Loratadine and Pseudoephedrine

Product NDC: 70518-0653
Requested package NDC: 70518-0653-1
11-digit product format: 705180653
Labeler code: 70518
Product ID: 70518-0653_e20a3338-3fcc-f984-e053-2a95a90a0693
Type: HUMAN OTC DRUG
Nonproprietary name: loratadine and pseudoephedrine
Dosage form: TABLET, EXTENDED RELEASE
Route: ORAL
Labeler: REMEDYREPACK INC.
Application: ANDA076557
Marketing category: ANDA
Marketing start: 2017-07-31
Marketing end: 0000-00-00
Substance: LORATADINE; PSEUDOEPHEDRINE SULFATE
Active strength: 10 mg/1; mg/1
Pharmacologic classes: Adrenergic alpha-Agonists [MoA], alpha-Adrenergic Agonist [EPC]
NDC exclude flag: No
Listing certified through: 2023-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	70518-0653	70518-0653-1	D	Discontinued by firm		2026-09-09

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 · 12 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`

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
A076557-001	LORATADINE AND PSEUDOEPHEDRINE SULFATE	LORATADINE; PSEUDOEPHEDRINE SULFATE	10MG;240MG	TABLET, EXTENDED RELEASE / ORAL			2004-09-22

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	A076557-001	LORATADINE AND PSEUDOEPHEDRINE SULFATE	10MG;240MG	TABLET, EXTENDED RELEASE / ORAL	2004-09-22	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076557-001	LORATADINE AND PSEUDOEPHEDRINE SULFATE	10MG;240MG	TABLET, EXTENDED RELEASE / ORAL	2004-09-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076557-001	LORATADINE AND PSEUDOEPHEDRINE SULFATE	10MG;240MG	TABLET, EXTENDED RELEASE / ORAL	2004-09-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076557-001	LORATADINE AND PSEUDOEPHEDRINE SULFATE	10MG;240MG	TABLET, EXTENDED RELEASE / ORAL	2004-09-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076557-001	LORATADINE AND PSEUDOEPHEDRINE SULFATE	10MG;240MG	TABLET, EXTENDED RELEASE / ORAL	2004-09-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076557-001	LORATADINE AND PSEUDOEPHEDRINE SULFATE	10MG;240MG	TABLET, EXTENDED RELEASE / ORAL	2004-09-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076557-001	LORATADINE AND PSEUDOEPHEDRINE SULFATE	10MG;240MG	TABLET, EXTENDED RELEASE / ORAL	2004-09-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076557-001	LORATADINE AND PSEUDOEPHEDRINE SULFATE	10MG;240MG	TABLET, EXTENDED RELEASE / ORAL	2004-09-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076557-001	LORATADINE AND PSEUDOEPHEDRINE SULFATE	10MG;240MG	TABLET, EXTENDED RELEASE / ORAL	2004-09-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076557-001	LORATADINE AND PSEUDOEPHEDRINE SULFATE	10MG;240MG	TABLET, EXTENDED RELEASE / ORAL	2004-09-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076557-001	LORATADINE AND PSEUDOEPHEDRINE SULFATE	10MG;240MG	TABLET, EXTENDED RELEASE / ORAL	2004-09-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076557-001	LORATADINE AND PSEUDOEPHEDRINE SULFATE	10MG;240MG	TABLET, EXTENDED RELEASE / ORAL	2004-09-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076557-001	LORATADINE AND PSEUDOEPHEDRINE SULFATE	10MG;240MG	TABLET, EXTENDED RELEASE / ORAL	2004-09-22	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076557-001	LORATADINE AND PSEUDOEPHEDRINE SULFATE	10MG;240MG	TABLET, EXTENDED RELEASE / ORAL	2004-09-22	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076557-001	LORATADINE AND PSEUDOEPHEDRINE SULFATE	10MG;240MG	TABLET, EXTENDED RELEASE / ORAL	2004-09-22	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076557-001	LORATADINE AND PSEUDOEPHEDRINE SULFATE	10MG;240MG	TABLET, EXTENDED RELEASE / ORAL	2004-09-22	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076557-001	LORATADINE AND PSEUDOEPHEDRINE SULFATE	10MG;240MG	TABLET, EXTENDED RELEASE / ORAL	2004-09-22	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076557-001	LORATADINE AND PSEUDOEPHEDRINE SULFATE	10MG;240MG	TABLET, EXTENDED RELEASE / ORAL	2004-09-22	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076557-001	LORATADINE AND PSEUDOEPHEDRINE SULFATE	10MG;240MG	TABLET, EXTENDED RELEASE / ORAL	2004-09-22	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076557-001	LORATADINE AND PSEUDOEPHEDRINE SULFATE	10MG;240MG	TABLET, EXTENDED RELEASE / ORAL	2004-09-22	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076557-001	LORATADINE AND PSEUDOEPHEDRINE SULFATE	10MG;240MG	TABLET, EXTENDED RELEASE / ORAL	2004-09-22	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076557-001	LORATADINE AND PSEUDOEPHEDRINE SULFATE	10MG;240MG	TABLET, EXTENDED RELEASE / ORAL	2004-09-22	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076557-001	LORATADINE AND PSEUDOEPHEDRINE SULFATE	10MG;240MG	TABLET, EXTENDED RELEASE / ORAL	2004-09-22	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076557-001	LORATADINE AND PSEUDOEPHEDRINE SULFATE	10MG;240MG	TABLET, EXTENDED RELEASE / ORAL	2004-09-22	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076557-001	LORATADINE AND PSEUDOEPHEDRINE SULFATE	10MG;240MG	TABLET, EXTENDED RELEASE / ORAL	2004-09-22	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076557-001	LORATADINE AND PSEUDOEPHEDRINE SULFATE	10MG;240MG	TABLET, EXTENDED RELEASE / ORAL	2004-09-22	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076557-001	LORATADINE AND PSEUDOEPHEDRINE SULFATE	10MG;240MG	TABLET, EXTENDED RELEASE / ORAL	2004-09-22	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076557-001	LORATADINE AND PSEUDOEPHEDRINE SULFATE	10MG;240MG	TABLET, EXTENDED RELEASE / ORAL	2004-09-22	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076557-001	LORATADINE AND PSEUDOEPHEDRINE SULFATE	10MG;240MG	TABLET, EXTENDED RELEASE / ORAL	2004-09-22	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076557-001	LORATADINE AND PSEUDOEPHEDRINE SULFATE	10MG;240MG	TABLET, EXTENDED RELEASE / ORAL	2004-09-22	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076557-001	LORATADINE AND PSEUDOEPHEDRINE SULFATE	10MG;240MG	TABLET, EXTENDED RELEASE / ORAL	2004-09-22	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076557-001	LORATADINE AND PSEUDOEPHEDRINE SULFATE	10MG;240MG	TABLET, EXTENDED RELEASE / ORAL	2004-09-22	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076557-001	LORATADINE AND PSEUDOEPHEDRINE SULFATE	10MG;240MG	TABLET, EXTENDED RELEASE / ORAL	2004-09-22	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076557-001	LORATADINE AND PSEUDOEPHEDRINE SULFATE	10MG;240MG	TABLET, EXTENDED RELEASE / ORAL	2004-09-22	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076557-001	LORATADINE AND PSEUDOEPHEDRINE SULFATE	10MG;240MG	TABLET, EXTENDED RELEASE / ORAL	2004-09-22	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076557-001	LORATADINE AND PSEUDOEPHEDRINE SULFATE	10MG;240MG	TABLET, EXTENDED RELEASE / ORAL	2004-09-22	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076557-001	LORATADINE AND PSEUDOEPHEDRINE SULFATE	10MG;240MG	TABLET, EXTENDED RELEASE / ORAL	2004-09-22	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076557-001	LORATADINE AND PSEUDOEPHEDRINE SULFATE	10MG;240MG	TABLET, EXTENDED RELEASE / ORAL	2004-09-22	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076557-001	LORATADINE AND PSEUDOEPHEDRINE SULFATE	10MG;240MG	TABLET, EXTENDED RELEASE / ORAL	2004-09-22	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A076557-001	LORATADINE AND PSEUDOEPHEDRINE SULFATE	10MG;240MG	TABLET, EXTENDED RELEASE / ORAL	2004-09-22	`e64feba35796…`

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 2 · 23 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Loratadine and Pseudoephedrine	LORATADINE AND PSEUDOEPHEDRINE	Ohm Laboratories Inc.	556b89ef-3b51-4faa-afb4-767a5c1b6422	2026-06-02	Warnings	Exact identifier application applno (ANDA): 076557 application number: ANDA076557
Loratadine and Pseudoephedrine	LORATADINE AND PSEUDOEPHEDRINE	Sportpharm LLC	2b432b67-f9f3-45e2-8306-2d4080152f99	2026-02-06	Warnings	Exact identifier application applno (ANDA): 076557 application number: ANDA076557
ALLERGY RELIEF-D	LORATADINE AND PSEUDOEPHEDRINE	CVS Pharmacy	0b26004d-f741-48e1-bf2b-ec4af8150160	2025-11-19	Warnings	Exact identifier application applno (ANDA): 076557 application number: ANDA076557
Loratadine and Pseudoephedrine Sulfate	LORATADINE AND PSEUDOEPHEDRINE SULFATE	Major Pharmaceuticals	2620a150-4a2c-4fa2-a0e4-6aafe9e496c3	2025-09-08	Warnings	Exact identifier application applno (ANDA): 076557 application number: ANDA076557
Loratadine and Pseudoephedrine	LORATADINE AND PSEUDOEPHEDRINE	Ohm Laboratories Inc.	bbe83464-a582-469f-8fac-f98e804d96fe	2025-07-15	Warnings	Exact identifier application applno (ANDA): 076557 application number: ANDA076557
Loratadine and Pseudoephedrine Sulfate	LORATADINE AND PSEUDOEPHEDRINE SULFATE	The Kroger Company	43e53450-9630-4161-8008-22267a785343	2025-04-24	Warnings	Exact identifier application applno (ANDA): 076557 application number: ANDA076557
Loratadine and Pseudoephedrine Sulfate	LORATADINE AND PSEUDOEPHEDRINE SULFATE	WAL-MART STORES, INC	59453133-20bf-4f13-855a-b47b22302d8b	2025-04-14	Warnings	Exact identifier application applno (ANDA): 076557 application number: ANDA076557
Loratadine and Pseudoephedrine Sulfate	LORATADINE AND PSEUDOEPHEDRINE SULFATE	Strategic Sourcing Services LLC	cdecad62-bf1e-43fb-b4be-8fc54b63e4ae	2024-11-22	Warnings	Exact identifier application applno (ANDA): 076557 application number: ANDA076557
Loratadine and Pseudoephedrine Sulfate	LORATADINE AND PSEUDOEPHEDRINE SULFATE	Strategic Sourcing Services LLC	48bfc938-d97d-4b49-8637-3b00ac870902	2024-11-21	Warnings	Exact identifier application applno (ANDA): 076557 application number: ANDA076557
Loratadine and Pseudoephedrine Sulfate	LORATADINE AND PSEUDOEPHEDRINE SULFATE	Meijer Distribution, Inc.	eb6e2196-2f4f-4fe9-9c80-b4ce89da8db4	2023-08-23	Warnings	Exact identifier application applno (ANDA): 076557 application number: ANDA076557
KIRKLAND SIGNATURE ALLERCLEAR D 24 HR Extended Release	LORATADINE AND PSEUDOEPHEDRINE SULFATE	Kirkland-COSTCO WHOLESALE COMPANY	b8e35d9f-5ad7-4cd5-b359-18f7dfe586c6	2023-08-23	Warnings	Exact identifier application applno (ANDA): 076557 application number: ANDA076557
Loratadine and Pseudoephedrine	LORATADINE AND PSEUDOEPHEDRINE	STRATEGIC SOURCING SERVICES LLC	07f03186-438d-41b7-a871-f05a38733329	2023-08-11	Warnings	Exact identifier application applno (ANDA): 076557 application number: ANDA076557
Loratadine and Pseudoephedrine	LORATADINE AND PSEUDOEPHEDRINE SULFATE	Rite Aid	bb0f7653-378f-40b1-8ead-77999fcbd87b	2022-05-09	Warnings	Exact identifier application applno (ANDA): 076557 application number: ANDA076557
Leader Allergy Relief D-24	LORATADINE AND PSEUDOEPHEDRINE SULFATE	Cardinal Health	f1bcd2aa-e8cd-4364-87b4-c544537cdb50	2022-03-22	Warnings	Exact identifier application applno (ANDA): 076557 application number: ANDA076557
Loratadine and Pseudoephedrine Sulfate	LORATADINE AND PSEUDOEPHEDRINE SULFATE	Safeway Inc.	c1e1e0ca-30df-4ace-a7b6-c66a3c5ab676	2021-12-21	Warnings	Exact identifier application applno (ANDA): 076557 application number: ANDA076557
Loratadine and Pseudoephedrine	LORATADINE AND PSEUDOEPHEDRINE	Walgreen Company	ab7e4406-997a-43be-af99-a07a2da870da	2021-08-25	Warnings	Exact identifier application applno (ANDA): 076557 application number: ANDA076557
Loratadine and Pseudoephedrine	LORATADINE AND PSEUDOEPHEDRINE	AMERISOURCE BERGEN	96635cb0-8c78-4c3a-8294-2804ff26f90a	2021-06-03	Warnings	Exact identifier application applno (ANDA): 076557 application number: ANDA076557
Loratadine and Pseudoephedrine Sulfate	LORATADINE AND PSEUDOEPHEDRINE SULFATE	Amerisource Bergen	3013f7b8-d87c-41ab-ba6f-c4d1b39cb1c1	2021-06-03	Warnings	Exact identifier application applno (ANDA): 076557 application number: ANDA076557
Loratadine and Pseudoephedrine Sulfate	LORATADINE AND PSEUDOEPHEDRINE SULFATE	STRATEGIC SOURCING SERVICES	114b5e7c-973a-4a34-8538-a214de090b39	2020-07-30	Warnings	Exact identifier application applno (ANDA): 076557 application number: ANDA076557
Loratadine and Pseudoephedrine	LORATADINE AND PSEUDOEPHEDRINE	Proficient Rx LP	ca1a6552-d082-4312-ba17-0055e8554eb9	2019-12-01	Warnings	Exact identifier application applno (ANDA): 076557 application number: ANDA076557

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
7AJO3BO7QN	LORATADINE	79794-75-5	LORATADINE
Y9DL7QPE6B	PSEUDOEPHEDRINE SULFATE	7460-12-0	PSEUDOEPHEDRINE SULFATE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
70518-0653-1	70518065301	1 BLISTER PACK in 1 CARTON (70518-0653-1) > 15 TABLET, EXTENDED RELEASE in 1 BLISTER PACK	1 blister pack	2021-09-10	0000-00-00	No	No	Current