Fexofenadine Hydrochloride

Product NDC: 21695-461
11-digit product format: 216950461
Labeler code: 21695
Product ID: 21695-461_2db62c07-21be-4378-82fc-a1bd9dc6e3ba
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Fexofenadine Hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: Rebel Distributors Corp
Application: ANDA076502
Marketing category: ANDA
Marketing start: 2009-12-09
Marketing end: 0000-00-00
Substance: FEXOFENADINE HYDROCHLORIDE
Active strength: 60 mg/1
Pharmacologic classes: Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC]
NDC exclude flag: E
Listing certified through: 2017-12-31
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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	21695-461		I	Inactivated by FDA	2026-08-07
excluded package	package	21695-461	21695-461-14	I	Inactivated by FDA	2026-08-07
excluded package	package	21695-461	21695-461-20	I	Inactivated by FDA	2026-08-07

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 2 · 66 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	21695-461-14	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	21695-461-20	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	21695-461-14	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	21695-461-20	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	21695-461-14	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	21695-461-20	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	21695-461-14	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	21695-461-20	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	21695-461-14	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	21695-461-20	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	21695-461-14	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	21695-461-20	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	21695-461-14	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	21695-461-20	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	21695-461-14	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	21695-461-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	21695-461-14	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	21695-461-20	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	21695-461-14	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	21695-461-20	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	21695-461-14	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	21695-461-20	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	21695-461-14	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	21695-461-20	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	21695-461-14	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	21695-461-20	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	21695-461-14	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	21695-461-20	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	21695-461-14	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	21695-461-20	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	21695-461-14	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	21695-461-20	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	21695-461-14	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	21695-461-20	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	21695-461-14	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	21695-461-20	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	21695-461-14	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	21695-461-20	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	21695-461-14	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	21695-461-20	`e2bbac7714bc…`	`27bdfed8d636…`

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

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	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 · 369 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
2026-02-19 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…`
2025-08-23 18:47 UTC	2025-08	A076502-005	CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES	30MG	TABLET / ORAL		2011-04-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076502-006	FEXOFENADINE HYDROCHLORIDE ALLERGY	60MG	TABLET / ORAL		2011-04-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076502-007	FEXOFENADINE HYDROCHLORIDE HIVES	60MG	TABLET / ORAL		2011-04-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076502-008	FEXOFENADINE HYDROCHLORIDE ALLERGY	180MG	TABLET / ORAL		2011-04-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076502-009	FEXOFENADINE HYDROCHLORIDE HIVES	180MG	TABLET / ORAL		2011-04-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076502-001	FEXOFENADINE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2006-04-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076502-002	FEXOFENADINE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2006-04-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076502-003	FEXOFENADINE HYDROCHLORIDE	180MG	TABLET / ORAL	AB	2006-04-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076502-004	CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY	30MG	TABLET / ORAL		2011-04-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076502-005	CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES	30MG	TABLET / ORAL		2011-04-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076502-006	FEXOFENADINE HYDROCHLORIDE ALLERGY	60MG	TABLET / ORAL		2011-04-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076502-007	FEXOFENADINE HYDROCHLORIDE HIVES	60MG	TABLET / ORAL		2011-04-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076502-008	FEXOFENADINE HYDROCHLORIDE ALLERGY	180MG	TABLET / ORAL		2011-04-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076502-009	FEXOFENADINE HYDROCHLORIDE HIVES	180MG	TABLET / ORAL		2011-04-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076502-001	FEXOFENADINE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2006-04-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076502-002	FEXOFENADINE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2006-04-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076502-003	FEXOFENADINE HYDROCHLORIDE	180MG	TABLET / ORAL	AB	2006-04-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076502-004	CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY	30MG	TABLET / ORAL		2011-04-12	`b8a1b40f171c…`

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	A076502-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076502-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076502-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076502-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076502-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076502-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076502-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076502-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076502-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076502-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076502-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076502-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076502-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076502-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076502-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076502-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076502-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076502-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076502-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076502-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076502-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076502-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076502-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076502-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076502-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076502-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076502-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076502-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076502-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076502-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076502-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076502-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076502-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076502-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076502-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076502-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076502-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076502-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076502-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076502-001	AB	1	`8072bd15b7f6…`

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
21695-461-14	2019-09-24	C162847	48780-1	934fe258-48d5-48b1-e053-8cdaa90a720a	These highlights do not include all the information needed to use fexofenadine hydrochloride tablets safely and effectively. See full prescribing information for fexofenadine hydrochloride. Initial U.S. Approval: 1996
21695-461-20	2019-09-24	C162847	48780-1	934fe258-48d5-48b1-e053-8cdaa90a720a	These highlights do not include all the information needed to use fexofenadine hydrochloride tablets safely and effectively. See full prescribing information for fexofenadine hydrochloride. Initial U.S. Approval: 1996

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
21695-461-14	Fexofenadine Hydrochloride	14 in 1 BOTTLE	TABLET	14		2
21695-461-20	Fexofenadine Hydrochloride	20 in 1 BOTTLE	TABLET	20		2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
21695-461-20	EA - Each	21695-461	9f6b0721-dd8c-47c4-8981-e490dc448633	1	2013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
FEXOFENADINE HYDROCHLORIDE	ACTIVE INGREDIENT	2S068B75ZU	FEXOFENADINE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP]	2
FEXOFENADINE	ACTIVE MOIETY	E6582LOH6V	FEXOFENADINE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP]	2
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	FEXOFENADINE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP]	2
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	FEXOFENADINE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP]	2
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	FEXOFENADINE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP]	2
HYPROMELLOSE 2910 (6 MPA.S)	INACTIVE INGREDIENT	0WZ8WG20P6	FEXOFENADINE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	FEXOFENADINE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP]	2
MANNITOL	INACTIVE INGREDIENT	3OWL53L36A	FEXOFENADINE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP]	2
POLYETHYLENE GLYCOL 400	INACTIVE INGREDIENT	B697894SGQ	FEXOFENADINE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP]	2
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	FEXOFENADINE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP]	2
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	FEXOFENADINE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	FEXOFENADINE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
21695-461	FEXOFENADINE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP]	2	Legacy NDC, 2 package rows	20110201_e5a207e4-472b-4bf9-8cd3-a018ef3a82bb.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 · 18 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Fexofenadine hydrochloride	FEXOFENADINE HYDROCHLORIDE	BluePoint Laboratories	a86aebd0-937e-5d73-e053-2995a90a656a	2026-07-13	Warnings	Exact identifier application applno (ANDA): 076502 application number: ANDA076502
Fexofenadine hydrochloride	FEXOFENADINE HYDROCHLORIDE	Dr. Reddy's Laboratories Limited	864e3052-5787-bf11-9d17-11274ca2304f	2026-07-09	Warnings	Exact identifier application applno (ANDA): 076502 application number: ANDA076502
Fexofenadine Hydrochloride	FEXOFENADINE HYDROCHLORIDE	Dr. Reddy's Laboratories Inc.	b0121213-eae1-8429-9986-3b3b26f35e47	2026-07-09	Warnings	Exact identifier application applno (ANDA): 076502 application number: ANDA076502
Non-Drowsy Allergy Relief	FEXOFENADINE HYDROCHLORIDE	TARGET CORPORATION	3cf4b7fe-b1f7-b767-430a-655408f91753	2025-08-01	Warnings	Exact identifier application applno (ANDA): 076502 application number: ANDA076502
Fexofenadine hydrochloride	FEXOFENADINE HYDROCHLORIDE	MAJOR PHARMACEUTICALS	0a6da401-a8a3-5d0b-f37e-c220838f7e49	2025-07-27	Warnings	Exact identifier application applno (ANDA): 076502 application number: ANDA076502
Fexofenadine hydrochloride	FEXOFENADINE HYDROCHLORIDE	Walgreens Company	b961985e-0c18-b36f-d82e-32ff2d46fada	2025-07-18	Warnings	Exact identifier application applno (ANDA): 076502 application number: ANDA076502
Fexofenadine hydrochloride	FEXOFENADINE HYDROCHLORIDE	Dollar General	1b2a14a1-a5cc-4f5e-8127-57e9d913f50a	2024-11-12	Warnings	Exact identifier application applno (ANDA): 076502 application number: ANDA076502
Fexofenadine hydrochloride	FEXOFENADINE HYDROCHLORIDE	KROGER COMPANY	7b146260-c925-3238-d092-24b7101ceb50	2024-11-12	Warnings	Exact identifier application applno (ANDA): 076502 application number: ANDA076502
Fexofenadine hydrochloride	FEXOFENADINE HYDROCHLORIDE	Dr. Reddy's Laboratories Inc.	624b3a91-af4f-8848-6fc3-392e0df34cc8	2024-11-12	Warnings	Exact identifier application applno (ANDA): 076502 application number: ANDA076502
Fexofenadine Hydrochloride	FEXOFENADINE HYDROCHLORIDE	CVS Health Corp.	204506d7-7688-fd7e-0aae-142b698848ef	2024-11-12	Warnings	Exact identifier application applno (ANDA): 076502 application number: ANDA076502
Fexofenadine Hydrochloride	FEXOFENADINE HYDROCHLORIDE	Strategic Sourcing Services, LLC	de438313-9790-b4ea-2d28-7a19836cf5e2	2023-04-21	Warnings	Exact identifier application applno (ANDA): 076502 application number: ANDA076502
Allergy Relief	FEXOFENADINE HYDROCHLORIDE	Rite Aid Corporation	af2ef0bf-6cd2-b9a6-ff8f-6f50aac152ce	2022-06-12	Warnings	Exact identifier application applno (ANDA): 076502 application number: ANDA076502
Wal-Fex	FEXOFENADINE HYDROCHLORIDE	Walgreens Company	95d420ea-6337-304f-54c3-0c75be1608e2	2022-01-22	Warnings	Exact identifier application applno (ANDA): 076502 application number: ANDA076502
Allergy Relief	FEXOFENADINE HYDROCHLORIDE	Family Dollar Stores, Inc.	f532e9d5-6457-8bef-e83e-16050f20b03c	2020-02-19	Warnings	Exact identifier application applno (ANDA): 076502 application number: ANDA076502
Fexofenadine Hydrochloride	FEXOFENADINE HYDROCHLORIDE	Sam's West Inc.	1c1f43c4-7128-37c4-83fe-7eefac3fd477	2019-10-07	Warnings	Exact identifier application applno (ANDA): 076502 application number: ANDA076502
Allergy Relief	FEXOFENADINE HYDROCHLORIDE	Safeway Inc	3c30a1dc-a13d-2522-d4d0-00c1e9dbab07	2017-12-11	Warnings	Exact identifier application applno (ANDA): 076502 application number: ANDA076502
Fexofenadine Hydrochloride	FEXOFENADINE HYDROCHLORIDE	Chain Drug Consortium, LLC	d1d8d0ec-2bdd-fb07-a051-d6353e3c240c	2014-01-22	Warnings	Exact identifier application applno (ANDA): 076502 application number: ANDA076502
Fexofenadine Hydrochloride	FEXOFENADINE HYDROCHLORIDE	Chain Drug Marketing Associate	8a1de8a1-808a-bc08-6c74-957d6f388eab	2014-01-22	Warnings	Exact identifier application applno (ANDA): 076502 application number: ANDA076502

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

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	e5a207e4-472b-4bf9-8cd3-a018ef3a82bb	2
997501	fexofenadine HCl 60 MG Oral Tablet	PSN	e5a207e4-472b-4bf9-8cd3-a018ef3a82bb	2
997420	fexofenadine hydrochloride 180 MG Oral Tablet	SCD	e5a207e4-472b-4bf9-8cd3-a018ef3a82bb	2
997501	fexofenadine hydrochloride 60 MG Oral Tablet	SCD	e5a207e4-472b-4bf9-8cd3-a018ef3a82bb	2
997420	fexofenadine HCl 180 MG 24 HR Oral Tablet	SY	e5a207e4-472b-4bf9-8cd3-a018ef3a82bb	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
21695-461-14	21695046114	14 in 1 BOTTLE	Historical
21695-461-20	21695046120	20 in 1 BOTTLE	Historical