Fexofenadine HCl and Pseudoephedrine HCl

Product NDC: 51316-018
11-digit product format: 513160018
Labeler code: 51316
Product ID: 51316-018_132629da-7f70-439b-3df7-876d0aeb01ee
Type: HUMAN OTC DRUG
Nonproprietary name: Fexofenadine HCl and Pseudoephedrine HCl
Dosage form: TABLET, EXTENDED RELEASE
Route: ORAL
Labeler: CVS Pharmacy, Inc
Application: ANDA079043
Marketing category: ANDA
Marketing start: 2022-11-30
Marketing end: 2026-08-31
Substance: FEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE
Active strength: 180; 240 mg/1; mg/1
Pharmacologic classes: Adrenergic alpha-Agonists [MoA], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], alpha-Adrenergic Agonist [EPC]
NDC exclude flag: No
Current FDA listing: Yes

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 · 6 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	51316-018-15	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	51316-018-10	`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	51316-018-15	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	51316-018-10	`f5e01cc5f278…`	`a2eaf40c39c3…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A079043-002	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	FEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE	180MG;240MG	TABLET, EXTENDED RELEASE / ORAL			2011-06-22

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 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A079043-002	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	180MG;240MG	TABLET, EXTENDED RELEASE / ORAL	2011-06-22	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A079043-002	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	180MG;240MG	TABLET, EXTENDED RELEASE / ORAL	2011-06-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079043-002	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	180MG;240MG	TABLET, EXTENDED RELEASE / ORAL	2011-06-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A079043-002	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	180MG;240MG	TABLET, EXTENDED RELEASE / ORAL	2011-06-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079043-002	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	180MG;240MG	TABLET, EXTENDED RELEASE / ORAL	2011-06-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079043-002	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	180MG;240MG	TABLET, EXTENDED RELEASE / ORAL	2011-06-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079043-002	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	180MG;240MG	TABLET, EXTENDED RELEASE / ORAL	2011-06-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A079043-002	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	180MG;240MG	TABLET, EXTENDED RELEASE / ORAL	2011-06-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A079043-002	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	180MG;240MG	TABLET, EXTENDED RELEASE / ORAL	2011-06-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A079043-002	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	180MG;240MG	TABLET, EXTENDED RELEASE / ORAL	2011-06-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A079043-002	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	180MG;240MG	TABLET, EXTENDED RELEASE / ORAL	2011-06-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A079043-002	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	180MG;240MG	TABLET, EXTENDED RELEASE / ORAL	2011-06-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A079043-002	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	180MG;240MG	TABLET, EXTENDED RELEASE / ORAL	2011-06-22	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A079043-002	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	180MG;240MG	TABLET, EXTENDED RELEASE / ORAL	2011-06-22	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A079043-002	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	180MG;240MG	TABLET, EXTENDED RELEASE / ORAL	2011-06-22	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A079043-002	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	180MG;240MG	TABLET, EXTENDED RELEASE / ORAL	2011-06-22	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A079043-002	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	180MG;240MG	TABLET, EXTENDED RELEASE / ORAL	2011-06-22	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A079043-002	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	180MG;240MG	TABLET, EXTENDED RELEASE / ORAL	2011-06-22	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A079043-002	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	180MG;240MG	TABLET, EXTENDED RELEASE / ORAL	2011-06-22	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A079043-002	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	180MG;240MG	TABLET, EXTENDED RELEASE / ORAL	2011-06-22	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A079043-002	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	180MG;240MG	TABLET, EXTENDED RELEASE / ORAL	2011-06-22	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A079043-002	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	180MG;240MG	TABLET, EXTENDED RELEASE / ORAL	2011-06-22	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A079043-002	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	180MG;240MG	TABLET, EXTENDED RELEASE / ORAL	2011-06-22	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A079043-002	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	180MG;240MG	TABLET, EXTENDED RELEASE / ORAL	2011-06-22	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A079043-002	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	180MG;240MG	TABLET, EXTENDED RELEASE / ORAL	2011-06-22	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A079043-002	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	180MG;240MG	TABLET, EXTENDED RELEASE / ORAL	2011-06-22	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A079043-002	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	180MG;240MG	TABLET, EXTENDED RELEASE / ORAL	2011-06-22	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A079043-002	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	180MG;240MG	TABLET, EXTENDED RELEASE / ORAL	2011-06-22	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A079043-002	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	180MG;240MG	TABLET, EXTENDED RELEASE / ORAL	2011-06-22	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A079043-002	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	180MG;240MG	TABLET, EXTENDED RELEASE / ORAL	2011-06-22	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A079043-002	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	180MG;240MG	TABLET, EXTENDED RELEASE / ORAL	2011-06-22	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A079043-002	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	180MG;240MG	TABLET, EXTENDED RELEASE / ORAL	2011-06-22	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A079043-002	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	180MG;240MG	TABLET, EXTENDED RELEASE / ORAL	2011-06-22	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A079043-002	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	180MG;240MG	TABLET, EXTENDED RELEASE / ORAL	2011-06-22	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A079043-002	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	180MG;240MG	TABLET, EXTENDED RELEASE / ORAL	2011-06-22	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A079043-002	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	180MG;240MG	TABLET, EXTENDED RELEASE / ORAL	2011-06-22	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A079043-002	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	180MG;240MG	TABLET, EXTENDED RELEASE / ORAL	2011-06-22	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A079043-002	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	180MG;240MG	TABLET, EXTENDED RELEASE / ORAL	2011-06-22	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A079043-002	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	180MG;240MG	TABLET, EXTENDED RELEASE / ORAL	2011-06-22	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A079043-002	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	180MG;240MG	TABLET, EXTENDED RELEASE / ORAL	2011-06-22	`e64feba35796…`

Additional Listing Data#

Finished product: Yes
Brand name base: Fexofenadine HCl and Pseudoephedrine HCl

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
FEXOFENADINE HYDROCHLORIDE	180 mg/1
PSEUDOEPHEDRINE HYDROCHLORIDE	240 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
2S068B75ZU	Internal UNII lookup
6V9V2RYJ8N	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
997415	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
3a878985-3a0e-1960-db0e-e3b8fd9d5c63	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
6c13b22c-b3ba-4127-b768-0132dd5ab0d1	Product name	1	20230829
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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
51316-018-10	EA - Each	51316-018	5e0ec218-9e54-4673-969c-38428951ddcb	1	2023-04-07
51316-018-15	EA - Each	51316-018	e5ca728a-d0a8-400b-9c28-552fd38b8bd9	1	2023-04-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
51316-018	FEXOFENADINE HCL AND PSEUDOEPHEDRINE HCL TABLET, EXTENDED RELEASE [CVS PHARMACY, INC]	3	Current NDC, Legacy NDC	20240131_3a878985-3a0e-1960-db0e-e3b8fd9d5c63.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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Fexofenadine HCl and Pseudoephedrine HCl	FEXOFENADINE HCL AND PSEUDOEPHEDRINE HCL	CVS Pharmacy, Inc	3a878985-3a0e-1960-db0e-e3b8fd9d5c63	2026-03-10	Warnings	Exact identifier application applno (ANDA): 079043 application number: ANDA079043 ndc (product): 51316-018
Fexofenadine HCl and Pseudoephedrine HCl	FEXOFENADINE HCL AND PSEUDOEPHEDRINE HCL	Walgreens company	acc07840-a892-a3f4-331d-a211b10842df	2025-07-22	Warnings	Exact identifier application applno (ANDA): 079043 application number: ANDA079043
Fexofenadine HCl and Pseudoephedrine HCl	FEXOFENADINE HCL AND PSEUDOEPHEDRINE HCL	Dr.Reddy's Laboratories Inc	d4e66d84-5ce8-36a1-7a99-2a2a0f38ce19	2025-07-22	Warnings	Exact identifier application applno (ANDA): 079043 application number: ANDA079043
Fexofenadine HCl and Pseudoephedrine HCl	FEXOFENADINE HCL AND PSEUDOEPHEDRINE HCL	Walmart Inc.	883d21cd-4c5f-b502-1465-e346ecc2e2ec	2025-07-22	Warnings	Exact identifier application applno (ANDA): 079043 application number: ANDA079043
Fexofenadine HCl and Pseudoephedrine HCI	FEXOFENADINE HCL AND PSEUDOEPHEDRINE HCI	Dr.Reddy's Laboratories Limited	25cca459-fdd6-3847-2207-dd4f019781b5	2018-12-05	Warnings	Exact identifier application applno (ANDA): 079043 application number: ANDA079043

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
997415	fexofenadine HCl 180 MG / pseudoephedrine HCl 240 MG 24HR Extended Release Oral Tablet	PSN	3a878985-3a0e-1960-db0e-e3b8fd9d5c63	5
997415	24 HR fexofenadine hydrochloride 180 MG / pseudoephedrine hydrochloride 240 MG Extended Release Oral Tablet	SCD	3a878985-3a0e-1960-db0e-e3b8fd9d5c63	5
997415	fexofenadine hydrochloride 180 MG / pseudoephedrine hydrochloride 240 MG 24 HR Extended Release Oral Tablet	SY	3a878985-3a0e-1960-db0e-e3b8fd9d5c63	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
51316-018-10	51316001810	2 BLISTER PACK in 1 CARTON (51316-018-10) / 5 TABLET, EXTENDED RELEASE in 1 BLISTER PACK	2 blister pack	2022-11-30	2026-08-31	No	No	Current
51316-018-15	51316001815	3 BLISTER PACK in 1 CARTON (51316-018-15) / 5 TABLET, EXTENDED RELEASE in 1 BLISTER PACK	3 blister pack	2022-11-30	2026-08-31	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Fexofenadine HCl 180 mg and Pseudoephedrine HCI 240 mg ER Tablets, USP	CVS Pharmacy, Inc \| Dr.Reddy's Laboratories Limited (FTO III)	2026-03-10	HUMAN OTC DRUG LABEL	5