AB	2005-09-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076447-004	CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY	30MG	TABLET / ORAL		2011-04-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076447-005	CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES	30MG	TABLET / ORAL		2011-04-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076447-006	FEXOFENADINE HYDROCHLORIDE ALLERGY	60MG	TABLET / ORAL		2011-04-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076447-007	FEXOFENADINE HYDROCHLORIDE HIVES	60MG	TABLET / ORAL		2011-04-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076447-008	FEXOFENADINE HYDROCHLORIDE ALLERGY	180MG	TABLET / ORAL		2011-04-13	`6a471c1ec25d…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 120 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A076447-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076447-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076447-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076447-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076447-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076447-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076447-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076447-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076447-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076447-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076447-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076447-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076447-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076447-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076447-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076447-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076447-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076447-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076447-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076447-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076447-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076447-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076447-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076447-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076447-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076447-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076447-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076447-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076447-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076447-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076447-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076447-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076447-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076447-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076447-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076447-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076447-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076447-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076447-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076447-001	AB	1	`8072bd15b7f6…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
63629-6897-1	2020-10-16	C162847	48780-1	9d75b9d0-da5f-f424-e053-dadaa90a57ce	Perrigo Fexofenadine Hydrochloride Tablets, 180 mg Drug Facts
63629-6897-1	2020-01-31	C162847	48780-1	9d75b9d0-da5f-f424-e053-dadaa90a57ce	Perrigo Fexofenadine Hydrochloride Tablets, 180 mg Drug Facts

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
CareOne Allergy Relief	FEXOFENADINE HCL	American Sales Company	65720e72-c20d-4363-92ab-76596e043bc0	2021-07-12	Warnings	Exact identifier application applno (ANDA): 076447 application number: ANDA076447

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
2S068B75ZU	FEXOFENADINE HYDROCHLORIDE	153439-40-8	FEXOFENADINE HYDROCHLORIDE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
63629-6897-1	63629689701	30 TABLET, FILM COATED in 1 BOTTLE (63629-6897-1)	2016-01-21	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Perrigo Fexofenadine Hydrochloride Tablets, 180 mg Drug Facts	Bryant Ranch Prepack	2020-10-16	HUMAN OTC DRUG LABEL	3