Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride

Product NDC: 56062-999
11-digit product format: 560620999
Labeler code: 56062
Product ID: 56062-999_250de750-13e2-4bc2-b7a4-118c94f4162e
Type: HUMAN OTC DRUG
Nonproprietary name: Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride
Dosage form: TABLET, FILM COATED, EXTENDED RELEASE
Route: ORAL
Labeler: PUBLIX SUPER MARKETS INC
Application: ANDA090818
Marketing category: ANDA
Marketing start: 2019-04-01
Marketing end: 0000-00-00
Substance: FEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE
Active strength: 60 mg/1; mg/1
NDC exclude flag: No
Listing certified through: 2020-12-31
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	56062-999		I	Inactivated by FDA		2026-08-03
excluded package	package	56062-999	56062-999-30	I	Inactivated by FDA		2026-08-03

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	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	56062-999-30	`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	56062-999-30	`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	56062-999-30	`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	56062-999-30	`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	56062-999-30	`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	56062-999-30	`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	56062-999-30	`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	56062-999-30	`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	56062-999-30	`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	56062-999-30	`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	56062-999-30	`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	56062-999-30	`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	56062-999-30	`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	56062-999-30	`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	56062-999-30	`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	56062-999-30	`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	56062-999-30	`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	56062-999-30	`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	56062-999-30	`8dfbde2a14a4…`	`c9ff85d89658…`

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

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A090818-001	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	FEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL			2015-01-29

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 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A090818-001	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2015-01-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090818-001	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2015-01-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090818-001	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2015-01-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090818-001	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2015-01-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090818-001	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2015-01-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090818-001	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2015-01-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090818-001	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2015-01-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090818-001	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2015-01-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090818-001	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2015-01-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090818-001	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2015-01-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090818-001	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2015-01-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090818-001	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2015-01-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090818-001	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2015-01-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090818-001	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2015-01-29	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090818-001	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2015-01-29	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090818-001	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2015-01-29	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090818-001	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2015-01-29	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090818-001	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2015-01-29	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090818-001	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2015-01-29	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090818-001	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2015-01-29	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090818-001	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2015-01-29	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A090818-001	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2015-01-29	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A090818-001	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2015-01-29	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A090818-001	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2015-01-29	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A090818-001	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2015-01-29	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A090818-001	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2015-01-29	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A090818-001	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2015-01-29	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A090818-001	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2015-01-29	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A090818-001	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2015-01-29	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A090818-001	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2015-01-29	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A090818-001	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2015-01-29	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A090818-001	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2015-01-29	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A090818-001	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2015-01-29	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A090818-001	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2015-01-29	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A090818-001	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2015-01-29	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A090818-001	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2015-01-29	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A090818-001	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2015-01-29	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A090818-001	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2015-01-29	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A090818-001	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2015-01-29	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A090818-001	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2015-01-29	`cb3db0bc1861…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
ba088a92-ab5e-b2d4-e908-f5ea691b7587	Product name	7	20210201
0fdb98e2-b951-a1ce-5715-2b187ba500ef	Product name	4	20170718
e974e22d-8688-7d92-1e87-40c1079e170c	Product name	3	20151125
e8718272-64cb-4436-969b-176c3067c8f4	Product name	1	20150609
30c51294-7ae9-8007-7de6-58222684a0be	Product name	1	20140508
4f26f669-fc6c-40ef-9e26-1c7b2390ee66	Product name	1	20140508
70a83adc-6047-bbea-5a08-dfd304aa47d2	Product name	1	20140508
858ce051-9941-aafc-8c7c-44a8e0227463	Product name	1	20140508
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
56062-999-30	2021-01-29	C162847	48780-1	ba0f9c33-4524-a910-e053-dadaa90a0b85	Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride Extended-Release Tablets, 60 mg/120 mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
56062-999-30	Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride	30 in 1 BLISTER PACK	TABLET, FILM COATED, EXTENDED RE	30		2
56062-999-30	Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride	1 in 1 CARTON	TABLET, FILM COATED, EXTENDED RE	1		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
56062-999	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [PUBLIX SUPER MARKETS INC]	2	Legacy NDC, 2 package rows	20190529_728f8a1f-7dd7-4991-8b30-cccf7be32185.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 · 9 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	AmeriSource Bergen	4a8df3c9-bed3-4371-a1c1-59afe12203e2	2025-11-14	Warnings	Exact identifier application applno (ANDA): 090818 application number: ANDA090818
Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	Ohm Laboratories Inc.	87ab4578-84de-475d-a4b0-eec969f17253	2025-11-13	Warnings	Exact identifier application applno (ANDA): 090818 application number: ANDA090818
Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	Sun Pharmaceutical Industries, Inc.	8afc0167-17bf-4ccd-91c9-8fb9c4e241c1	2025-03-11	Warnings	Exact identifier application applno (ANDA): 090818 application number: ANDA090818
Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	PUBLIX SUPER MARKETS, INC	75236b23-af51-40b6-ad1b-f62a27093a16	2024-10-10	Warnings	Exact identifier application applno (ANDA): 090818 application number: ANDA090818
Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	walgreens	1ed05c85-7a1c-440d-a5d7-e229528cedcd	2024-05-28	Warnings	Exact identifier application applno (ANDA): 090818 application number: ANDA090818
Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	CVS Pharmacy	45d3ad69-a80a-4f91-9c9b-8b19a30144a3	2024-04-26	Warnings	Exact identifier application applno (ANDA): 090818 application number: ANDA090818
Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	H E B	5167ab78-f898-47ec-8baf-843269469d10	2018-07-18	Warnings	Exact identifier application applno (ANDA): 090818 application number: ANDA090818
Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	AmeriSource Bergen	c20f780c-562b-4eb6-940d-2973382118eb	2018-05-31	Warnings	Exact identifier application applno (ANDA): 090818 application number: ANDA090818
Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	CVS Pharmacy	02476e5a-0463-4223-8dc5-8bbe787d38dc	2018-05-31	Warnings	Exact identifier application applno (ANDA): 090818 application number: ANDA090818

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
2S068B75ZU	FEXOFENADINE HYDROCHLORIDE	153439-40-8	FEXOFENADINE HYDROCHLORIDE
6V9V2RYJ8N	PSEUDOEPHEDRINE HYDROCHLORIDE	345-78-8	PSEUDOEPHEDRINE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
997406	fexofenadine HCl 60 MG / pseudoephedrine HCl 120 MG 12HR Extended Release Oral Tablet	PSN	728f8a1f-7dd7-4991-8b30-cccf7be32185	2
997406	12 HR fexofenadine hydrochloride 60 MG / pseudoephedrine hydrochloride 120 MG Extended Release Oral Tablet	SCD	728f8a1f-7dd7-4991-8b30-cccf7be32185	2
997406	fexofenadine hydrochloride 60 MG / pseudoephedrine hydrochloride 120 MG 12 HR Extended Release Oral Tablet	SY	728f8a1f-7dd7-4991-8b30-cccf7be32185	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
56062-999-30	56062099930	30 in 1 BLISTER PACK	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride Extended-Release Tablets, 60 mg/120 mg	PUBLIX SUPER MARKETS INC \| Sun Pharmaceutical Industries Limited	2019-05-24	Human OTC Drug Label	2