Fexofenadine hydrochloride

Product NDC: 55111-783
11-digit product format: 551110783
Labeler code: 55111
Product ID: 55111-783_9c0b82c6-7eff-3eec-40e2-db72a8625eff
Type: HUMAN OTC DRUG
Nonproprietary name: Fexofenadine hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: Dr. Reddy's Laboratories Limited
Application: ANDA076502
Marketing category: ANDA
Marketing start: 2011-01-03
Substance: FEXOFENADINE HYDROCHLORIDE
Active strength: 60 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

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
unfinished product	product	55111-783		UNFINISHED	Active or certified unfinished drug listing	2026-08-07
unfinished package	package	55111-783	55111-783-94	UNFINISHED	Active or certified unfinished drug listing	2026-08-07
excluded package	package	55111-783	55111-783-30	D	Discontinued by firm	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 1 · 38 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	Archive	Snapshot	Source SHA-256
2025-12-14 21:27 UTC · source 2025-12-05	unfinished product	product		UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`a6255e0c9aa5…`	`a0211a219f2e…`
2025-12-14 21:27 UTC · source 2025-12-05	unfinished package	package	55111-783-94	UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`a6255e0c9aa5…`	`a0211a219f2e…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	55111-783-30	D	Discontinued by firm	excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	55111-783-30	D	Discontinued by firm	excluded / ndc_excluded.zip	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-26 23:59 UTC · source 2025-08-26	unfinished product	product		UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`1d862106b807…`	`00c93037cd84…`
2025-08-26 23:59 UTC · source 2025-08-26	unfinished package	package	55111-783-94	UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`1d862106b807…`	`00c93037cd84…`
2025-05-15 14:59 UTC · source 2025-05-14	unfinished product	product		UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`390b4c401c3f…`	`2c692c2daee3…`
2025-05-15 14:59 UTC · source 2025-05-14	unfinished package	package	55111-783-94	UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`390b4c401c3f…`	`2c692c2daee3…`
2025-04-01 07:37 UTC · source 2025-03-31	unfinished product	product		UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`e30019b0c005…`	`a3f0b14938b7…`
2025-04-01 07:37 UTC · source 2025-03-31	unfinished package	package	55111-783-94	UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`e30019b0c005…`	`a3f0b14938b7…`
2025-03-01 13:19 UTC · source 2025-02-28	unfinished product	product		UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`bbbc9f937eca…`	`946b9c97cf81…`
2025-03-01 13:19 UTC · source 2025-02-28	unfinished package	package	55111-783-94	UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`bbbc9f937eca…`	`946b9c97cf81…`
2025-02-27 05:24 UTC · source 2025-02-26	unfinished product	product		UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`f268b84574a6…`	`26285f5ac5df…`
2025-02-27 05:24 UTC · source 2025-02-26	unfinished package	package	55111-783-94	UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`f268b84574a6…`	`26285f5ac5df…`
2025-02-01 13:13 UTC · source 2025-01-31	unfinished product	product		UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`f764e8902f78…`	`92046438deef…`
2025-02-01 13:13 UTC · source 2025-01-31	unfinished package	package	55111-783-94	UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`f764e8902f78…`	`92046438deef…`
2025-01-20 13:05 UTC · source 2025-01-17	unfinished product	product		UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`68b1e3bced9e…`	`98a755eb8bc6…`
2025-01-20 13:05 UTC · source 2025-01-17	unfinished package	package	55111-783-94	UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`68b1e3bced9e…`	`98a755eb8bc6…`
2024-11-29 20:42 UTC · source 2024-11-29	unfinished product	product		UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`05c55d027831…`	`ca05dca9dc4c…`
2024-11-29 20:42 UTC · source 2024-11-29	unfinished package	package	55111-783-94	UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`05c55d027831…`	`ca05dca9dc4c…`
2024-11-09 02:36 UTC · source 2024-11-08	unfinished product	product		UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`48b4f40e6753…`	`c7c7a00d2afa…`
2024-11-09 02:36 UTC · source 2024-11-08	unfinished package	package	55111-783-94	UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`48b4f40e6753…`	`c7c7a00d2afa…`
2024-10-09 02:27 UTC · source 2024-10-08	unfinished product	product		UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`27f29a85d7e4…`	`1372111e901f…`
2024-10-09 02:27 UTC · source 2024-10-08	unfinished package	package	55111-783-94	UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`27f29a85d7e4…`	`1372111e901f…`
2024-07-10 04:00 UTC · source 2024-07-09	unfinished product	product		UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`8d62ce987f31…`	`9fe9ef23e30d…`
2024-07-10 04:00 UTC · source 2024-07-09	unfinished package	package	55111-783-94	UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`8d62ce987f31…`	`9fe9ef23e30d…`
2024-05-28 21:11 UTC · source 2024-05-28	unfinished product	product		UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`d1e113ab4d42…`	`063ee3eb0a1d…`
2024-05-28 21:11 UTC · source 2024-05-28	unfinished package	package	55111-783-94	UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`d1e113ab4d42…`	`063ee3eb0a1d…`
2024-05-15 03:51 UTC · source 2024-05-14	unfinished product	product		UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`50b4072663b7…`	`eae3003ed65e…`
2024-05-15 03:51 UTC · source 2024-05-14	unfinished package	package	55111-783-94	UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`50b4072663b7…`	`eae3003ed65e…`
2022-04-09 23:13 UTC · source 2022-04-08	unfinished product	product		UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`906f6e251498…`	`bf70b80e44f0…`
2022-04-09 23:13 UTC · source 2022-04-08	unfinished package	package	55111-783-94	UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`906f6e251498…`	`bf70b80e44f0…`
2021-12-27 23:28 UTC · source 2021-12-27	unfinished product	product		UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`6db9cb8d1e19…`	`3449e1ec5b70…`
2021-12-27 23:28 UTC · source 2021-12-27	unfinished package	package	55111-783-94	UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`6db9cb8d1e19…`	`3449e1ec5b70…`
2021-02-18 23:40 UTC · source 2021-02-18	unfinished product	product		UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`8fc7167e32ce…`	`e96bbc724034…`
2021-02-18 23:40 UTC · source 2021-02-18	unfinished package	package	55111-783-94	UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`8fc7167e32ce…`	`e96bbc724034…`
2020-12-18 03:04 UTC · source 2020-12-17	unfinished product	product		UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`4184dd79f89f…`	`545327b3e20f…`
2020-12-18 03:04 UTC · source 2020-12-17	unfinished package	package	55111-783-94	UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`4184dd79f89f…`	`545327b3e20f…`

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…`

Additional Listing Data#

Finished product: Yes
Brand name base: Fexofenadine hydrochloride
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
FEXOFENADINE HYDROCHLORIDE	60 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 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
997420	Internal RxNorm lookup
997488	Internal RxNorm lookup
997501	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
864e3052-5787-bf11-9d17-11274ca2304f	Available on FDA.report

DailyMed Product Concepts#

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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
55111-783-01	EA - Each	55111-783	a8173485-0ae0-4f47-b1e4-bba599b231c6	1	2021-08-05
55111-783-30	EA - Each	55111-783	094e4978-ddce-4c9c-b387-143de74ef654	1	2021-08-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Fexofenadine Hydrochloride	ACTIVE INGREDIENT	2S068B75ZU	FEXOFENADINE HYDROCHLORIDE TABLET [DR. REDDY'S LABORATORIES LIMITED]	7
FEXOFENADINE	ACTIVE MOIETY	E6582LOH6V	FEXOFENADINE HYDROCHLORIDE TABLET [DR. REDDY'S LABORATORIES LIMITED]	7
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	FEXOFENADINE HYDROCHLORIDE TABLET [DR. REDDY'S LABORATORIES LIMITED]	7
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	FEXOFENADINE HYDROCHLORIDE TABLET [DR. REDDY'S LABORATORIES LIMITED]	7
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	FEXOFENADINE HYDROCHLORIDE TABLET [DR. REDDY'S LABORATORIES LIMITED]	7
HYPROMELLOSE 2910 (6 MPA.S)	INACTIVE INGREDIENT	0WZ8WG20P6	FEXOFENADINE HYDROCHLORIDE TABLET [DR. REDDY'S LABORATORIES LIMITED]	7
magnesium stearate	INACTIVE INGREDIENT	70097M6I30	FEXOFENADINE HYDROCHLORIDE TABLET [DR. REDDY'S LABORATORIES LIMITED]	7
mannitol	INACTIVE INGREDIENT	3OWL53L36A	FEXOFENADINE HYDROCHLORIDE TABLET [DR. REDDY'S LABORATORIES LIMITED]	7
polyethylene glycol 400	INACTIVE INGREDIENT	B697894SGQ	FEXOFENADINE HYDROCHLORIDE TABLET [DR. REDDY'S LABORATORIES LIMITED]	7
POWDERED CELLULOSE	INACTIVE INGREDIENT	SMD1X3XO9M	FEXOFENADINE HYDROCHLORIDE TABLET [DR. REDDY'S LABORATORIES LIMITED]	7
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	FEXOFENADINE HYDROCHLORIDE TABLET [DR. REDDY'S LABORATORIES LIMITED]	7
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	FEXOFENADINE HYDROCHLORIDE TABLET [DR. REDDY'S LABORATORIES LIMITED]	7
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	FEXOFENADINE HYDROCHLORIDE TABLET [DR. REDDY'S LABORATORIES LIMITED]	7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
55111-783	FEXOFENADINE HYDROCHLORIDE TABLET [DR. REDDY'S LABORATORIES LIMITED]	19	Current NDC, Legacy NDC	20250508_864e3052-5787-bf11-9d17-11274ca2304f.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 ndc (product): 55111-783
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	864e3052-5787-bf11-9d17-11274ca2304f	19
997488	fexofenadine HCl 30 MG Oral Tablet	PSN	864e3052-5787-bf11-9d17-11274ca2304f	19
997501	fexofenadine HCl 60 MG Oral Tablet	PSN	864e3052-5787-bf11-9d17-11274ca2304f	19
997420	fexofenadine hydrochloride 180 MG Oral Tablet	SCD	864e3052-5787-bf11-9d17-11274ca2304f	19
997488	fexofenadine hydrochloride 30 MG Oral Tablet	SCD	864e3052-5787-bf11-9d17-11274ca2304f	19
997501	fexofenadine hydrochloride 60 MG Oral Tablet	SCD	864e3052-5787-bf11-9d17-11274ca2304f	19
997420	fexofenadine HCl 180 MG 24 HR Oral Tablet	SY	864e3052-5787-bf11-9d17-11274ca2304f	19
997501	fexofenadine HCl 60 MG Oral Tablet	PSN	957b5907-4d6f-507b-72ed-b5509b84b055	6
997501	fexofenadine hydrochloride 60 MG Oral Tablet	SCD	957b5907-4d6f-507b-72ed-b5509b84b055	6
997501	fexofenadine HCl 60 MG Oral Tablet	PSN	98768939-d3d2-b294-4a20-57eba65880ab	5
997501	fexofenadine hydrochloride 60 MG Oral Tablet	SCD	98768939-d3d2-b294-4a20-57eba65880ab	5
997501	fexofenadine HCl 60 MG Oral Tablet	PSN	b0121213-eae1-8429-9986-3b3b26f35e47	4
997501	fexofenadine hydrochloride 60 MG Oral Tablet	SCD	b0121213-eae1-8429-9986-3b3b26f35e47	4
997501	fexofenadine HCl 60 MG Oral Tablet	PSN	c9b5cd8c-668c-b391-e053-2a95a90a7894	1
997501	fexofenadine hydrochloride 60 MG Oral Tablet	SCD	c9b5cd8c-668c-b391-e053-2a95a90a7894	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
55111-783-01	55111078301	100 TABLET in 1 BOTTLE (55111-783-01)	100 tablet	2011-01-03	0000-00-00	No	No	Current
55111-783-24	55111078324	4 BLISTER PACK in 1 CARTON (55111-783-24) / 6 TABLET in 1 BLISTER PACK	4 blister pack	2020-12-01	0000-00-00	No	No	Current
55111-783-28	55111078328	2 BLISTER PACK in 1 CARTON (55111-783-28) / 6 TABLET in 1 BLISTER PACK	2 blister pack	2020-12-01	0000-00-00	No	No	Current
55111-783-30	55111078330	30 TABLET in 1 BOTTLE (55111-783-30)	30 tablet	2011-01-03	0000-00-00	No	No	Current
55111-783-60	55111078360	60 TABLET in 1 BOTTLE (55111-783-60)	60 tablet	2011-01-03	0000-00-00	No	No	Current
55111-783-78	55111078378	10 BLISTER PACK in 1 CARTON (55111-783-78) / 10 TABLET in 1 BLISTER PACK (55111-783-79)	10 blister pack	2011-01-03	0000-00-00	No	No	Current
55111-783-90	55111078390	90 TABLET in 1 BOTTLE (55111-783-90)	90 tablet	2011-01-03	0000-00-00	No	No	Current
55111-783-94	55111078394	4000 TABLET in 1 POUCH (55111-783-94)	4000 tablet	14-OCT-20				Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Fexofenadine HCl Tablets USP	Dr. Reddy's Laboratories Limited \| Dr. Reddy's Laboratories Limited (FTO III) \| Reed-Lane, Inc.	2026-07-09	HUMAN OTC DRUG LABEL	21
Fexofenadine HCl Tablets USP	Dr. Reddy's Laboratories Inc.	2026-07-09	HUMAN OTC DRUG LABEL	5
Fexofenadine HCl Tablets USP	Chain Drug Marketing Association INC	2025-07-18	HUMAN OTC DRUG LABEL	6
Fexofenadine HCl Tablets USP	Rite Aid Corporation	2025-07-18	HUMAN OTC DRUG LABEL	6
Omeprazole Delayed Release Tablets	Kroger Company	2025-07-18	HUMAN OTC DRUG LABEL	5
Fexofenadine HCl Tablets USP	Walgreens Company	2025-07-18	HUMAN OTC DRUG LABEL	5
Fexofenadine HCl Tablets USP	NuCare Pharmaceuticals,Inc.	2021-08-16	HUMAN OTC DRUG LABEL	1